What is sodium bicarbonate

Sodium bicarbonate (NaHCO₃), also known as baking soda, is used to relieve heartburn, sour stomach, or acid indigestion by neutralizing excess stomach acid. When used for this purpose, sodium bicarbonate is said to belong to the group of medicines called antacids. Sodium bicarbonate may be used to treat the symptoms of stomach or duodenal ulcers. Sodium bicarbonate is also used to make the blood and urine more alkaline in certain conditions.

Sodium bicarbonate is a white, crystalline powder that is commonly used as a pH buffering agent, an electrolyte replenisher, systemic alkalizer and in topical cleansing solutions. Sodium bicarbonate is the monosodium salt of carbonic acid with alkalinizing and electrolyte replacement properties. Slightly alkaline (bitter) taste, pH (of freshly prepared 0.1 molar aqueous solution): 8.3 at 77 °F and pH (of saturated solution): 8-9. Sodium bicarbonate in water dissociates to provide sodium (Na⁺) and bicarbonate (HCO3¯ ) ions. Sodium (Na⁺) is the principal cation of the extracellular fluid and plays a large part in the therapy of fluid and electrolyte disturbances. Bicarbonate (HCO3¯ ) is a normal constituent of body fluids and the normal plasma level ranges from 24 to 31 mEq/liter. Ion formation increases plasma bicarbonate and buffers excess hydrogen ion concentration, resulting in raised blood pH. Plasma concentration is regulated by the kidney through acidification of the urine when there is a deficit or by alkalinization of the urine when there is an excess. Bicarbonate anion is considered “labile” since at a proper concentration of hydrogen ion (H⁺) it may be converted to carbonic acid (H2CO3) and thence to its volatile form, carbon dioxide (CO2) excreted by the lung. Normally a ratio of 1:20 (carbonic acid; bicarbonate) is present in the extracellular fluid. In a healthy adult with normal kidney function, practically all the glomerular filtered bicarbonate ion is reabsorbed; less than 1% is excreted in the urine.

Sodium bicarbonate should not be given to young children (up to 6 years of age) unless prescribed by their doctor. Since children cannot usually describe their symptoms very well, a doctor should check the child before giving sodium bicarbonate. The child may have a condition that needs other treatment. If so, sodium bicarbonate will not help and may even cause unwanted effects or make the condition worse.

Sodium bicarbonate for oral use is available without a prescription.

This product is available in the following dosage forms:

• Tablet
• Solution
• Powder
• Granule
• Capsule

Storage

Store sodium bicarbonate medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Taking sodium bicarbonate with food, alcohol and other medicines

It’s best to take sodium bicarbonate with food or soon after eating because this is when you’re most likely to get indigestion or heartburn.

The effect of sodium bicarbonate medicine may also last longer if taken with food.

Sodium bicarbonate can affect how well other medicines work, so don’t take other medicines within two to four hours of taking an antacid (see Drug Interactions below).

You can drink alcohol while taking sodium bicarbonate, but alcohol can irritate your stomach and make your symptoms worse.

Precautions

If this medicine has been ordered by your doctor and if you will be taking it regularly for a long time, your doctor should check your progress at regular visits. This is to make sure the medicine does not cause unwanted effects.

Sodium bicarbonate is contraindicated in patients with chloride loss from vomiting or from continuous gastrointestinal suction, who are receiving diuretics that are known to produce a hypochloremic alkalosis, with metabolic or respiratory alkalosis, with hypocalcemia in which alkalosis may produce tetany, hypertension, convulsions or congestive heart failure, and in patients in whom the administration of sodium would be clinically detrimental.

Do not take sodium bicarbonate:

• Within 1 to 2 hours of taking other medicine by mouth. To do so may keep the other medicine from working properly.
• For a long period of time. To do so may increase the chance of side effects.

For patients on a sodium-restricted diet:

Sodium bicarbonate contains a large amount of sodium. If you have any questions about this, check with your health care professional.

For patients taking sodium bicarbonate as an antacid:

• Do not take sodium bicarbonate medicine if you have any signs of appendicitis (such as stomach or lower abdominal pain, cramping, bloating, soreness,
• nausea, or vomiting). Instead, check with your doctor as soon as possible.
• Do not take sodium bicarbonate with large amounts of milk or milk products. To do so may increase the chance of side effects.
• Do not take sodium bicarbonate for more than 2 weeks or if the problem comes back often. Instead, check with your doctor. Antacids should be used only for occasional relief, unless otherwise directed by your doctor.

Serum bicarbonate

Bicarbonate (HCO₃⁻, sometimes reported as total CO₂) is an electrolyte, a negatively charged ion that is used by the body to help maintain the body’s acid-base (pH) balance. It also works with the other electrolytes (sodium, potassium, and chloride) to maintain electrical neutrality at the cellular level. This test measures the total amount of carbon dioxide (CO2) in the blood, which occurs mostly in the form of bicarbonate (HCO3-). The CO₂ is mainly a by-product of various metabolic processes.

The lungs provide oxygen and regulate CO2. The CO2 is produced by the body and is in balance with bicarbonate bicarbonate (HCO₃⁻). The overall balance of these chemicals is an indication of the functional well-being of several basic body functions. They are important in maintaining a wide range of body functions, including heart and skeletal muscle contraction and nerve impulse conduction.

Sodium, along with other electrolytes such as potassium, chloride, and bicarbonate (or total CO₂), helps cells function normally and helps regulate the amount of fluid in the body. While sodium is present in all body fluids, it is found in the highest concentration in the blood and in the fluid outside of the body’s cells. This extracellular sodium, as well as all body water, is regulated by the kidneys.

Measuring bicarbonate as part of an electrolyte or metabolic panel may help diagnose an electrolyte imbalance or acidosis or alkalosis. Acidosis and alkalosis describe the abnormal conditions that result from an imbalance in the pH of the blood caused by an excess of acid or alkali (base). This imbalance is typically caused by some underlying condition or disease.

The body’s maintenance of a healthy pH range for blood and tissues that is slightly basic (pH between 7.35 – 7.45). This balance is achieved through the use of systems in the blood (which help to minimize pH changes) and by the lungs and kidneys, which eliminate excess amounts of acids or bases from the body.

The lungs and kidneys are the major organs involved in regulating blood pH through the removal of excess bicarbonate.

• The lungs flush acid out of the body by exhaling CO₂. Raising and lowering the respiratory rate alters the amount of CO₂ that is breathed out, and this can affect blood pH within minutes.
• The kidneys eliminate acids in the urine and they regulate the concentration of bicarbonate (HCO₃⁻, a base) in blood. Acid-base changes due to increases or decreases in HCO₃⁻ concentration occur more slowly than changes in CO₂, taking hours or days.

Any disease or condition that affects the lungs, kidneys, metabolism, or breathing has the potential to cause acidosis or alkalosis.

The bicarbonate test gives a healthcare practitioner a rough estimate of a patient’s acid-base balance. This is usually sufficient, but measurements of gases dissolved in the blood (blood gases) may be done if more information is needed. Bicarbonate is typically measured along with sodium, potassium, and possibly chloride in an electrolyte panel as it is the balance of these molecules that gives the healthcare practitioner the most information.

The bicarbonate (or total CO₂) test is usually ordered along with sodium, potassium, and chloride as part of an electrolyte panel. The electrolyte panel is used to help detect, evaluate, and monitor electrolyte imbalances and/or acid-base (pH) imbalances (acidosis or alkalosis). It may be ordered as part of a routine exam or to help evaluate a variety of chronic or acute illnesses.

This testing may be ordered when acidosis or alkalosis is suspected or when someone has an acute condition with symptoms that may include the following:

• Prolonged vomiting and/or diarrhea
• Weakness, fatigue
• Difficulty breathing (respiratory distress)

Electrolytes may be ordered at regular intervals when a person has a disease or condition or is taking a medication that can cause an electrolyte imbalance. Electrolyte panels or basic metabolic panels are commonly used to monitor treatment of certain problems, including high blood pressure (hypertension), heart failure, and liver and kidney disease.

An electrolyte panel may be used to help monitor conditions, such as kidney disease, lung disorders, and high blood pressure (hypertension). When acidosis or alkalosis is identified, bicarbonate (as part of the electrolyte panel) and blood gases may be ordered to evaluate the severity of the pH imbalance. These tests help determine whether it is primarily respiratory (due to an imbalance between the amount of oxygen coming in and CO₂ being released) or metabolic (due to increased or decreased amounts of bicarbonate in the blood). They also help monitor treatment until acid-base balance is restored.

What does the test bicarbonate result mean?

When bicarbonate levels are higher or lower than normal, it suggests that the body is having trouble maintaining its acid-base balance, either by failing to remove carbon dioxide through the lungs or the kidneys or perhaps because of an electrolyte imbalance, particularly a deficiency of potassium. Both of these imbalances may be due to a wide range of conditions.

Examples of causes of a low bicarbonate level include:

• Addison disease
• Chronic diarrhea
• Diabetic ketoacidosis
• Metabolic acidosis
• Respiratory alkalosis, which can be caused by hyperventilation
• Shock
• Kidney disease
• Ethylene glycol or methanol poisoning
• Salicylate (aspirin) overdose
• Drugs that may decrease bicarbonate levels include methicillin, nitrofurantoin, tetracycline, thiazide diuretics, and triamterene.

Examples of causes of a high bicarbonate level include:

• Severe, prolonged vomiting and/or diarrhea
• Lung diseases, including COPD
• Cushing syndrome
• Conn syndrome
• Metabolic alkalosis
• Some drugs may increase bicarbonate levels including fludrocortisone, barbiturates, bicarbonates, hydrocortisone, loop diuretics, and steroids.

If bicarbonate levels are too high or low, what treatments can help?

If your bicarbonate is high or low, your healthcare practitioner will identify and treat the underlying cause. For example, high bicarbonate may be caused by emphysema, which may be treated with oxygen therapy and medications, or by severe diarrhea or vomiting, which would be addressed by treating the cause of the diarrhea or vomiting. Low bicarbonate may be caused by diabetic ketoacidosis, for example, which can be addressed in part by fluid and electrolyte replacement and insulin therapy.

If I’ve had a bicarbonate (total CO₂) test, why does my doctor want to test my blood gases?

Blood gas tests, in which blood is drawn from an artery instead of a vein, can give your healthcare practitioner more information about your acid-base balance. They can tell your provider whether your lungs are working properly to keep oxygen and carbon dioxide at healthy levels.

Sodium bicarbonate injection

Sodium Bicarbonate Injection is a sterile, nonpyrogenic, hypertonic solution of Sodium Bicarbonate (NaHCO₃) in water for injection for administration by the intravenous route as an electrolyte replenisher and systemic alkalizer.

Solution is offered in 8.4% concentration. The solution has an approximate pH of 8.0 (7.5 to 8.5). Carbon dioxide may have been added to adjust the pH of the solution to approximately 8.0.

How is sodium bicarbonate injection supplied

Sodium Bicarbonate Injection, USP is supplied in the following dosage form.

In 50 mL single-dose packages containing a Luer-Jet™ Luer-Lock Prefilled Syringe.

10 individual cartons shrink wrapped as a group of 10 cartons.

The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only for use as a single-dose injection. When smaller doses are required, the unused portion should be discarded with the entire unit.

Sodium Bicarbonate, 84 mg is equal to one milliequivalent each of sodium (Na⁺) and bicarbonate (HCO3¯ ) . Sodium Bicarbonate, USP is chemically designated NaHCO₃, a white crystalline powder soluble in water. Water for Injection, USP is chemically designated H2O.

Sodium Bicarbonate Injection- Clinical Pharmacology

Intravenous Sodium Bicarbonate therapy increases plasma bicarbonate, buffers excess hydrogen ion concentration, raises blood pH and reverses the clinical manifestations of acidosis.

Indications and Usage for Sodium Bicarbonate Injection

Sodium Bicarbonate Injection, USP is indicated in the treatment of metabolic acidosis which may occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis. Sodium Bicarbonate is further indicated in the treatment of certain drug intoxications, including barbiturates (where dissociation of the barbiturate-protein complex is desired), in poisoning by salicylates or methyl alcohol and in hemolytic reactions requiring alkalinization of the urine to diminish nephrotoxicity of hemoglobin and its breakdown products. Sodium Bicarbonate also is indicated in severe diarrhea which is often accompanied by a significant loss of bicarbonate.

Treatment of metabolic acidosis should, if possible, be superimposed on measures designed to control the basic cause of the acidosis – e.g., insulin in uncomplicated diabetes, blood volume restoration in shock. But since an appreciable time interval may elapse before all of the ancillary effects are brought about, bicarbonate therapy is indicated to minimize risks inherent to the acidosis itself.

Vigorous bicarbonate therapy is required in any form of metabolic acidosis where a rapid increase in plasma total CO2 content is crucial – e.g., cardiac arrest, circulatory insufficiency due to shock or severe dehydration, and in severe primary lactic acidosis or severe diabetic acidosis.

Sodium Bicarbonate Injection Contraindications

Sodium Bicarbonate Injection, USP is contraindicated in patients who are losing chloride by vomiting or from continuous gastrointestinal suction, and in patients receiving diuretics known to produce a hypochloremic alkalosis.

Sodium Bicarbonate Injection Warnings

Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency and in clinical states in which there exists edema with sodium retention.

In patients with diminished renal function, administration of solutions containing sodium ions may result in sodium retention.

The intravenous administration of these solutions can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema.

Sodium Bicarbonate Injection Precautions

General

Do not use unless solution is clear and the container or seal is intact. Discard unused portion.

The potentially large loads of sodium given with bicarbonate require that caution be exercised in the use of Sodium Bicarbonate in patients with congestive heart failure or other edematous or sodium-retaining states, as well as in patients with oliguria or anuria.

Caution must be exercised in the administration of parenteral fluids, especially those containing sodium ions, to patients receiving corticosteroids or corticotropin.

Potassium depletion may predispose to metabolic alkalosis and coexistent hypocalcemia may be associated with carpopedal spasm as the plasma pH rises. These dangers can be minimized if such electrolyte imbalances are appropriately treated prior to or concomitantly with bicarbonate infusion.

Laboratory Tests

The aim of all bicarbonate therapy is to produce a substantial correction of the low total CO2 content and blood pH, but the risks of overdosage and alkalosis should be avoided. Hence, repeated fractional doses and periodic monitoring by appropriate laboratory tests are recommended to minimize the possibility of overdosage.

Sodium Bicarbonate Injection Drug Interactions

Additives may be incompatible; norepinephrine and dobutamine are incompatible with Sodium Bicarbonate solution.

The addition of Sodium Bicarbonate to parenteral solutions containing calcium should be avoided, except where compatibility has been previously established. Precipitation or haze may result from Sodium Bicarbonate/calcium admixtures. NOTE: Do not use the injection if it contains precipitate.

Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store.

Pregnancy: Teratogenic Effects

Pregnancy Category C. Animal reproduction studies have not been conducted with Sodium Bicarbonate. It is also not known whether Sodium Bicarbonate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Bicarbonate should be given to a pregnant woman only if clearly needed.

Pediatric

Rapid injection (10 mL/min) of hypertonic Sodium Bicarbonate Injection, USP solutions into neonates and children under two years of age may produce hypernatremia, a decrease in cerebrospinal fluid pressure and possible intracranial hemorrhage. The rate of administration in such patients should therefore be limited to no more than 8 mEq/kg/day. A 4.2% solution may be preferred for such slow administration. In emergencies such as cardiac arrest, the risk of rapid infusion must be weighed against the potential for fatality due to acidosis.

Geriatric

Clinical studies of Sodium Bicarbonate Injection, USP did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy.

Sodium Bicarbonate Injection Adverse Reactions

Overly aggressive therapy with Sodium Bicarbonate Injection, USP can result in metabolic alkalosis (associated with muscular twitchings, irritability, and tetany) and hypernatremia.

Inadvertent extravasation of intravenously administered hypertonic solutions of Sodium Bicarbonate have been reported to cause chemical cellulitis because of their alkalinity, with tissue necrosis, ulceration or sloughing at the site of infiltration. Prompt elevation of the part, warmth and local injection of lidocaine or hyaluronidase are recommended to reduce the likelihood of tissue sloughing from extravasated I.V. solutions.

Sodium Bicarbonate Injection Overdosage

Should alkalosis result, the bicarbonate should be stopped and the patient managed according to the degree of alkalosis present. 0.9% sodium chloride injection intravenous may be given; potassium chloride also may be indicated if there is hypokalemia. Severe alkalosis may be accompanied by hyperirritability or tetany and these symptoms may be controlled by calcium gluconate. An acidifying agent such as ammonium chloride may also be indicated in severe alkalosis.

Sodium Bicarbonate Injection Dosage and Administration

Sodium Bicarbonate Injection, USP is administered by the intravenous route.

In cardiac arrest, a rapid intravenous dose of one to two 50 mL syringes (44.6 to 100 mEq) may be given initially and continued at a rate of 50 mL (44.6 to 50 mEq) every 5 to 10 minutes if necessary (as indicated by arterial pH and blood gas monitoring) to reverse the acidosis. Caution should be observed in emergencies where very rapid infusion of large quantities of bicarbonate is indicated. Bicarbonate solutions are hypertonic and may produce an undesirable rise in plasma sodium concentration in the process of correcting the metabolic acidosis. In cardiac arrest, however, the risks from acidosis exceed those of hypernatremia.

In less urgent forms of metabolic acidosis, Sodium Bicarbonate Injection, USP may be added to other intravenous fluids. The amount of bicarbonate to be given to older children and adults over a four-to-eight-hour period is approximately 2 to 5 mEq/kg of body weight – depending upon the severity of the acidosis as judged by the lowering of total CO2 content, blood pH and clinical condition of the patient. In metabolic acidosis associated with shock, therapy should be monitored by measuring blood gases, plasma osmolarity, arterial blood lactate, hemodynamics and cardiac rhythm. Bicarbonate therapy should always be planned in a stepwise fashion since the degree of response from a given dose is not precisely predictable. Initially an infusion of 2 to 5 mEq/kg body weight over a period of 4 to 8 hours will produce a measurable improvement in the abnormal acid-base status of the blood. The next step of therapy is dependent upon the clinical response of the patient. If severe symptoms have abated, then the frequency of administration and the size of the dose may be reduced.

In general, it is unwise to attempt full correction of a low total CO2 content during the first 24 hours of therapy, since this may be accompanied by an unrecognized alkalosis because of a delay in the readjustment of ventilation to normal. Owing to this lag, the achievement of total CO2 content of about 20 mEq/liter at the end of the first day of therapy will usually be associated with a normal blood pH. Further modification of the acidosis to completely normal values usually occurs in the presence of normal kidney function when and if the cause of the acidosis can be controlled. Values for total CO2 which are brought to normal or above normal within the first day of therapy are very likely to be associated with grossly alkaline values for blood pH, with ensuing undesired side effects.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Before using sodium bicarbonate medication

In deciding to use sodium bicarbonate medication, the risks of taking sodium bicarbonate medication must be weighed against the good it will do. This is a decision you and your doctor will make. For sodium bicarbonate medication, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children

Antacids should not be given to young children (up to 6 years of age) unless prescribed by a physician. This medicine may not help and may even worsen some conditions, so make sure that your child’s problem should be treated with this medicine before you use it.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of sodium bicarbonate in the elderly with use in other age groups.

Pregnancy

Pregnancy Category C (all Trimesters): Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

It is not known whether sodium bicarbonate will harm an unborn baby. However, sodium bicarbonate can cause fluid to build up in your body, which may be dangerous during pregnancy. DO NOT use sodium bicarbonate without a doctor’s advice if you are pregnant.

Breastfeeding

It is not known whether sodium bicarbonate passes into breast milk or if it could harm a nursing baby. Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding. However, do not use sodium bicarbonate without a doctor’s advice if you are breast-feeding a baby.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using sodium bicarbonate medication with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acalabrutinib
• Amphetamine
• Benzphetamine
• Dextroamphetamine
• Digoxin
• Elvitegravir
• Gefitinib
• Ketoconazole
• Ledipasvir
• Lisdexamfetamine
• Mefenamic Acid
• Memantine
• Methamphetamine
• Pazopanib
• Rilpivirine

Sodium bicarbonate interactions ¹

• Concurrent use of citrates with sodium bicarbonate may promote the development of calcium stones in patients with uric acid stones, due to sodium ion opposition to the hypocalciuric effect of the alkaline load; may also cause hypernatremia.
• Alkalinization of the urine may reduce the solubility of ciprofloxacin, norfloxacin, or ofloxacin in the urine; patients should be observed for signs of crystalluria and nephrotoxicity.
• Antacids may alkalinize the urine and counteract the effect of urinary acidifiers such as ammonium chloride, ascorbic acid and potassium or sodium phosphates; frequent use of antacids, especially in high doses, is best avoided by patients receiving therapy to acidify the urine.
• Alkalinization of the urine caused by sodium bicarbonate may reduce the effectiveness of methenamine by inhibiting its conversion to formaldehyde; concurrent use is not recommended.
• Concurrent and prolonged use /of calcium-containing preparations or milk or milk products with sodium bicarbonate may result in the milk-alkali syndrome.
• Concurrent use of anticholinergics or other medications with anticholinergic action with sodium bicarbonate may decrease absorption, reducing the effectiveness of the anticholinergic; doses of these medications should be spaced 1 hour apart from doses of sodium bicarbonate; also, urinary excretion may be delayed by alkalinization of the urine, thus potentiating the side effects of the anticholinergic.
• Urinary excretion may be inhibited when these medications amphetamines or quinidine are used concurrently with sodium bicarbonate, possibly resulting in toxicity; dosage adjustment may be needed when sodium bicarbonate therapy is initiated or discontinued or if dosage is changed.
• Absorption may be decreased when oral tetracyclines are used concurrently with sodium bicarbonate because of increase in intragastric pH; patients should be advised not to take sodium bicarbonate within 1 to 2 hours of tetracyclines.
• Concurrent use of sucralfate with sodium bicarbonate may be indicated in the treatment of duodenal ulcer to relieve pain; however, simultaneous administration is not recommended since antacids, such as sodium bicarbonate, may interfere with binding of sucralfate to the mucosa; patients should be advised not to take sodium bicarbonate within one-half hour before or 1 hour after sucralfate.
• Marked alkalinization of the urine caused by sodium bicarbonate may retard renal excretion of mexiletine.
• Alkalinization of the urine caused by sodium bicarbonate slows excretion and prolongs the effects of mecamylamine; concurrent use is not recommended.
• Sodium bicarbonate enhances lithium excretion, possibly resulting in decreased efficacy; this may be partly due to the sodium content.
• Sodium bicarbonate may cause increased gastrointestinal pH; concurrent administration of ketoconazole with sodium bicarbonate may result in a marked reduction in absorption of ketoconazole; patients should take sodium bicarbonate at least 2 hours after ketoconazole.
• Absorption may be decreased when oral iron supplements or preparations are used concurrently with antacids containing carbonate; because of the formation of less soluble complexes, iron supplements should not be taken within 1 hour before or 2 hours after sodium bicarbonate.
• Concurrent use of cimetidine, famotidine, nizatidine, or ranitidine with sodium bicarbonate may be indicated in the treatment of peptic ulcer to relieve pain; however, simultaneous administration of antacids of medium to high potency (80 mmol to 150 mmol HCl) is not recommended since absorption of these medications may be decreased; patients should be advised not to take any antacids within one-half to 1 hour of histamine H 2-receptor antagonists.
• Urine alkalinization induced by sodium bicarbonate may increase the half life of ephedrine and prolong its duration of action, especially if the urine remains alkaline for several days or longer; dosage adjustment of ephedrine may be necessary.
• Itraconazole concentration decreased by simultaneous antacids administration which decrease gastric acidity ².
• Renal tubular acidosis induced by maleic acid causes diuresis that results in increased excretion of sodium bicarbonate, glucose, phosphate, amino acids, and chloride. Based on the effects of maleic acid on mitochondrial energy metabolism and cellular ATP levels, the principal transport abnormality identified by microperfusion of rat proximal tubule bicarbonate transport was impaired basolateral membrane-active sodium transport ³.
• Serum sodium bicarbonate levels are often depressed /in ethylene glycol poisoning ⁴.

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Appendicitis or
• Intestinal or rectal bleeding—Oral forms of sodium bicarbonate may make these conditions worse:
• Edema (swelling of feet or lower legs) or
• Heart disease or
• High blood pressure (hypertension) or
• Kidney disease or
• Liver disease or
• Problems with urination or
• Toxemia of pregnancy—Sodium bicarbonate may cause the body to retain (keep) water, which may make these conditions worse

Who may not be able to take sodium bicarbonate

Antacids are safe for most people to take, although they aren’t suitable for everyone.

Speak to a pharmacist or your doctor for advice first if you:

• are pregnant or breastfeeding – most sodium bicarbonate are considered safe to take while pregnant or breastfeeding, but always get advice first
• are looking for a medicine for a child under 12 years of age – some antacids are not recommended for children
• have liver disease, kidney disease or heart failure – sodium bicarbonate may not be safe if you have one of these problems
• have an illness that means you need to control how much salt (sodium) is in your diet, such as high blood pressure or cirrhosis (liver scarring) – sodium bicarbonate contains high levels of sodium, which could make you unwell
• are taking other medicines – sodium bicarbonate can interfere with other medications and may need be avoided or taken at a different time.

What is sodium bicarbonate used for

Sodium bicarbonate (NaHCO₃) may help if you have:

• indigestion
• heartburn or acid reflux – also known as gastro-esophageal reflux disease (GERD)
• a stomach ulcer
• gastritis (inflammation of the stomach lining)

They can quickly relieve your symptoms for a few hours. But they don’t treat the underlying cause and long-term use isn’t recommended.

Speak to your doctor if you find you need to take antacids regularly.

Sodium bicarbonate uses

For safe and effective use of sodium bicarbonate:

• Follow your doctor’s instructions if this medicine was prescribed.
• Follow the manufacturer’s package directions if you are treating yourself.

For patients taking this medicine for a stomach ulcer:

• Take it exactly as directed and for the full time of treatment as ordered by your doctor, to obtain maximum relief of your symptoms.
• Take it 1 and 3 hours after meals and at bedtime for best results, unless otherwise directed by your doctor.

Sodium bicarbonate dosage

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For sodium bicarbonate effervescent powder

To relieve heartburn or sour stomach:

• Adults and teenagers—3.9 to 10 grams (1 to 2½ teaspoonfuls) in a glass of cold water after meals. However, the dose is usually not more than 19.5 grams (5 teaspoonfuls) a day.
• Children up to 6 years of age—Dose must be determined by your doctor.
• Children 6 to 12 years of age—1 to 1.9 grams (¼ to ½ teaspoonful) in a glass of cold water after meals.

For sodium bicarbonate powder

To relieve heartburn or sour stomach:

• Adults and teenagers—One-half teaspoonful in a glass of water every two hours. Your doctor may change the dose if needed.
• Children—Dose must be determined by your doctor.

To make the urine more alkaline (less acidic):

• Adults and teenagers—One teaspoonful in a glass of water every four hours. Your doctor may change the dose if needed. However, the dose is usually not more than 4 teaspoonfuls a day.
• Children—Dose must be determined by your doctor.

For sodium bicarbonate tablets

To relieve heartburn or sour stomach:

• Adults and teenagers—325 milligrams (mg) to 2 grams one to four times a day.
• Children up to 6 years of age—Dose must be determined by your doctor.
• Children 6 to 12 years of age—The dose is 520 mg. The dose may be repeated in thirty minutes.

To make the urine more alkaline (less acidic):

• Adults and teenagers—At first, four grams, then 1 to 2 grams every four hours. However, the dose is usually not more than 16 grams a day.
• Children—The dose is based on body weight and must be determined by your doctor. The usual dose is 23 to 230 mg per kilogram (kg) (10.5 to 105 mg per pound) of body weight a day. Your doctor may change the dose if needed.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Usual Adult Dose for Metabolic Acidosis

Parenteral:
If acid-base status is available, dosages should be calculated as follows: 0.2 x weight (kg) x base deficit.

Alternatively:

HCO3 (mEq) required = 0.5 x weight (kg) x [24 – serum HCO3 (mEq/L)].

or

Moderate metabolic acidosis: 50 to 150 mEq sodium bicarbonate diluted in 1 L of D5W to be intravenously infused at a rate of 1 to 1.5 L/hour during the first hour.

Severe metabolic acidosis: 90 to 180 mEq sodium bicarbonate diluted in 1 L of D5W to be intravenously infused at a rate of 1 to 1.5 L/hour during the first hour.

If acid-base status is not available, dosages should be calculated as follows: 2 to 5 mEq/kg IV infusion over 4 to 8 hours; subsequent doses should be based on patient’s acid-base status.

Oral:

Moderate metabolic acidosis: 325 to 2000 mg orally 1 to 4 times a day. One gram provides 11.9 mEq (mmoL) each of sodium and bicarbonate.

Usual Adult Dose for Diabetic Ketoacidosis

Although sodium bicarbonate is approved for the treatment of metabolic acidosis, data have shown that the use of this drug may be harmful in certain clinical settings such as lactic acidosis, acidosis with tissue hypoxia, uremia, severe cardiac dysfunction or arrest, and diabetic ketoacidosis.

Most experts only allow for its use when tissue perfusion and ventilation are maximized and the arterial pH is 7.1 or lower.

If sodium bicarbonate is used to treat diabetic ketoacidosis, the initial dosage is 50 mEq sodium bicarbonate in 1 L of appropriate IV solution to be given once.

Insulin therapy may obviate the need for bicarbonate therapy since it will promote glucose utilization and decrease the production of ketoacids.

Usual Adult Dose for Urinary Alkalinization

Parenteral:

50 to 150 mEq sodium bicarbonate diluted in 1 L of D5W to be intravenously infused at a rate of 1 to 1.5 L/hour.

Oral:

325 to 2000 mg orally 1 to 4 times a day. One gram provides 11.9 mEq (mmoL) each of sodium and bicarbonate.

The goal of therapy is to correct serum pH and increase the urinary pH to 8 in order to increase the renal excretion of toxic substances such as salicylates or lithium.

If the increase in urinary pH is inadequate, increasing the sodium bicarbonate in solution to 100 to 150 mEq/L may result in further alkalinization of the urine.

Usual Adult Dose for Dyspepsia

325 to 2000 mg orally 1 to 4 times a day.

Usual Adult Dose for Hyperkalemia

One ampule of 7.5% sodium bicarbonate (44.6 mEq HCO3 ion) may be administered slowly IV over 5 minutes and repeated at 10 to 15 minute intervals if ECG changes persist. The onset of action occurs within 30 minutes and the effect lasts for 1 to 2 hours. The resultant effect restores intracellular potassium levels to normal without decreasing total body potassium stores.

Circulatory overload and hypernatremia can occur when large volumes of hypertonic sodium bicarbonate are given. If hypocalcemia is present, seizures and tetany may occur as blood pH rises and the ionized free calcium decreases; hence, calcium should be given first. Hyponatremia will magnify the cardiac effects of hyperkalemia, and sodium bicarbonate can be used to treat this as well.

Usual Adult Dose for Asystole

1 mEq/kg slow IV initially, may repeat with 0.5 mEq/kg 10 minutes later one time, or as indicated by the patient’s acid-base status.

Usual Pediatric Dose for Metabolic Acidosis

If acid-base status is available, dosages should be calculated as follows:
Infants and Children: HCO3 (mEq) required = 0.3 x weight (kg) x base deficit (mEq/L) OR HCO3 (mEq) required = 0.5 x weight (kg) x [24 – serum HCO3 (mEq/L)].

If acid-base status is not available, dosages should be calculated as follows:

Older children: 2 to 5 mEq/kg IV infusion over 4 to 8 hours; subsequent doses should be based on patient acid-base status.

Usual Pediatric Dose for Urinary Alkalinization

0 to 12 years: 1 to 10 mEq (84 to 840 mg)/kg/day orally in divided doses; dose should be titrated to desired urinary pH.

Greater than 12 to 18 years: 325 to 2000 mg orally 1 to 4 times a day. One gram provides 11.9 mEq (mmol) each of sodium and bicarbonate.

The goal of therapy is to correct serum pH and increase the urinary pH to 8 in order to increase the renal excretion of toxic substances such as salicylates or lithium.

If the increase in urinary pH is inadequate, increasing the sodium bicarbonate in solution to 100 to 150 mEq/L may result in further alkalinization of the urine.

Usual Pediatric Dose for Hyperuricemia Secondary to Chemotherapy

0 to 12 years:

Parenteral:
120 to 200 mEq/m2/day diluted in maintenance IV fluids of 3000 mL/m2/day; titrate to maintain urine pH between 6 and 7.

Oral:
12 g/m2/day divided into 4 doses; titrate to maintain urine pH between 6 and 7.

Usual Pediatric Dose for Asystole

1 mEq/kg slow IV initially, may repeat with 0.5 mEq/kg 10 minutes later one time, or as indicated by the patient acid-base status.

Renal Dose Adjustments

Due to the risk of hypernatremia, electrolyte shifts, and systemic pH changes, it is recommended that sodium bicarbonate be used with caution due to this patient’s renal dysfunction. Close monitoring of this patient’s plasma electrolytes and bicarbonate is recommended, particularly if dose increments are considered.

Liver Dose Adjustments

Due to the risk of hypernatremia, electrolyte shifts, and systemic pH changes, it is recommended that sodium bicarbonate be used with caution due to the patient’s liver disease. Close monitoring of this patient’s plasma electrolytes and bicarbonate is recommended, particularly if dose increments are considered.

Dialysis

Sodium bicarbonate is removed by peritoneal dialysis. Bicarbonate has been commonly used in the peritoneal dialysate to raise the pH in patients in whom the standard pH of 5.5 causes abdominal discomfort on inflow.

Sodium bicarbonate is removed by hemodialysis. Bicarbonate has been commonly used in the dialysate bath to correct metabolic acidosis, and has been used preferentially over acetate for patients with marked hemodynamic instability due to sepsis or other causes, particularly patients requiring vasopressor support. Bicarbonate dialysate is also used for high-flux and high-efficiency dialysis with K/V greater than 5.5 mL/min/L.

Other Comments

A gradual rise in the plasma bicarbonate concentration up to the normal range over a 12 to 24 hour period is recommended as opposed to a rapid “correction” of the patient’s entire bicarbonate deficit. Rapid correction of the deficit can cause hypokalemic cardiotoxicity in patients who are potassium-depleted, tetany in patients with renal failure or hypocalcemia or congestive heart failure in patients with poor left ventricular function due to the excess sodium load from this medication). Other possible side effects include systemic alkalosis and/or CNS acidosis. Further bicarbonate therapy depends on the patient’s plasma bicarbonate level.

In patients with lactic acidosis, resolution of the event responsible for the acidosis is the primary treatment. While severe lactic acidosis can contribute to circulatory collapse, treatment with sodium bicarbonate may promote lactate production. In general, sodium bicarbonate may be beneficial if the plasma bicarbonate is less than 8 mEq/L or the systemic pH is less than 7.1.

How and when to take sodium bicarbonate

Check the instructions on the packet or leaflet to see how much sodium bicarbonate to take and how often. This depends on the reasons for taking sodium bicarbonate.

Sodium bicarbonate should be used when you have symptoms or think you will get them soon – for most people, the best time to take sodium bicarbonate is with or soon after meals, and just before going to bed.

Remember that doses for children may be lower than for adults.

How should I take sodium bicarbonate?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Sodium bicarbonate tablets are usually dissolved completely in water before swallowing. Follow al directions on the product label.

Call your doctor if your symptoms do not improve, or if they get worse while using sodium bicarbonate.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Since sodium bicarbonate is used when needed, you may not be on a dosing schedule. Do not take more of this medicine than recommended on the product label.

What should I avoid while taking sodium bicarbonate?

Avoid taking this medicine without a doctor’s advice if you regularly take other medicines.

Sodium bicarbonate side effects

Sodium bicarbonate is an extremely well-known agent that historically has been used for a variety of medical conditions. Despite the widespread use of oral bicarbonate, little documented toxicity has occurred, and the emergency medicine literature contains no reports of toxicity caused by the ingestion of baking soda. Risks of acute and chronic oral bicarbonate ingestion include metabolic alkalosis, hypernatremia, hypertension, gastric rupture, hyporeninemia, hypokalemia, hypochloremia, intravascular volume depletion, and urinary alkalinization. Abrupt cessation of chronic excessive bicarbonate ingestion may result in hyperkalemia, hypoaldosteronism, volume contraction, and disruption of calcium and phosphorus metabolism ⁵.

Sodium bicarbonate don’t usually have many side effects if they’re only taken occasionally and at the recommended dose.

Common side effects may include:

• dry mouth;
• increased thirst; or
• urinating more than usual.

But sometimes sodium bicarbonate can cause:

• diarrhea or constipation
• flatulence (wind)
• stomach cramps
• feeling sick or vomiting

These should pass once you stop taking sodium bicarbonate medicine.

Check with your doctor as soon as possible if any of the following side effects occur while taking sodium bicarbonate:

• frequent urge to urinate
• headache (continuing)
• loss of appetite (continuing)
• mood or mental changes
• muscle pain or twitching
• nausea or vomiting
• nervousness or restlessness
• slow breathing
• swelling of feet or lower legs
• unpleasant taste
• unusual tiredness or weakness

Some side effects of sodium bicarbonate may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less Common

• Increased thirst
• stomach cramps

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Speak to a pharmacist or your doctor if they don’t improve or are troublesome. You may need to switch to another medicine.

• Volume expansion can increase blood pressure and promote edema, so that use of even moderate amt of sodium bicarbonate may be hazardous to persons with renal insufficiency or incipient or active hypertension or cardiac failure ⁶.
• Sodium bicarbonate should be used with extreme caution in patients with congestive heart failure or other edematous or sodium-retaining conditions; in patients with renal insufficiency, especially those with severe insufficiency such as oliguria or anuria ⁷.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using sodium bicarbonate and call your doctor at once if you have:

• severe stomach pain;
• swelling, rapid weight gain; or
• shortness of breath (even with mild exertion).

Metabolic

Chronic ingestion of bicarbonate may rarely cause intravascular volume expansion with resultant hyporeninemia and hypoaldosteronemia. In this rare circumstance, the serum potassium may be elevated.

Rare cases of sodium bicarbonate abuse have been associated with features of Munchausen syndrome. These patients often present with an otherwise unexplained hypokalemic hypochloremic metabolic alkalosis.

Hypernatremia may cause water retention, weight gain, and edema, which may be important in some patients with congestive heart failure, renal insufficiency, or severe liver disease.

Metabolic side effects have included metabolic alkalosis, hypernatremia/hyperosmolarity, hypochloremia, and hypokalemia. These effects have been associated with rapid or prolonged administration. Side effects have rarely included intravascular volume expansion with resultant hyporeninemia and hypoaldosteronemia.

Respiratory

The respiratory drive may be suppressed after bicarbonate administration due to increased venous C02 concentration. Without adequate ventilation, worsened systemic acidosis could develop.

Respiratory side effects have included suppressed respiratory drive.

Nervous system

Rapid infusion of hyperosmolar sodium bicarbonate has been associated with intraventricular hemorrhage in the pediatric literature.

Irritability and tetany have been associated with sodium bicarbonate-induced alkalosis or hypernatremia.

Due to greater permeability of the blood-brain barrier to hydrogen than to bicarbonate, the pH of cerebrospinal fluid may significantly decrease during sodium bicarbonate administration, which can cause mental stupor or coma.

Nervous system side effects have included irritability, tetany, mental stupor, coma, and intraventricular hemorrhage.

Local side effects

Local side effects have included IV site pain, venous irritation, and extravasation. Cellulitis, tissue necrosis, ulceration, or skin sloughing have possibly been the result of extravasation. A slow rate of administration of a properly diluted solution into a large bore needle and vein is recommended if IV administration is necessary.

Cardiovascular

Cardiovascular side effects have included decreased cardiac contractility possibly resulting from infusion of sodium bicarbonate in patients with severe acidosis.

Experimentally, the administration of intravenous hypertonic sodium bicarbonate has been associated with increased serum osmolality, decreased ionized serum calcium (which is associated with decreased myocardial contractility), and peripheral vasodilation. Some experts recommend invasive hemodynamic monitoring in acidotic patients before the administration of bicarbonate.

Gastrointestinal

Gastrointestinal side effects associated with oral administration have rarely included gastric rupture.

As an antacid, sodium bicarbonate, especially after excess food or liquid, can cause excess gas release (when combined with gastric acid). The mortality associated with gastric rupture is as high as 65%.

Renal

Urinary alkalinization from bicarbonate can cause a falsely positive colorimetric assay for protein.

Renal side effects have rarely included “False proteinuria”.

Human Toxicity Reports

With a combination of 380 milliequivalent (mEq) of sodium bicarbonate and 640 mEq of calcium carbonate/day only 10% of 1350 patients developed alkalosis ⁸. Daily doses up to 25 milliequivalent (mEq)/kg /were administered/ to patients for 3 weeks. Changes in plasma electrolyte concentration were not remarkable; plasma total carbon dioxide increased by only 5 mEq/L with largest dose. Considerable weight gain was most prominent effect ⁸.

In neutralizing gastric acid, distention and possible damage or rupture of the stomach may occur from carbon dioxide release ⁹.

When large doses of sodium bicarbonate (NaHCO₃) and/or calcium bicarbonate (CaHCO₃) were administered with milk or cream for the management of peptic ulcer, the milk-alkali syndrome occurred frequently. This syndrome results from large quantities of Ca²+ and absorbable alkali; effects consist of hypercalcemia, reduced secretion of parathyroid hormone, retention of phosphate, precipitation of Ca²+ salts in the kidney, and renal insufficiency. Therapeutic regimens emphasizing the use of dairy products seldom are employed in current practice ¹⁰.

Large doses of sodium bicarbonate (NaHCO₃), particularly in patients with renal insufficiency, have produced systemic alkalosis and/or an expansion in the extracellular fluid volume with edema. Frank hypocalcemic tetany accompanied by hypoglycemia has occurred in 9-yr old girl ⁹.

A case of baking soda pica in a woman at 31 weeks of pregnancy causing severe hypokalemic metabolic alkalosis and rhabdomyolysis was reported ¹¹. A multigravida at 31 weeks of gestation presented with weakness and muscle pain. She was found to have severe hypokalemic metabolic alkalosis and rhabdomyolysis, with elevation in serum transaminases and hypertension. It was initially thought the patient had an atypical presentation of preeclampsia until it was realized that she was ingesting 1 full box of baking soda (454 g sodium bicarbonate) per day ¹¹. Symptoms and abnormal laboratory findings resolved with discontinuation of the patient’s pica practices. Pica is a common but often overlooked practice that can potentially lead to life-threatening disorders. A thorough evaluation of a patient’s dietary intake is extremely important, especially in the setting of atypical presentations of disease in pregnancy.

The anticoagulant effects of sodium bicarbonate was investigated in fresh human whole blood obtained from normal healthy volunteers. Prothrombin and thrombin clotting time determination indicated that bicarbonate can interfere with the clotting process ¹².

Sodium bicarbonate hazards

Reactivity Alerts

none

Air & Water Reactions

Stable in dry air, but slowly decomposes in moist air. Moderately water soluble. Decomposes slowly in water (accelerated by agitation) ¹³.

Fire Hazard

Literature sources indicate that this chemical is noncombustible ¹³.

Health Hazard

Symptoms of exposure to this compound include irritation of the skin, eyes, nose and throat, coughing, chest discomfort and gastrointestinal disturbance. It may cause distention or rupture of the stomach, systemic alkalosis, edema and expansion of extracellular fluid volume. Severe alkalosis may be characterized by hyperirritability and tetany. It can cause cerebral edema leading to death. It may also cause renal injury.

When heated to decomposition this compound emits toxic fumes of carbon monoxide, carbon dioxide and sodium oxides ¹³.

Reactivity Profile

Sodium bicarbonate (NaHCO₃) reacts exothermically with acids to generate non-toxic carbon dioxide gas. Decomposes when heated. Incompatible with acids, acidic salts (dopamine hydrochloride, pentazocine lactate, many alkaloidal salts) aspirin and bismuth salicylate.

First Aid

EYES: First check the victim for contact lenses and remove if present. Flush victim’s eyes with water or normal saline solution for 20 to 30 minutes while simultaneously calling a hospital or poison control center. Do not put any ointments, oils, or medication in the victim’s eyes without specific instructions from a physician. IMMEDIATELY transport the victim after flushing eyes to a hospital even if no symptoms (such as redness or irritation) develop.

SKIN: IMMEDIATELY flood affected skin with water while removing and isolating all contaminated clothing. Gently wash all affected skin areas thoroughly with soap and water. If symptoms such as redness or irritation develop, IMMEDIATELY call a physician and be prepared to transport the victim to a hospital for treatment.

INHALATION: IMMEDIATELY leave the contaminated area; take deep breaths of fresh air. If symptoms (such as wheezing, coughing, shortness of breath, or burning in the mouth, throat, or chest) develop, call a physician and be prepared to transport the victim to a hospital. Provide proper respiratory protection to rescuers entering an unknown atmosphere. Whenever possible, Self-Contained Breathing Apparatus (SCBA) should be used; if not available, use a level of protection greater than or equal to that advised under Protective Clothing.

INGESTION: If the victim is conscious and not convulsing, give 1 or 2 glasses of water to dilute the chemical and IMMEDIATELY call a hospital or poison control center. Be prepared to transport the victim to a hospital if advised by a physician. If the victim is convulsing or unconscious, do not give anything by mouth, ensure that the victim’s airway is open and lay the victim on his/her side with the head lower than the body. DO NOT INDUCE VOMITING. IMMEDIATELY transport the victim to a hospital.

1. Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006.[↩]
2. Hardman, J.G., L.E. Limbird, P.B., A.G. Gilman. Goodman and Gilman’s The Pharmacological Basis of Therapeutics. 10th ed. New York, NY: McGraw-Hill, 2001., p. 1303[↩]
3. Bingham, E.; Cohrssen, B.; Powell, C.H.; Patty’s Toxicology Volumes 1-9 5th ed. John Wiley & Sons. New York, N.Y. (2001)., p. 5:842[↩]
4. Bingham, E.; Cohrssen, B.; Powell, C.H.; Patty’s Toxicology Volumes 1-9 5th ed. John Wiley & Sons. New York, N.Y. (2001)., p. 7:8[↩]
5. Thomas SH, Stone CK; Am J Emerg Med 12 (1): 57-9; 1994[↩]
6. Goodman, L.S., and A. Gilman. (eds.) The Pharmacological Basis of Therapeutics. 5th ed. New York: Macmillan Publishing Co., Inc., 1975., p. 966[↩]
7. McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 2590[↩]
8. Gilman, A. G., L. S. Goodman, and A. Gilman. (eds.). Goodman and Gilman’s The Pharmacological Basis of Therapeutics. 6th ed. New York: Macmillan Publishing Co., Inc. 1980., p. 994[↩][↩]
9. Gosselin, R.E., R.P. Smith, H.C. Hodge. Clinical Toxicology of Commercial Products. 5th ed. Baltimore: Williams and Wilkins, 1984., p. II-125[↩][↩]
10. Hardman, J.G., L.E. Limbird, P.B., A.G. Gilman. Goodman and Gilman’s The Pharmacological Basis of Therapeutics. 10th ed. New York, NY: McGraw-Hill, 2001., p. 1013[↩]
11. Grotegut CA et al; Obstet Gynecol 107 (2 Pt 2) 484-6;2006[↩][↩]
12. Wong DW et al; J Am Med Assoc 244 (1): 61; 1980[↩]
13. The National Toxicology Program. https://ntp.niehs.nih.gov/[↩][↩][↩]

What is ranitidine

Ranitidine is a class of medications called histamine-2 blockers (H2 blockers) and ranitidine works by reducing the amount of acid your stomach produces. Ranitidine is used to treat and prevent ulcers in the stomach and intestines. Ranitidine also treats conditions in which the stomach produces too much acid, such as Zollinger-Ellison syndrome. Ranitidine also treats gastroesophageal reflux disease (GERD) and other conditions in which acid backs up from the stomach into the esophagus, causing heartburn and injury of the food pipe (esophagus).

Over-the-counter ranitidine is used to prevent and treat symptoms of heartburn associated with acid indigestion and sour stomach.

Ranitidine comes as tablets, soluble (dispersible) tablets that dissolve in water to make a drink, or as a liquid that you drink.

All types of ranitidine are available on prescription. You can also buy the lowest strength 75mg tablets from pharmacies and supermarkets.

Key facts

• It’s usual to take ranitidine once or twice a day.
• Some people only need to take ranitidine for a short time, when they have symptoms. Others need to take it for longer.
• You can take ranitidine with or without food.
• It’s unusual to get any side effects. However, some people may get stomach pain or constipation, or feel sick (nausea). This tends to get better as you carry on taking ranitidine.
• Ranitidine is called by the brand names Zantac, Zantac 75, Zantac EFFERdose, Zantac Syrup and Taladine

Ranitidine mechanism of action

Ranitidine is a histamine-2 antagonist or H2 blocker. Ranitidine works by reducing the amount of acid your stomach produces. Histamine is a chemical that occurs naturally in your body. Histamine encourages your stomach to produce acid which it needs to digest your food. By blocking the histamine, ranitidine reduces the amount of acid your stomach produces. Having less acid in your stomach allows ulcers and inflammation to heal. If your foodpipe (esophagus) has been damaged by stomach acid, this will also have a chance to heal.

Before taking ranitidine – Precautions

• tell your doctor and pharmacist if you are allergic to ranitidine or any other medications.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention either of the following: anticoagulants (‘blood thinners’) such as warfarin (Coumadin); and triazolam (Halcion). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had porphyria, phenylketonuria, or kidney or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking ranitidine, call your doctor.
• Using ranitidine may increase your risk of developing pneumonia. Symptoms of pneumonia include chest pain, fever, feeling short of breath, and coughing up green or yellow mucus. Talk with your doctor about your specific risk of developing pneumonia.

How much ranitidine is safe to take?

Ranitidine comes as a tablet, an effervescent tablet, effervescent granules, and a syrup to take by mouth. Each tablet contains 75mg, 150mg or 300mg of ranitidine. You can buy 75mg tablets in pharmacies and supermarkets. Soluble tablets, and 150mg and 300mg tablets are only available on prescription.

Ranitidine is usually taken once a day at bedtime or two to four times a day. Over-the-counter ranitidine comes as a tablet to take by mouth. It is usually taken once or twice a day. To prevent symptoms, it is taken 30 to 60 minutes before eating or drinking foods that cause heartburn. Follow the directions on your prescription or the package label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take ranitidine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Dissolve ranitidine effervescent tablets and granules in a full glass (6 to 8 ounces [180 to 240 milliliters]) of water before drinking.

Do not take over-the-counter ranitidine for longer than 2 weeks unless your doctor tells you to. If symptoms of heartburn, acid indigestion, or sour stomach last longer than 2 weeks, stop taking ranitidine and call your doctor.

The usual dose to treat:

• indigestion or heartburn is 75mg to 300mg ranitidine a day
• stomach ulcers and inflammation of the food pipe is 300mg to 600mg ranitidine a day
• Zollinger-Ellison syndrome is 450mg to 6 grams ranitidine a day

Ranitidine liquid comes in 2 different strengths – your daily dose will depend on what your doctor prescribes. Follow your doctor’s advice about how much ranitidine to take and when.

• Doses are usually lower for children and people with kidney problems.

If a doctor prescribes ranitidine for your child, they will use your child’s weight or age to work out the right dose.

How long does ranitidine take to work

Your indigestion and heartburn should start to feel better within 1 or 2 hours. The effects will usually last for around 12 hours.

It may take a few weeks for ranitidine to work properly. Depending on your problems, you may still have some acid symptoms during this time.

If you’re taking ranitidine to prevent stomach ulcers, however, you may not feel any different. Carry on taking your medicine. It will still be working.

How long will I take ranitidine for?

If you’re taking lower strength ranitidine (75mg) that you bought from a pharmacy or supermarket, speak to a pharmacist or doctor before starting on a second packet. They may recommend tests to find out what’s causing your symptoms, if taking ranitidine hasn’t cleared them up.

If your doctor prescribes ranitidine for you, you may only need to take it for a few weeks or months, depending on your health problem. Sometimes you might need to take it for longer.

Your doctor may suggest taking ranitidine only when you have symptoms. This means you won’t have to take it every day. Once you feel better, you can stop taking it – often after a few days or weeks.

Taking ranitidine this way isn’t suitable for everyone. Speak to your doctor about what’s best for you.

Although ranitidine appears to only minimally affect the secretion of gastric intrinsic factor, malabsorption of, and resultant deficiency in vitamin B12 may occur during long-term ranitidine therapy ¹.

Is it safe to take ranitidine every day?

It’s usually best to take ranitidine for a short time. You might take it for a month or two, for example, until your stomach heals. Some people may take it every now and again when they have symptoms. You may find that ranitidine stops working and your symptoms come back if you take it for longer than this.

If you’re taking ranitidine to treat Zollinger Ellison syndrome or another long term problem, however, you may need to take it for longer. In this case, follow your doctor’s instructions about the best way to take it.

Are there similar medicines to ranitidine?

There are 3 other medicines that are similar to ranitidine. They are cimetidine, famotidine and nizatidine.

Like ranitidine, these medicines are H2 blockers. They work in the same way as ranitidine to reduce the amount of acid in your stomach.

Famotidine and nizatidine generally work as well as ranitidine and have similar side effects. However they may suit some people better.

Cimetidine can interfere with lots of medicines and has more side effects than other H2 blockers.

Are there other indigestion medicines?

Yes there are other pharmacy and prescription medicines for indigestion and heartburn.

Antacids, like calcium carbonate (Tums or Mylanta), sodium bicarbonate (Neut), Maalox and Milk of Magnesia, relieve indigestion and heartburn by neutralizing the acid in your stomach. They give quick relief that lasts for a few hours. They’re ideal for occasional stomach acid symptoms.

Some antacids, such as Gaviscon, have an extra ingredient called alginic acid. They work by lining your stomach so that juices from it don’t splash up into your foodpipe. They’re especially good for relieving acid reflux.

Antacids are available from pharmacies and supermarkets.

Proton pump inhibitors (PPIs) reduce the amount of acid made in your stomach, but they do this in a different way to H2 blockers.

They include esomeprazole (Nexium), lansoprazole (Zoton FasTabs), omeprazole (Losec), pantoprazole (Pantoloc Control) and rabeprazole (Pariet).

In general, proton pump inhibitors (PPIs) are used first because they are better than H2 blockers at reducing stomach acid. Your doctor may prescribe an H2 blocker if you don’t get on with a proton pump inhibitor (PPI) – for example because of the side effects.

Lansoprazole and rabeprazole are only available on prescription but you can buy omeprazole, esomeprazole and pantoprazole directly from pharmacies. You can also buy esomeprazole from supermarkets.

Can I take ranitidine with other indigestion medicines?

Some antacids are okay to take at the same time as ranitidine. Other antacids, such as Gaviscon, need to be taken a certain amount of time before or after you take the ranitidine. Check the instructions on the packet to see how long you need to wait between medicines.

Sometimes, depending on your symptoms, your doctor may prescribe an H2 blocker as well as a proton pump inhibitor. This will often be for a short time and you’ll usually take the H2 blocker at night.

If you’re prescribed sucralfate (a medicine to treat ulcers), take it at least 2 hours after ranitidine. This is because sucralfate can stop your body from properly absorbing the ranitidine.

Can I drive or ride a bike after taking ranitidine?

Occasionally, ranitidine can make you feel dizzy or sleepy, or give you blurred vision. If this happens to you, don’t drive, cycle or use machinery or tools until you feel better.

Furthermore, the amount of alcohol contained in a large dose of ranitidine liquid may affect your ability to drive or operate machines. In this case, do not attempt to drive or use any machinery.

Can I drink alcohol with ranitidine?

Yes, you can drink alcohol with ranitidine but be aware that ranitidine liquid also contains a small amount of alcohol.

Also, drinking alcohol makes your stomach produce more acid than normal. This can irritate your stomach lining and make your symptoms worse.

Is there any food or drink I need to avoid?

You can eat and drink normally while taking ranitidine.

However, it’s best to avoid foods that seem to make your indigestion worse, such as rich, spicy and fatty foods. You may also want to cut down on caffeinated drinks, such as tea, coffee and cola, as well as alcohol.

Can lifestyle changes help?

It may be possible to ease symptoms caused by too much stomach acid by making a few changes to your diet and lifestyle:

• lose excess weight
• don’t eat foods that can make your symptoms worse, such as rich, spicy and fatty foods, and acidic foods like tomatoes, citrus fruits, salad dressings and fizzy drinks
• cut down on caffeinated drinks, such as tea, coffee and cola, as well as alcohol and smoking
• if you have symptoms at night, try not to eat for at least 3 hours before you go to bed
• raise the head of your bed by 10 to 20cm, so your head and chest are higher than your waist

Who can and can’t take ranitidine

Ranitidine can be taken by adults. It can also be given to children under 16 years of age on prescription.

Ranitidine isn’t suitable for some people. To make sure that it is safe for you, tell your doctor if you:

• have had an allergic reaction to ranitidine or any other medicines in the past
• have kidney problems
• have an intolerance to, or cannot absorb, some sugars such as fructose
• have been advised to eat a low calcium or low salt diet
• cannot have alcohol – ranitidine liquid contains a small amount of alcohol
• have phenylketonuria (PKU), a rare inherited illness

If you’re due to have an endoscopy to find out what’s causing your symptoms, stop taking ranitidine at least 2 weeks before your procedure. This is because ranitidine may hide some of the problems that would usually be spotted during an endoscopy.

Pediatric Use

The safety and effectiveness of ranitidine have been established in the age-group of 1 month to 16 years for the treatment of duodenal and gastric ulcers, gastroesophageal reflux disease and erosive esophagitis, and the maintenance of healed duodenal and gastric ulcer. Use of ranitidine in this age-group is supported by adequate and well-controlled trials in adults, as well as additional pharmacokinetic data in pediatric patients and an analysis of the published literature.

Safety and effectiveness in pediatric patients for the treatment of pathological hypersecretory conditions or the maintenance of healing of erosive esophagitis have not been established.

Safety and effectiveness in neonates (aged younger than 1 month) have not been established.

Geriatric Use

Of the total number of subjects enrolled in US and foreign controlled clinical trials of oral formulations of ranitidine, for which there were subgroup analyses, 4,197 were aged 65 and older, while 899 were aged 75 and older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

This drug is known to be substantially excreted by the kidney and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, caution should be exercised in dose selection, and it may be useful to monitor renal function.

Pregnancy and breastfeeding

Tell your pharmacist or doctor if you’re trying to get pregnant, are already pregnant or if you’re breastfeeding.

Usually, ranitidine is safe to take during pregnancy and while breastfeeding. Animal models have failed to reveal evidence of impaired fertility or fetal harm. It is unknown whether use of gastric-suppressing drugs are associated with childhood allergy and asthma. There are no controlled data in human pregnancy.

If you’re pregnant, it’s always better to try to treat indigestion without taking a medicine.

Your doctor or midwife will first advise you to try to ease your symptoms by eating smaller meals more often, and not eating fatty and spicy foods. They may also suggest raising the head of your bed by 10 to 20cm, so your head and chest are higher than your waist. This will help stop stomach acid travelling up towards your throat.

If these lifestyle changes don’t work, you may be recommended a medicine like ranitidine.

Teratogenic Effects

Pregnancy Category B. Reproduction studies have been performed in rats and rabbits at doses up to 160 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to ranitidine. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Carcinogenesis, Mutagenesis, Impairment of Fertility

There was no indication of tumorigenic or carcinogenic effects in life-span studies in mice and rats at dosages up to 2,000 mg/kg/day.

Ranitidine was not mutagenic in standard bacterial tests (Salmonella, Escherichia coli) for mutagenicity at concentrations up to the maximum recommended for these assays.

In a dominant lethal assay, a single oral dose of 1,000 mg/kg to male rats was without effect on the outcome of 2 matings per week for the next 9 weeks.

Ranitidine and breastfeeding

Ranitidine is safe to take while you’re breastfeeding. It passes into breast milk, but only in small amounts which aren’t harmful to the baby.

However, if your baby is premature or has health problems check with your doctor first.

Cautions with other medicines

For safety, tell your pharmacist or doctor if you’re taking other medicines including herbal remedies, vitamins or supplements.

Some medicines can interfere with ranitidine and make you more likely to have side effects.

Tell your doctor if you’re taking these medicines before you start taking ranitidine:

• anti-fungal medicines such as itraconazole, ketoconazole or posaconazole
• any medicine used to treat cancer
• HIV medicines

Ranitidine has been reported to affect the bioavailability of other drugs through several different mechanisms such as competition for renal tubular secretion, alteration of gastric pH, and inhibition of cytochrome P450 enzymes.

Procainamide: Ranitidine, a substrate of the renal organic cation transport system, may affect the clearance of other drugs eliminated by this route. High doses of ranitidine (e.g., such as those used in the treatment of Zollinger-Ellison syndrome) have been shown to reduce the renal excretion of procainamide and N-acetylprocainamide resulting in increased plasma levels of these drugs. Although this interaction is unlikely to be clinically relevant at usual ranitidine doses, it may be prudent to monitor for procainamide toxicity when administered with oral ranitidine at a dose exceeding 300 mg per day.

Warfarin: There have been reports of altered prothrombin time among patients on concomitant warfarin and ranitidine therapy. Due to the narrow therapeutic index, close monitoring of increased or decreased prothrombin time is recommended during concurrent treatment with ranitidine.

Ranitidine may alter the absorption of drugs in which gastric pH is an important determinant of bioavailability. This can result in either an increase in absorption (e.g., triazolam, midazolam, glipizide) or a decrease in absorption (e.g., ketoconazole, atazanavir, delavirdine, gefitinib). Appropriate clinical monitoring is recommended.

Atazanavir: Atazanavir absorption may be impaired based on known interactions with other agents that increase gastric pH. Use with caution. See atazanavir label for specific recommendations.

Delavirdine: Delavirdine absorption may be impaired based on known interactions with other agents that increase gastric pH. Chronic use of H2-receptor antagonists with delavirdine is not recommended.

Gefitinib: Gefitinib exposure was reduced by 44% with the coadministration of ranitidine and sodium bicarbonate (dosed to maintain gastric pH above 5.0). Use with caution.

Glipizide: In diabetic patients, glipizide exposure was increased by 34% following a single 150-mg dose of oral ranitidine. Use appropriate clinical monitoring when initiating or discontinuing ranitidine.

Ketoconazole: Oral ketoconazole exposure was reduced by up to 95% when oral ranitidine was coadministered in a regimen to maintain a gastric pH of 6 or above. The degree of interaction with usual dose of ranitidine (150 mg twice daily) is unknown.

Midazolam: Oral midazolam exposure in 5 healthy volunteers was increased by up to 65% when administered with oral ranitidine at a dose of 150 mg twice daily. However, in another interaction trial in 8 volunteers receiving IV midazolam, a 300-mg oral dose of ranitidine increased midazolam exposure by about 9%. Monitor patients for excessive or prolonged sedation when ranitidine is coadministered with oral midazolam.

Triazolam: Triazolam exposure in healthy volunteers was increased by approximately 30% when administered with oral ranitidine at a dose of 150 mg twice daily. Monitor patients for excessive or prolonged sedation.

These are not all the medicines that may not mix well with ranitidine. For a full list see the leaflet inside your medicines packet.

Mixing ranitidine with herbal remedies and supplements

There isn’t enough research to know if complementary medicines and herbal remedies are safe to take with ranitidine.

What is ranitidine used for

Ranitidine is used to treat and prevent ulcers in the stomach and intestines. Ranitidine also treats conditions in which the stomach produces too much acid, such as Zollinger-Ellison syndrome. Ranitidine also treats gastroesophageal reflux disease (GERD) and other conditions in which acid backs up from the stomach into the esophagus, causing heartburn and injury of the food pipe (esophagus).

Ranitidine is also used sometimes to treat upper gastrointestinal bleeding and to prevent stress ulcers, stomach damage from use of nonsteroidal anti-inflammatory drugs (NSAIDs), and aspiration of stomach acid during anesthesia. Talk to your doctor about the risks of using this medication for your condition.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Ranitidine reduces the amount of acid your stomach makes.

• Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Trials available to date have not assessed the safety of ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks.
• Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. No placebo-controlled comparative trials have been carried out for periods of longer than 1 year.
• The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis).
• Short-term treatment of active, benign gastric ulcer. Most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated. Trials available to date have not assessed the safety of ranitidine in uncomplicated, benign gastric ulcer for periods of more than 6 weeks.
• Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled trials have been carried out for 1 year.
• Treatment of gastro-esophageal reflux disease (GERD). Symptomatic relief commonly occurs within 24 hours after starting therapy with Zantac 150 mg twice daily.
• Treatment of endoscopically diagnosed erosive esophagitis. Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with ranitidine 150 mg 4 times daily.
• Maintenance of healing of erosive esophagitis. Placebo-controlled trials have been carried out for 48 weeks.

Concomitant antacids should be given as needed for pain relief to patients with active duodenal ulcer; active, benign gastric ulcer; hypersecretory states; GERD; and erosive esophagitis.

Ranitidine is also taken to prevent and treat stomach ulcers.

Sometimes, ranitidine is taken for a rare illness caused by a tumor in the pancreas or gut called Zollinger-Ellison syndrome.

Ranitidine dose

Usual Adult Dose for Duodenal Ulcer

Oral

• Treatment dose: 150 mg orally 2 times a day OR 300 mg orally once a day after the evening meal or at bedtime
• Maintenance dose: 150 mg orally once a day at bedtime
• Duration of therapy: 8 weeks (treatment); up to 1 year (maintenance)

Parenteral:

IM or IV (bolus or intermittent infusion) Injection:

-Usual dose: 50 mg IM or IV every 6 to 8 hours
-Maximum dose: 400 mg/day

Continuous IV Infusion:

-Usual rate: 6.25 mg/hour

Comments:

• Patients may use antacids to treat pain.
• Both once or 2 times a day oral dosing regimens were shown to be effective in inhibiting gastric acid secretion.
• Injectable formulations do not require dilution when given as an IM injection.
• Intermittent IV bolus injections should be diluted up to 2.5 mg/mL and injected at a rate of up to 4 mL/min.
• Intermittent IV infusions should be diluted up to a concentration of 0.5 mg/mL and infused at a rate of up to 5 to 7 mL/min (approximately 15 to 20 minutes).
• Most patients receiving oral formulations heal within 4 weeks; there are no safety data for the treatment of uncomplicated duodenal ulcer beyond 8 weeks. Studies have not been conducted to assess safety in oral maintenance therapy longer than 1 year.
  

Uses:

• Short-term treatment of active duodenal ulcer
• Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers
• Some hospitalized patients with intractable duodenal ulcers

Usual Adult Dose for Dyspepsia

ORAL (OVER-THE-COUNTER FORMULATIONS):

• Symptom relief: 75 to 150 mg orally with a glass of water
• Symptom prevention: 75 to 150 mg orally with a glass of water 30 to 60 minutes before a meal
• Maximum dose: 2 tablets/day
• Duration of therapy: Up to 14 days (self-treatment)

Uses:

• Relief of heartburn associated with acid indigestion and sour stomach
• Relief of heartburn associated with acid indigestion and sour stomach brought on by eating/drinking certain foods and beverages

Usual Adult Dose for Erosive Esophagitis

ORAL:

• Treatment dose: 150 mg orally 4 times a day
• Maintenance dose: 150 mg orally 2 times a day
• Duration of therapy: Up to 48 weeks (maintenance)

Comments:

• Symptomatic relief usually starts within 24 hours of starting oral treatment.
• Placebo-controlled studies included use of maintenance doses for up to 48 weeks.

Use:

• Treatment of endoscopically diagnosed erosive esophagitis

Usual Adult Dose for Zollinger-Ellison Syndrome

ORAL:

• Initial dose: 150 mg orally 2 times a day
• Maximum dose: Up to 6 g/day

PARENTERAL:
Continuous IV Infusion:

-Initial rate: 1 mg/kg/hr
-Titration: After 4 hours, if gastric acid output is greater than 10 mEq/hr or the patient is symptomatic, the dose should be increased in 0.5 mg/kg/hr increments and acid levels should be re-measured
-Maximum dose: 2.5 mg/kg/hr
-Maximum rate: 220 mg/hr

Comment:
-Continuous IV infusions should be diluted to a concentration of 2.5 mg/mL or less.

Uses:

• Treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, systemic mastocytosis)
• Alternative to oral formulations for short-term use in some hospitalized patients who are unable to take oral medications

Usual Adult Dose for Pathological Hypersecretory Conditions

ORAL:

• Initial dose: 150 mg orally 2 times a day
• Maximum dose: Up to 6 g/day

PARENTERAL:
Continuous IV Infusion:

-Initial rate: 1 mg/kg/hr
-Titration: After 4 hours, if gastric acid output is greater than 10 mEq/hr or the patient is symptomatic, the dose should be increased in 0.5 mg/kg/hr increments and acid levels should be re-measured
-Maximum dose: 2.5 mg/kg/hr
-Maximum rate: 220 mg/hr

Comment:
-Continuous IV infusions should be diluted to a concentration of 2.5 mg/mL or less.

Uses:

• Treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, systemic mastocytosis)
• Alternative to oral formulations for short-term use in some hospitalized patients who are unable to take oral medications

Usual Adult Dose for Gastroesophageal Reflux Disease (GERD)

ORAL:

• Usual dose: 150 mg orally 2 times a day

Comment:

Symptomatic relief usually starts within 24 hours of starting oral treatment.

Use:

Treatment of gastroesophageal reflux disease

Usual Adult Dose for Gastric Ulcer

ORAL:

• Treatment dose: 150 mg orally 2 times a day
• Maintenance dose: 150 mg orally once a day at bedtime

Comments:

Most patients heal within 6 weeks; there are no safety data for the treatment of uncomplicated, benign gastric ulcer beyond 6 weeks.

Uses:

Short-term treatment of active, benign gastric ulcer
Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers

Usual Pediatric Dose for Duodenal Ulcer

Less than 1 month AND with Extracorporeal membrane oxygenation:

PARENTERAL:
-2 mg/kg IV every 12 to 24 hours OR as a continuous infusion

1 month to 16 years:

ORAL:

• Treatment dose: 2 to 4 mg/kg orally 2 times a day
• Maximum treatment dose: 300 mg/day
• Maintenance dose: 2 to 4 mg/kg orally once a day
• Maximum maintenance dose: 150 mg/day

PARENTERAL:
-Usual dose: 2 to 4 mg/kg IV, divided and given every 6 to 8 hours OR as a continuous infusion
-Maximum dose: 50 mg/dose

16 years and older:

ORAL:

• Treatment dose: 150 mg orally 2 times a day OR 300 mg orally once a day after the evening meal or at bedtime
• Maintenance dose: 150 mg orally once a day at bedtime
• Duration of therapy: 8 weeks (treatment); up to 1 year (maintenance)

PARENTERAL:

IM or IV (bolus or intermittent infusion) Injection:
-Usual dose: 50 mg IM or IV every 6 to 8 hours
-Maximum dose: 400 mg/day

Continuous IV Infusion:
-Usual rate: 6.25 mg/hour

Comments:
-Patients younger than 1 month with ECMO who were given doses of 2 mg/kg had a gastric pH of greater than 4 for at least 15 hours.
-Placebo-controlled studies included use of maintenance doses for up to 48 weeks.
-Injectable formulations do not require dilution when given as an IM injection.
-Intermittent IV bolus injections should be diluted up to 2.5 mg/mL and injected at a rate of up to 4 mL/min.
-Intermittent IV infusions should be diluted up to a concentration of 0.5 mg/mL and infused at a rate of up to 5 to 7 mL/min (approximately 15 to 20 minutes).

Uses:

• Alternative to oral formulations for short-term use in some hospitalized patients who are unable to take oral medications
• Short-term treatment of active duodenal ulcer
• Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers
• Some hospitalized patients with intractable duodenal ulcers

Usual Pediatric Dose for Gastric Ulcer

Less than 1 month AND with Extracorporeal membrane oxygenation (ECMO):

PARENTERAL:

-2 mg/kg IV every 12 to 24 hours OR as a continuous infusion

1 month to 16 years:

ORAL:

• Treatment dose: 2 to 4 mg/kg orally 2 times a day
• Maximum treatment dose: 300 mg/day
• Maintenance dose: 2 to 4 mg/kg orally once a day
• Maximum maintenance dose: 150 mg/day

PARENTERAL:

-Usual dose: 2 to 4 mg/kg IV, divided and given every 6 to 8 hours OR as a continuous infusion
-Maximum dose: 50 mg/dose

16 years and older:

ORAL:

• Treatment dose: 150 mg orally 2 times a day OR 300 mg orally once a day after the evening meal or at bedtime
• Maintenance dose: 150 mg orally once a day at bedtime
• Duration of therapy: 8 weeks (treatment); up to 1 year (maintenance)

PARENTERAL:

IM or IV (bolus or intermittent infusion) Injection:

-Usual dose: 50 mg IM or IV every 6 to 8 hours
-Maximum dose: 400 mg/day

Continuous IV Infusion:

-Usual rate: 6.25 mg/hour

Comments:

• Patients younger than 1 month with extracorporeal membrane oxygenation who were given doses of 2 mg/kg had a gastric pH of greater than 4 for at least 15 hours.
• Placebo-controlled studies included use of maintenance doses for up to 48 weeks.
• Injectable formulations do not require dilution when given as an IM injection.
• Intermittent IV bolus injections should be diluted up to 2.5 mg/mL and injected at a rate of up to 4 mL/min.
• Intermittent IV infusions should be diluted up to a concentration of 0.5 mg/mL and infused at a rate of up to 5 to 7 mL/min (approximately 15 to 20 minutes).

Uses:

• Alternative to oral formulations for short-term use in some hospitalized patients who are unable to take oral medications
• Short-term treatment of active duodenal ulcer
• Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers
• Some hospitalized patients with intractable duodenal ulcers

Usual Pediatric Dose for Gastroesophageal Reflux Disease

1 month to 16 years:

ORAL:

Usual dose: 5 to 10 mg/kg/day orally, given in 2 divided doses

16 years and older:

ORAL:

Usual dose: 150 mg orally 2 times a day

Comments:

Symptomatic relief usually starts within 24 hours of starting oral treatment.
Placebo-controlled studies included use of maintenance doses for up to 48 weeks.

Use:

Treatment of gastroesophageal reflux disease

Usual Pediatric Dose for Erosive Esophagitis

1 month to 16 years:

ORAL:

Usual dose: 5 to 10 mg/kg/day, given in 2 divided doses

16 years and older:

ORAL:

• Treatment dose: 150 mg orally 4 times a day
• Maintenance dose: 150 mg orally 2 times a day
• Duration of therapy: Up to 48 weeks (maintenance)

Comments:

• Symptomatic relief usually starts within 24 hours of starting oral treatment.
• Placebo-controlled studies included use of maintenance doses for up to 48 weeks.

Use:

Treatment of endoscopically diagnosed erosive esophagitis

Usual Pediatric Dose for Dyspepsia

12 years and older:

ORAL (OVER-THE-COUNTER FORMULATIONS):

• Symptom relief: 75 mg orally with a glass of water
• Symptom prevention: 75 mg orally with a glass of water 30 to 60 minutes before a meal
• Maximum dose: 150 mg/day
• Duration of therapy: Up to 14 days (self-treatment)

Uses:

• Relieve heartburn associated with acid indigestion and sour stomach
• Relieve heartburn associated with acid indigestion and sour stomach brought on by eating/drinking certain foods and beverages

Renal Dose Adjustments

Creatinine Clearance less than 50 mL/min:

Oral: 150 mg orally every 24 hours. The frequency of dosing may be increased with caution.

Parenteral:

• IM/IV: 50 mg IM/IV every 18 to 24 hours. The frequency of dosing may be increased to every 12 hours (or further) with caution.
• Continuous infusion: Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

Elderly patients: Since elderly patients are more likely to have decreased renal function, dose selection should be made cautiously, and an increased frequency of renal function monitoring should be considered.

How and when to take ranitidine

It’s usual to take ranitidine twice a day – 1 dose in the morning and 1 dose in the evening. Some people only need to take ranitidine once a day, at bedtime.

Very young babies, and people with Zollinger-Ellison syndrome, usually take ranitidine 3 times a day. People with severe inflammation of the food pipe (esophagitis) may need to take it 4 times a day.

How to take ranitidine

Take ranitidine exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Your doctor may recommend an antacid to help relieve pain. Carefully follow your doctor’s directions about the type of antacid to use, and when to use it.

You can take ranitidine with or without food. However, if you get symptoms whenever you eat or drink, take your medicine 30 minutes to 60 minutes before having a drink, snack or meal.

• Tablets – swallow tablets whole with a glass of water, milk or juice.
• Soluble tablets – dissolve tablets in half a glass of water. Do not use milk, fizzy water or other fizzy drinks. Wait until the medicine has completely dissolved and then drink it straight away.
• Liquid – this comes with a syringe or spoon to help you measure it. If you don’t have a syringe or spoon, ask your pharmacist for one. Do not use a kitchen teaspoon as it won’t give you the right amount.

Liquid ranitidine is suitable for children and people who find it difficult to swallow tablets.

Do not crush, chew, or break the ranitidine effervescent tablet, and do not allow it to dissolve on your tongue. The 25-milligram effervescent tablet must be dissolved in at least 1 teaspoon of water before swallowing. The150-milligram effervescent tablet should be dissolved in 6 to 8 ounces of water.

Allow the ranitidine effervescent tablet to dissolve completely in the water, and then drink the entire mixture. If you are giving this medicine to a child, you may draw the liquid mixture into a medicine dropper and empty the dropper into the child’s mouth.

Ranitidine granules should be mixed with 6 to 8 ounces of water before drinking.

Measure ranitidine liquid with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

It may take up to 8 weeks before your ulcer heals. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 6 weeks of treatment.

This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using ranitidine.

Store ranitidine at room temperature away from moisture, heat, and light.

Active Duodenal Ulcer:

The current recommended adult oral dosage of ranitidine for duodenal ulcer is 150 mg twice daily. An alternative dosage of 300 mg once daily after the evening meal or at bedtime can be used for patients in whom dosing convenience is important. The advantages of one treatment regimen compared with the other in a particular patient population have yet to be demonstrated. Smaller doses have been shown to be equally effective in inhibiting gastric acid secretion in US trials, and several foreign trials have shown that 100 mg twice daily is as effective as the 150-mg dose.

Antacid should be given as needed for relief of pain.

Maintenance of Healing of Duodenal Ulcers:

The current recommended adult oral dosage is 150 mg at bedtime.

Pathological Hypersecretory Conditions (such as Zollinger-Ellison syndrome):

The current recommended adult oral dosage is 150 mg twice daily. In some patients it may be necessary to administer ranitidine 150-mg doses more frequently. Dosages should be adjusted to individual patient needs, and should continue as long as clinically indicated. Dosages up to 6 g/day have been employed in patients with severe disease.

Benign Gastric Ulcer:

The current recommended adult oral dosage is 150 mg twice daily.

Maintenance of Healing of Gastric Ulcers:

The current recommended adult oral dosage is 150 mg at bedtime.

Gastro-esophageal reflux disease (GERD):

The current recommended adult oral dosage is 150 mg twice daily.

Erosive Esophagitis:

The current recommended adult oral dosage is 150 mg 4 times daily.

Maintenance of Healing of Erosive Esophagitis:

The current recommended adult oral dosage is 150 mg twice daily.

Pediatric Use:

The safety and effectiveness of ranitidine have been established in the age-group of 1 month to 16 years. There is insufficient information about the pharmacokinetics of ranitidine in neonatal patients (aged younger than 1 month) to make dosing recommendations.

The following 3 subsections provide dosing information for each of the pediatric indications.

• Treatment of Duodenal and Gastric Ulcers: The recommended oral dose for the treatment of active duodenal and gastric ulcers is 2 to 4 mg/kg twice daily to a maximum of 300 mg/day. This recommendation is derived from adult clinical trials and pharmacokinetic data in pediatric patients.
• Maintenance of Healing of Duodenal and Gastric Ulcers: The recommended oral dose for the maintenance of healing of duodenal and gastric ulcers is 2 to 4 mg/kg once daily to a maximum of 150 mg/day. This recommendation is derived from adult clinical trials and pharmacokinetic data in pediatric patients.
• Treatment of GERD and Erosive Esophagitis: Although limited data exist for these conditions in pediatric patients, published literature supports a dosage of 5 to 10 mg/kg/day, usually given as 2 divided doses.

Dosage Adjustment for Patients with Impaired Renal Function:

On the basis of experience with a group of subjects with severely impaired renal function treated with ranitidine, the recommended dosage in patients with a creatinine clearance <50 mL/min is 150 mg every 24 hours. Should the patient’s condition require, the frequency of dosing may be increased to every 12 hours or even further with caution. Hemodialysis reduces the level of circulating ranitidine. Ideally, the dosing schedule should be adjusted so that the timing of a scheduled dose coincides with the end of hemodialysis.

Elderly patients are more likely to have decreased renal function, therefore caution should be exercised in dose selection, and it may be useful to monitor renal function.

Will my dose go up or down?

Sometimes your doctor will increase your dose of ranitidine if it isn’t working well enough.

Depending on the reason you take ranitidine, you may take a higher dose to start with – usually for at least 1 month. After this, your doctor may recommend a lower dose.

What if I forget to take ranitidine?

If you usually take it:

• once a day, take the missed dose as soon as you remember, unless it’s less than 12 hours until your next dose – in which case skip the missed dose
• twice a day, take the missed dose as soon as you remember, unless it’s nearly time for your next dose – in which case skip the missed dose
• 3 or 4 times a day, skip the missed dose and take your next dose as normal

Do NOT take a double dose to make up for a forgotten dose.

If you often forget doses, it may help to set an alarm to remind you. You could also ask your pharmacist for advice on other ways to remember your medicine.

What if I take too much ranitidine?

Ranitidine is generally very safe. Taking too much is unlikely to harm you or your child.

If you take an extra dose by mistake, you might get some side effects, such as feeling sick. Call your doctor if you’re worried, or you’re bothered by side effects.

Ranitidine side effects

Most people who take ranitidine do not have any side effects. If you do get a side effect, it is usually mild and will go away when you stop taking ranitidine.

The following side effects aren’t common and may happen in more than 1 in 1,000 people. Talk to your doctor or pharmacist if these side effects bother you or don’t go away:

• stomach pains
• constipation
• feeling sick (nausea)
• headache
• diarrhea
• vomiting

Ranitidine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

These are not all the side effects of ranitidine. For a full list see the leaflet inside your medicines packet.

The following have been reported as events in clinical trials or in the routine management of patients treated with ranitidine. The relationship to therapy with ranitidine has been unclear in many cases. Headache, sometimes severe, seems to be related to administration of ranitidine.

Central Nervous System

Rarely, malaise, dizziness, somnolence, insomnia, and vertigo. Rare cases of reversible mental confusion, agitation, depression, and hallucinations have been reported, predominantly in severely ill elderly patients. Rare cases of reversible blurred vision suggestive of a change in accommodation have been reported. Rare reports of reversible involuntary motor disturbances have been received.

Cardiovascular

As with other H2-blockers, rare reports of arrhythmias such as tachycardia, bradycardia, atrioventricular block, and premature ventricular beats.

Gastrointestinal

Constipation, diarrhea, nausea/vomiting, abdominal discomfort/pain, and rare reports of pancreatitis.

Hepatic

There have been occasional reports of hepatocellular, cholestatic, or mixed hepatitis, with or without jaundice. In such circumstances, ranitidine should be immediately discontinued. These events are usually reversible, but in rare circumstances death has occurred. Rare cases of hepatic failure have also been reported. In normal volunteers, SGPT values were increased to at least twice the pretreatment levels in 6 of 12 subjects receiving 100 mg intravenously 4 times daily for 7 days, and in 4 of 24 subjects receiving 50 mg intravenously 4 times daily for 5 days.

Musculoskeletal

Rare reports of arthralgias and myalgias.

Hematologic

Blood count changes (leukopenia, granulocytopenia, and thrombocytopenia) have occurred in a few patients. These were usually reversible. Rare cases of agranulocytosis, pancytopenia, sometimes with marrow hypoplasia, and aplastic anemia and exceedingly rare cases of acquired immune hemolytic anemia have been reported.

Endocrine

Controlled studies in animals and man have shown no stimulation of any pituitary hormone by ranitidine and no antiandrogenic activity, and cimetidine-induced gynecomastia and impotence in hypersecretory patients have resolved when ranitidine has been substituted. However, occasional cases of impotence and loss of libido have been reported in male patients receiving ranitidine, but the incidence did not differ from that in the general population. Rare cases of breast symptoms and conditions, including galactorrhea and gynecomastia, have been reported in both males and females.

Integumentary

Rash, including rare cases of erythema multiforme. Rare cases of alopecia and vasculitis.

Respiratory

A large epidemiological study suggested an increased risk of developing pneumonia in current users of histamine-2-receptor antagonists (H2RAs) compared with patients who had stopped H2RA treatment, with an observed adjusted relative risk of 1.63. However, a causal relationship between use of H2RAs and pneumonia has not been established.

Other

Rare cases of hypersensitivity reactions (e.g., bronchospasm, fever, rash, eosinophilia), anaphylaxis, angioneurotic edema, acute interstitial nephritis, and small increases in serum creatinine.

Serious side effects

Serious side effects are very rare and happen in less than 1 in 10,000 people. Call a doctor straight away if you have:

• stomach pain that seems to be getting worse – this can be a sign of an inflamed liver or pancreas
• back pain, fever, pain when peeing or blood in your pee – these can be signs of kidney problems
• a rash, swollen joints or kidney problems – these can be signs that your small blood vessels are swollen (vasculitis)
• a slow or irregular heartbeat

Serious allergic reaction

In rare cases, it’s possible to have a serious allergic reaction to ranitidine.

• A serious allergic reaction is an emergency. Contact a doctor straight away if you think you or someone around you is having a serious allergic reaction.

The warning signs of a serious allergic reaction are:

• getting a skin rash that may include itchy, red, swollen, blistered or peeling skin
• wheezing
• tightness in the chest or throat
• having trouble breathing or talking
• swelling of the mouth, face, lips, tongue or throat

How to cope with side effects

What to do about:

• stomach pains – try to rest and relax. It can help to eat and drink slowly and have smaller and more frequent meals. Putting a heat pad or covered hot water bottle on your tummy may also help. If you are in a lot of pain, speak to your pharmacist or doctor.
• constipation – eat more high-fiber foods such as fresh fruit and vegetables and cereals, and drink plenty of water. Try to exercise more regularly, for example, by going for a daily walk or run. If this doesn’t help, talk to your pharmacist or doctor.
• feeling sick – it may help if you don’t eat rich or spicy food while you’re taking ranitidine.

Human Toxicity Reports

Headache (sometimes severe) occurs in approx 3% of patients receiving the drug ². Malaise, dizziness, somnolence, insomnia, and vertigo have been reported less frequently. Reversible mental confusion, agitation, mental depression, and hallucinations have occurred, mainly in debilitated geriatric patients. A child who was receiving prolonged, high-dose oral ranitidine therapy (8 mg/kg once daily for 10 months) developed altered consciousness, drowsiness, dysarthria, hyporeflexia, positive Babinski’s sign, diaphoresis, and bradycardia, which resolved within 24 hr after discontinuance of the drug.

Constipation, nausea, vomiting, and abdominal discomfort or pain have occurred in patients receiving ranitidine. Pancreatitis has been reported rarely ².

Rash, which may be urticarial, maculopapular, and/or pruritic, has been reported during ranitidine therapy ². Rash suggestive of mild erythema multiforme has occurred rarely. Urticaria at the site of injection has occurred following IV admin of ranitidine. Alopecia has occurred rarely ².

Leukopenia, granulocytopenia, agranulocytosis, thrombocytopenia, aplastic anemia, acquired immune hemolytic anemia, and pancytopenia, which may be accompanied by bone marrow hypoplasia, have been reported rarely in patients receiving ranitidine ². Alterations in blood cell counts usually were reversible. At least one case of leukocytosis has been reported 6-8 days after initiating ranitidine therapy, which resolved following discontinuance ². Aplastic anemia has occurred in at least one patient receiving ranitidine ².

Small increases in serum creatinine, without concomitant increases in BUN, have been reported during ranitidine therapy ². Increases in serum aminotransferase, alkaline phosphatase, LDH, total bilirubin, and gamma-glutamyl transferase concentration have been reported and reversible hepatitis, which may be hepatocellular, hepatocanalicular, or both and may or may not be accompanied by jaundice, has occurred occasionally in individuals receiving ranitidine and usually was reversible; however, death has been reported rarely ².

A 63 yr old woman developed anicteric hepatitis after two wk of therapy with ranitidine ³. Despite continuation of therapy, her symptoms resolved within 5 days and transaminase levels returned to normal in the next 4 weeks, at which time use of the drug ceased. No other cause for the reaction could be found ³.

Cardiac arrhythmias have occurred rarely in patients receiving ranitidine ². Bradycardia, sometimes assoc with dyspnea, has occurred ². Tachycardia, AV block, asystole, and ventricular premature complexes have also been reported rarely ².

Arthralgias, myalgias, and hypersensitivity reactions such as bronchospasm, fever, rash, and eosinophilia have occurred rarely in patients receiving ranitidine ². Anaphylaxis, characterized by severe urticaria and a decrease in blood pressure in one patient following administration of a single dose of ranitidine, has occurred rarely; exacerbation of asthma and angioedema also has occurred ². Mild erythema multiforme-like rash and alopecia also have occurred rarely. Rare reports suggest that ranitidine may precipitate acute attacks of porphyria in patients with acute porphyria; therefore, the drug should be avoided in patients with a history of acute porphyria ².

In a study of 51 male patients with duodenal ulcer, treatment with ranitidine, produced no decrease in basal levels of serum testosterone, as did cimetidine ⁴.

Ranitidine inhibited in a dose-dependent manner acetylcholinesterases from human erythrocytes and gastric mucosa ⁵. Pseudocholinesterase in serum was also inhibited, the levels required were about 25 times higher. A stimulation of cholinergic mechanisms in ranitidine treatment should occur, e.g, stimulation of glandular secretion or increase of gastrointestinal motility ⁵.

Symptoms of acute intoxication with both cimetidine and ranitidine are bradycardia and tachycardia ⁶; CNS disturbances, including confusion, delirium, drowsiness, slurred speech, flushing, and sweating; dermatologic lesions; endocrine abnormalities; GI disorders; and liver dysfunction ⁶.

Most controlled studies in humans indicate that ranitidine does not alter theophylline metabolism, even at high doses ⁷. However, there have been several case reports published recently which demonstrate the development of theophylline toxicity mostly in older patients receiving stable oral doses of this drug when ranitidine was administered simultaneously ⁷. A study involving eleven elderly (mean age, 69.0 + or – 6.2 years) patients with chronic obstructive pulmonary disease (COPD). During one week the patients took slow-release theophylline, 200 mg every 12 hr, followed by one week intake of the same dose of theophylline plus ranitidine tablets, 150 mg every 12 hr. At the end of each period, blood samples were obtained 0, 1, 2, 3, 4, 5, 6, 7, 8 and 12 hr after the morning dose for the determination of serum theophylline levels. The peak theophylline concentration (Tmax) was achieved after 4.1 + or – 0.9 hr while the patients were taking theophylline, and after 2.9 + or – 1.4 hr with the combined regimen. This difference was statistically significant. In only 3/11 subjects did Tmax remain unchanged during both phases of the study. The mean theophylline clearance rates while the patients were receiving theophylline alone (39.58 + or – 19.89 ml/min) and when they were receiving both medications 134.42 + or – 10.55 ml/min) were similar. The mean serum levels while the patients were receiving theophylline alone were slightly higher but not statistically different. These results suggest that the reported increases in serum theophylline levels in older patients receiving theophylline and ranitidine cannot be ascribed to slower theophylline metabolism in the geriatric patients with chronic obstructive pulmonary disease who is also given ranitidine ⁷.

A case report of acute cholestatic hepatitis associated with rash and hypereosinophilia, in which the absence of transfusion, intercurrent viral infection, alcohol consumption or other hepatotoxic drugs are suggestive of ranitidine-induced hepatotoxicity ⁸. The pathogenesis of the disorder is unknown, but the lack of a dose-effect relationship, the rarity and unpredictability of the reaction, as well as the clinical signs suggest that hypersensitivity is involved. Physicians should be aware of this rare and idiosyncratic side-effect of ranitidine ⁸.

Although acute interstitial nephritis has been well described with the histamine H2-receptor antagonist cimetidine, a study authors found only one previous case report of ranitidine-induced interstitial nephritis in the literature ⁹. They describe an additional patient who developed acute interstitial nephritis after taking ranitidine ⁹. Electron microscopy showed focal fusion of the epithelial cell foot processes that was not described in the previous report of ranitidine-induced interstitial nephritis.

Reversible hematologic abnormalities including hemolytic anemia ¹⁰ with a positive direct Coombs’ test have been associated with ranitidine. In addition to the case report cited above, the US Food and Drug Administration had received five other cases of hemolysis associated with recent intake of ranitidine as of February 1991 ¹⁰. To investigate the possible association of ranitidine with autoimmune hemolytic anemia, a study was conducted to determine how often diagnoses of hemolytic anemia or abnormal Coombs’ test results followed dispensing of ranitidine using the automated medical and pharmacy records of a large health maintenance organization. No occurrences of hemolytic anemia were identified among 12,054 individuals following 38,686 prescriptions for this medication. The 95% upper confidence bound was 3.1 cases/10,000 exposed persons. One abnormal direct Coombs test with mild anemia was discovered during routine prenatal testing of an asymptomatic patient who was dispensed ranitidine two and a half months previously. Hemolysis, however, was not demonstrated and an association with prior ranitidine use could not be confirmed. Additional analyses indicate that in only 30% of ranitidine courses was a blood count obtained. In those courses with hematocrits below 40%, less than 1% had a Coombs’ test performed. Chart review suggests that the majority of individuals with severe anemia have alternative explanations other than autoimmune hemolysis for their anemia ¹⁰. This analysis indicates that ranitidine is unlikely to be a common cause of clinically recognized autoimmune hemolytic anemia and demonstrates the utility of large automated medical and pharmacy data bases to conduct post-marketing studies of spontaneously reported drug effects.

Ranitidine overdose

Ranitidine overdose occurs when someone takes more than the normal or recommended amount of this medicine. This can be by accident or on purpose.

There has been limited experience with overdosage. Reported acute ingestions of up to 18 g orally have been associated with transient adverse effects similar to those encountered in normal clinical experience. In addition, abnormalities of gait and hypotension have been reported.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. This is a free and confidential service. All local poison control centers in the United States use this national number. You should call if you have any questions about poisoning or poison prevention. It does NOT need to be an emergency. You can call for any reason, 24 hours a day, 7 days a week.

Symptoms of an ranitidine overdose are:

• Abnormal heartbeat, including rapid or slow heartbeat
• Drowsiness, confusion
• Diarrhea
• Difficulty breathing
• Dilated pupils
• Flushing
• Low blood pressure
• Nausea, vomiting
• Slurred speech
• Sweating

Seek medical help right away. DO NOT make the person throw up unless poison control or a health care provider tells you to.

When overdosage occurs, the usual measures to remove unabsorbed material from the gastrointestinal tract, clinical monitoring, and supportive therapy should be employed.

Studies in dogs receiving dosages of ranitidine in excess of 225 mg/kg/day have shown muscular tremors, vomiting, and rapid respiration. Single oral doses of 1,000 mg/kg in mice and rats were not lethal. Intravenous LD50 values in mice and rats were 77 and 83 mg/kg, respectively.

What to Expect at the Emergency Room

Take the container with you to the hospital, if possible.

The provider will measure and monitor the person’s vital signs, including temperature, pulse, breathing rate, and blood pressure. Symptoms will be treated. The person may receive:

• Activated charcoal
• Blood and urine tests
• Breathing support, including oxygen
• Chest x-ray
• ECG (electrocardiogram, or heart tracing)
• Intravenous fluids (through a vein)
• A laxative
• Medicine to treat symptoms
• Tube through the mouth into the stomach to empty the stomach (gastric lavage)

Outlook (Prognosis)

Serious complications are rare. These are generally safe medicines, even when taken in large doses.

1. McEvoy G.K. (ed.). American Hospital Formulary Service-Drug Information 96. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 1996 (Plus Supplements)., p. 2184[↩]
2. McEvoy G.K. (ed.). American Hospital Formulary Service-Drug Information 96. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 1996 (Plus Supplements)., p. 2182[↩][↩][↩][↩][↩][↩][↩][↩][↩][↩][↩][↩][↩][↩][↩]
3. Barr GD, Piper DW; Med J Aust 2 (8): 421; 1981 https://www.ncbi.nlm.nih.gov/pubmed/6275248[↩][↩]
4. Peden NR et al; Acta Endocrinol (Copenh) 96 (4): 564-8;1981 http://www.eje-online.org/content/96/4/564.long[↩]
5. Hansen WE, Bertl S; Z Gastroenterol 21 (4): 164-7;1983 https://www.ncbi.nlm.nih.gov/pubmed/6306938[↩][↩]
6. Haddad, L.M., Clinical Management of Poisoning and Drug Overdose. 2nd ed. Philadelphia, PA: W.B. Saunders Co., 1990., p. 824[↩][↩]
7. Cukier A et al; Braz J Med Biol Res 28 (8): 875-9;1995 https://www.ncbi.nlm.nih.gov/pubmed/8555989[↩][↩][↩]
8. Devuyst C et al; Acta Clin Belg 48 (2): 109-14;1993 https://www.ncbi.nlm.nih.gov/pubmed/8392242[↩][↩]
9. Gaughan WJ et al; Am J Kidney Dis 22 (2): 337-40;1993 https://www.ncbi.nlm.nih.gov/pubmed/8352263[↩][↩]
10. Choo PW et al; J Clin Epidemiol 47 (lO): 1175-9; 1994 ttps://www.ncbi.nlm.nih.gov/pubmed/7722551[↩][↩][↩]

What is loratadine

Loratadine is a non-drowsy antihistamine (a second generation antihistamine) medicine that relieves the symptoms of allergies. Loratadine is used to treat hay fever, allergic conjunctivitis (red, itchy eye), eczema and hives. Loratadine is also used for reactions to insect bites and stings and for some food allergies. Loratadine is much less likely to make you feel sleepy than some other antihistamines such as diphenhydramine. Most people prefer to take a non-drowsy antihistamine instead of a sedating one. An exception is when you want the medicine to make you sleepy because you’ve got itchy skin that’s keeping you awake.

Loratadine is a histamine [H1] receptor blocker, it works by blocking the action of histamine, a substance in the body that causes allergic symptoms. When you come into contact with something you have an allergy to, such as pollen, animal hair or fur, house dust or insect bites, your body produces a chemical called histamine. Histamine is a chemical that’s released by Mast cells in your body when an allergen is encountered that can produce symptoms of sneezing, hives, itching, watery eyes, and runny nose, also known as hypersensitivity reactions. Usually histamine is a useful substance but in an allergic reaction it causes unpleasant symptoms including itchy, watery eyes, running or blocked nose, sneezing and skin rashes. Loratadine blocks the effects of histamine and so reduces these symptoms.

Loratadine is also available in combination with pseudoephedrine (Sudafed, others). This article only includes information about the use of loratadine alone. If you are taking the loratadine and pseudoephedrine combination product, read the information on the package label or ask your doctor or pharmacist for more information.

Loratadine is available on prescription. You can also buy loratadine from pharmacies and supermarkets.

Loratadine comes as a syrup (liquid), an immediate acting and extended release tablet, and a rapidly disintegrating (dissolving) tablet to take by mouth. It is usually taken once a day with or without food. Follow the directions on the package label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take loratadine exactly as directed. Do not take more or less of it or take it more often than directed on the package label or recommended by your doctor. If you take more loratadine than directed, you may experience drowsiness.

If you are taking the rapidly disintegrating tablet, follow the package directions to remove the tablet from the blister package without breaking the tablet. Do not try to push the tablet through the foil. After you remove the tablet from the blister package, immediately place it on your tongue and close your mouth. The tablet will quickly dissolve and can be swallowed with or without water.

Do not use loratadine to treat hives that are bruised or blistered, that are an unusual color, or that do not itch. Call your doctor if you have this type of hives.

Stop taking loratadine and call your doctor if your hives do not improve during the first 3 days of your treatment or if your hives last longer than 6 weeks. If you do not know the cause of your hives, call your doctor.

If you are taking loratadine to treat hives, and you develop any of the following symptoms, get emergency medical help right away:

• difficulty swallowing,
• speaking, or breathing;
• swelling in and around the mouth or swelling of the tongue;
• wheezing; drooling;
• dizziness; or loss of consciousness.

These may be symptoms of a life-threatening allergic reaction called anaphylaxis. If your doctor suspects that you may experience anaphylaxis with your hives, he may prescribe an epinephrine injector (EpiPen). Do not use loratadine in place of the epinephrine injector.

Do not use this medication if the safety seal is open or torn.

Loratadine was evaluated for efficacy and safety in 228 patients with perennial allergic rhinitis. Taken at a dose of 10 mg once daily, loratadine was significantly more effective than placebo and comparable to terfenadine, 60 mg taken twice daily, in reducing combined symptom scores in this patient population. Efficacy was maintained throughout the 28 day course of treatment ¹. The overall incidence of side effects with loratadine was low (14%) with few occurrences of sedation (3%) and dry mouth (4%).

Key facts

• It’s usual to take loratadine once a day.
• Loratadine is classed as a non-drowsy antihistamine, but some people still find it makes them feel slightly sleepy.
• Children may also have a headache and feel tired or nervous after taking loratadine.
• It’s best NOT to drink alcohol while you’re taking loratadine as it can make you feel sleepy.
• Loratadine is also called by the brand names Clarityn Allergy, Clarityn Rapide Allergy, Alavert, Claritin, Claritin Reditab, Clear-Atadine, Dimetapp ND, ohm Allergy Relief, QlearQuil All Day & Night, Tavist ND, Wal-itin.

Before taking loratadine – Precautions

• tell your doctor and pharmacist if you are allergic to loratadine, any other medications, or any of the ingredients in the type of loratadine you will be taking. Check the package label for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements and herbal products you are taking or plan to take. Be sure to mention medications for colds and allergies.
• tell your doctor if you have or have ever had asthma or kidney or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking loratadine, call your doctor.
• if you have phenylketonuria (PKU, an inherited condition in which a special diet must be followed to prevent mental retardation), you should know that some brands of the orally disintegrating tablets may contain aspartame that forms phenylalanine.

Loratadine and alcohol

It’s best not to drink alcohol while you’re taking loratadine, as it can make you feel sleepy, drowsy and dizzy and increased your risk for loratadine overdose.

When will I feel better?

You should start to feel better within an hour.

How long should I take loratadine for?

It depends on why you’re taking it.

You may only need to take loratadine for a short time or as a one-off dose. If you have a reaction to an insect bite, you may only need to take loratadine for a day or 2.

You may need to take it for longer if you’re taking it to prevent symptoms from hay fever when the pollen count is high.

Talk to your doctor or pharmacist if you’re unsure how long you need to take loratadine for.

Is it safe to take loratadine for a long time?

Loratadine is unlikely to do you any harm if you take it for a long time. However, it’s best to take loratadine only for as long as you need to.

Can I take more than one antihistamine together?

Sometimes doctors recommend that people with severe itchy skin rash take 2 different antihistamines together for a few days.

As well as taking a non-drowsy antihistamine like loratadine during the day, your doctor may tell you to take a sedating antihistamine (e.g. Benadryl) at night if the itch is making it difficult to sleep.

Do not take 2 antihistamines together unless recommended by your doctor.

Can I take loratadine at higher doses than on the packet?

Your doctor might suggest you or your child take a higher dose of loratadine (up to 4 times the usual dose) for severe itchy skin rash or angioedema (swelling underneath the skin).

Taking high doses of loratadine isn’t suitable for everyone though. Speak to your doctor if you think loratadine isn’t working for you.

Can I take loratadine with other hay fever treatments?

Yes, it’s fine to take loratadine together with other hay fever treatments, for example steroid nasal sprays (such as Beconase, Rhinacort Aqua and Flixonase Nasules) or eye drops.

Can I take loratadine with painkillers?

Yes, you can take loratadine together with acetaminophen (Tylenol) or ibuprofen (Motrin or Advil).

Is there any food or drinks I need to avoid?

You can eat and drink normally while taking loratadine.

Can I drive or ride a bike with it?

Loratadine is classed as a non-drowsy antihistamine but it’s still possible to feel sleepy after taking it.

If this happens to you, don’t drive a car or ride a bike until you feel better.

Can lifestyle changes relieve hay fever?

It will help if you don’t spend too much time outside if the pollen count is high. Also:

Tips for when you’re outside:

• Don’t cut grass or walk on grass.
• Wear wraparound sunglasses to stop pollen getting into your eyes.
• Put Vaseline around your nostrils to help trap pollen.
• Shower and change your clothes after you’ve been outside to wash off pollen.

Tips for when you’re inside:

• Keep windows and doors shut as much as possible.
• Vacuum regularly and dust with a damp cloth.
• Don’t keep fresh flowers in the house.
• Don’t smoke or be around smoke as it makes hay fever symptoms worse.

Who can and can’t take loratadine

Loratadine can be taken by adults and children aged 2 years and older.

Loratadine isn’t suitable for some people. Tell your doctor or pharmacist if you:

• have had an allergy to loratadine or any other medicines in the past
• have severe liver failure
• have an intolerance to, or cannot absorb, some sugars such as lactose or sucrose
• have epilepsy or another illness that puts you at risk of fits
• have a rare illness called porphyria
• are booked to have an allergy test – taking loratadine may affect the results so you might need to stop taking it a few days before the test

Cautions with other medicines

Some medicines and loratadine interfere with each other and increase the chances of you having side effects.

Tell your doctor if you’re taking:

• amiodarone, a medicine used to treat an irregular heart beat
• cimetidine, an indigestion medicine
• erythromycin, an antibiotic
• ketoconazole, a medicine to treat fungal infections
• midodrine, a medicine used to treat low blood pressure
• ritonavir, a medicine used to treat HIV infection
• any medicine that makes you feel sleepy, gives you a dry mouth or makes it difficult for you to pee. Taking loratadine might make these side effects worse.

Tell your doctor or pharmacist if you’re taking any other medicines, including herbal remedies, vitamins or supplements.

Mixing loratadine with herbal remedies and supplements

There might be a problem taking some herbal remedies and supplements alongside loratadine – especially ones that cause sleepiness, a dry mouth or make it difficult to pee.

Ask your pharmacist for advice.

Loratadine in pregnancy and breastfeeding

It’s generally safe to take loratadine during pregnancy and while breastfeeding.

Can taking loratadine during pregnancy cause birth defects?

It is unlikely that loratadine would cause an increased chance for birth defects. One study with several limitations suggested a small risk for hypospadias (a condition where the opening of the penis is on the underside of the penis instead of at the tip). After collecting more data, this study author published another paper that admitted the increased risk originally seen may have been due to study limitation. In addition, additional studies of pregnant women taking loratadine have not supported an increased risk of any type of birth defect, including hypospadias. Also, studies involving infants with hypospadias did not find that their mothers used loratadine more frequently during pregnancy.

Can taking loratadine cause other pregnancy problems?

Loratadine is not expected to cause other pregnancy problems. A study of 161 women taking loratadine during the first trimester did not show any differences in the rates of delivery age, or birthweight compared to women who did not take loratadine.

I just found out that I am pregnant. Should I stop taking loratadine?

You should always speak with your healthcare provider before making any changes in your medication. It is important to consider the benefits of treating allergy symptoms during pregnancy. Treating allergy symptoms may help reduce asthma symptoms and sinus problems. This can prevent the need for extra medications. Allergy treatment may also lead to better sleep and emotional well-being.

Does taking loratadine during my pregnancy increase the chance of miscarriage?

Probably not. A study of 161 women taking loratadine during the first trimester did not show any differences in the rates of miscarriage.

Can loratadine make it harder for me to get pregnant?

One animal study did not report fertility issues in females exposed to loratadine. There are no other studies available.

Will loratadine affect my fertility?

There’s no evidence that loratadine affects male or female fertility.

Will loratadine affect my contraception?

For women, loratadine will not affect contraceptive pills or the morning after pill.

Loratadine and breastfeeding

If you’re breastfeeding and your baby was premature or has other health problems, talk to your doctor before taking loratadine.

Studies estimate that a breastfeeding baby whose mother is taking loratadine would get less than 1% of the mother’s dose. This dose of loratadine is thought to be too low to cause problems for the baby. Compared to some other antihistamines, loratadine has less chance of causing drowsiness for the mother or the baby. This, along with the low levels in milk, makes loratadine one of the preferred antihistamines for use during breastfeeding. Be sure to talk to your healthcare provider about all of your breastfeeding questions.

Because of its lack of sedation and low milk levels, maternal use of loratadine would not be expected to cause any adverse effects in breastfed infants ². Loratadine might have a negative effect on lactation, especially in combination with a sympathomimetic agent such as pseudoephedrine. The British Society for Allergy and Clinical Immunology recommends loratadine at its lowest dose as a preferred choice if an antihistamine is required during breastfeeding ².

After a single oral dose of 40 mg of loratadine in 6 women, average peak milk levels of 29.2 (range 20.4 to 39) mcg/L occurred at two hours after the dose ³. In addition, average desloratadine peak milk levels of 16 (range 9 to 29.6) mcg/L occurred at 5.3 hours after the dose. The total amount excreted in milk over 48 hours was 11.7 mcg of loratadine and its metabolite. However, the dose administered was four times greater than the usual dose of the drug, so a total dose of about 3 mcg would be expected with a 10 mg dose. The calculated average and maximum expected doses of loratadine plus desloratadine in milk were 0.46 and 1.1% and of the maternal weight-adjusted dose, respectively, after the 40 mg dose ³.

A survey of 51 mothers who took loratadine during breastfeeding between 1999 and 2001 was conducted by a teratogen information service ⁴. Most of the infants were over 2 months old and loratadine was generally taken for one week or less. Two mothers reported minor sedation in their infants, one at 3 days of age and one at 3 months of age. Both mothers were taking a dose of 10 mg daily. Weight gain and psychomotor development were similar to infants in a control group of breastfed infants unexposed to medications ⁵. An extension of the study that compared the results of this study (plus one additional patient) to that of a control group of 88 mothers who took a drug known to be safe while breastfeeding. No differences in sedation or any other side effects in the infant were found between mothers who took loratadine during breastfeeding and those of the control group ⁴.

Effects on Lactation and Breastmilk

Antihistamines in relatively high doses given by injection can decrease basal serum prolactin in nonlactating women and in early postpartum women ⁶, ⁷. However, suckling-induced prolactin secretion is not affected by antihistamine pretreatment of postpartum mothers ⁶. Whether lower oral doses of antihistamines have the same effect on serum prolactin or whether the effects on prolactin have any consequences on breastfeeding success have not been studied. The prolactin level in a mother with established lactation may not affect her ability to breastfeed.

One mother out of 51 mothers who took loratadine while nursing reported that she had decreased milk production after taking loratadine 10 mg daily for less than one week at 4 months postpartum ⁵.

What is loratadine used for?

Loratadine is often used to temporarily relieve the symptoms of hay fever (allergy to pollen, dust, or other substances in the air) and other allergies. These symptoms include sneezing, runny nose, and itchy eyes, nose, or throat. Loratadine is also used to treat itching and redness caused by hives. However, loratadine does not prevent hives or other allergic skin reactions.

Loratadine dosage

Applies to the following strengths loratadine: 10 mg; 5 mg/5 mL; 5 mg

Usual Adult Dose for Allergic Rhinitis

10 mg orally once a day

Maximum dose: 10 mg/day

Use: Temporary relief of symptoms associated with hay fever or other upper respiratory allergies (e.g., runny nose, itchy, watery eyes, sneezing, itching of the nose/throat)

Usual Adult Dose for Urticaria

10 mg orally once a day

Maximum dose: 10 mg/day

Use: Temporary relief of symptoms associated with hay fever or other upper respiratory allergies (e.g., runny nose, itchy, watery eyes, sneezing, itching of the nose/throat)

Usual Pediatric Dose for Allergic Rhinitis

• 2 to 5 years: 5 mg orally once a day

Maximum dose: 5 mg/day

• 6 years and older: 10 mg orally once a day

Maximum dose: 10 mg/day

Use: Temporary relief of symptoms associated with hay fever or other upper respiratory allergies (e.g., runny nose, itchy, watery eyes, sneezing, itching of the nose/throat)

Usual Pediatric Dose for Urticaria

• 2 to 5 years: 5 mg orally once a day

Maximum dose: 5 mg/day

• 6 years and older: 10 mg orally once a day

Maximum dose: 10 mg/day

Use: Temporary relief of symptoms associated with hay fever or other upper respiratory allergies (e.g., runny nose, itchy, watery eyes, sneezing, itching of the nose/throat)

Renal Dose Adjustments

Dose adjustment(s) may be required; however, no specific guidelines have been suggested. Caution recommended.

Liver Dose Adjustments

Dose adjustment(s) may be required; however, no specific guidelines have been suggested. Caution recommended.

How and when to take loratadine

If you or your child have been prescribed loratadine, follow your doctor’s instructions about how and when to take it. If you’ve bought loratadine from a pharmacy or shop, follow the instructions that come with the packet.

How much should I take?

Loratadine comes as 10mg tablets and as a liquid medicine (labelled either 5mg/ml or 1mg/1ml). You can take loratadine with or without food.

The usual dose in adults is 10mg once a day.

Doses are usually lower for people with liver problems.

For children, your doctor will use your child’s weight or age to work out the right dose.

In studies with loratadine tablets at doses 2 to 4 times higher than the recommended dose of 10 mg, a dose-related increase in the incidence of somnolence was observed. therefore, some patients, particularly those with hepatic or renal impairment and the elderly, may experience somnolence ⁸.

How to take loratadine

Loratadine comes as 2 different types of tablet – ordinary and melt-in-the-mouth tablets.

Swallow ordinary loratadine tablets with a drink of water, milk or juice. If the tablet has a score line, you can break it in half if you find it hard to swallow it whole. Do not chew it.

Melt-in-the-mouth tablets dissolve instantly on your tongue without needing a drink. Be careful not to crush them when you take them out of the packet.

Loratadine liquid may be easier for children to take than tablets. The medicine will come with a plastic syringe or spoon to help you measure out the right dose. If you don’t have a syringe or spoon, ask your pharmacist for one. Do not use a kitchen teaspoon as it will not give the right amount.

Loratadine tablets and melt-in-the-mouth tablets must only be taken by children aged between 2 and 12 years if they weigh 30kg or more. Give children loratadine liquid if they weigh less than 30kg.

When to take loratadine

You may only need to take loratadine on a day you have symptoms, such as if you’ve been exposed to a trigger like animal hair. Or you may need to take it regularly to prevent symptoms, such as hay fever during spring and summer.

What should I do if I forget a dose?

Take your forgotten dose as soon as you remember, unless it is nearly time for your next dose. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a forgotten dose.

If you forget doses often, it may help to set an alarm to remind you. You could also ask your pharmacist for advice on other ways to help you remember to take your medicine.

What if I take too much loratadine?

Loratadine is generally very safe. Taking too much is unlikely to harm you or your child.

If you take an extra dose by mistake, you might get a headache, have a rapid heartbeat or feel sleepy. If this happens or you’re concerned, contact your doctor.

Loratadine side effects

Like all medicines, loratadine can cause side effects although not everyone gets them.

Reported adverse events with an incidence of more than 2% in loratadine, 10 mg/daily versus placebo-controlled allergic rhinitis clinical trials percent of patients reporting: Headache (12%), Somnolence (8%), Fatigue (4%), Dry Mouth (3%) ⁹.

Common side effects

The most common side effect of loratadine is feeling sleepy. This happens in more than 1 in 100 people.

Children may also have a headache, feel tired or feel nervous. Talk to your doctor or pharmacist if these side effects bother you or don’t go away.

Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• dry mouth
• nosebleed
• sore throat
• mouth sores
• difficulty falling asleep or staying asleep
• nervousness
• weakness
• stomach pain
• diarrhea
• red or itchy eyes

The following adverse events have been reported in 2% or fewer patients ⁹:

Autonomic Nervous System

Altered lacrimation, altered salivation, flushing, hypesthesia, impotence, increased sweating, thirst.

Body As a Whole

Angioneurotic edema, asthenia, back pain, blurred vision, chest pain, conjunctivitis, earache, eye pain, fever, leg cramps, malaise, rigors, tinnitus, upper respiratory infection, weight gain.

Cardiovascular System

Hypertension, hypotension, palpitations, syncope, tachycardia.

Central and Peripheral Nervous System

Blepharospasm, dizziness, dysphonia, hyperkinesia, migraine, paresthesia, tremor, vertigo.

Gastrointestinal System

Abdominal distress, altered taste, anorexia, constipation, diarrhea, dyspepsia, flatulence, gastritis, increased appetite, nausea, stomatitis, toothache, vomiting.

Musculoskeletal System

Arthralgia, myalgia. Psychiatric: Agitation, amnesia, anxiety, confusion, decreased libido, depression, impaired concentration, insomnia, nervousness, paroniria.

Reproductive System

Breast pain, dysmenorrhea, menorrhagia, vaginitis.

Respiratory System

Bronchitis, bronchospasm, coughing, dyspnea, epistaxis, hemoptysis, laryngitis, nasal congestion, nasal dryness, pharyngitis, sinusitis, sneezing.

Skin and Appendages

Dermatitis, dry hair, dry skin, photosensitivity reaction, pruritus, purpura, rash, urticaria.

Urinary System

Altered micturition, urinary discoloration.

Some side effects may be serious.

Serious side effects

A serious allergic reaction is an emergency. Contact a doctor straight away if you think you or someone around you is having a serious allergic reaction.

If you experience any of the following symptoms, stop taking loratadine and call your doctor immediately:

• rash
• hives
• itching
• swelling of the eyes, face, lips, tongue, throat, hands, arms, feet, ankles, or lower legs
• hoarseness
• difficulty breathing or swallowing
• wheezing

In rare cases, loratadine may cause a serious allergic reaction.

The warning signs of a serious allergic reaction are:

• getting a skin rash that may include itchy, red, swollen, blistered or peeling skin
• wheezing
• tightness in the chest or throat
• having trouble breathing or talking
• swelling of the mouth, face, lips, tongue, or throat

These are not all the side effects of loratadine. For a full list see the leaflet inside your medicines packet.

How to cope with side effects

What to do about:

• feeling sleepy – try a different non-drowsy antihistamine. If this doesn’t help, talk to your doctor.

Human Toxicity Reports

Somnolence, tachycardia, and headache have been reported with overdoses greater than 10 mg (40 to 180 mg) ¹⁰.

Use of antihistamines is not recommended in newborn or premature infants because this age group has an increased susceptibility to anticholinergic side effects, such as central nervous system (CNS) excitation, and an increased tendency toward convulsions ¹¹. A paradoxical reaction characterized by hyperexcitability may occur in children taking antihistamines ¹¹.

Dizziness, sedation, confusion, and hypotension may be more likely to occur in geriatric patients taking antihistamines ¹¹. A paradoxical reaction characterized by hyperexcitability may occur in geriatric patients taking antihistamines. Geriatric patients are especially susceptible to the anticholinergic side effects, such as dryness of mouth and urinary retention (especially in males), of the antihistamines. If these side effects occur and continue or are severe, medication should probably be discontinued.

Loratadine overdose

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call your emergency services number.

Symptoms of loratadine overdose may include:

• fast or pounding heartbeat
• drowsiness
• headache
• unusual body movements

1. Bruttmann G, et al; J Allergy Clin Immunol 83 (2 Pt 1): 411-16; 1989 https://www.ncbi.nlm.nih.gov/pubmed/2563743[↩]
2. Powell RJ, Du Toit GL, Siddique N et al. BSACI guidelines for the management of chronic urticaria and angio-oedema. Clin Exp Allergy. 2007;37:631-50 https://www.ncbi.nlm.nih.gov/pubmed/17456211[↩][↩]
3. Hilbert J, Radwanski E, Affine MB et al. Excretion of loratadine in human breast milk. J Clin Pharmacol. 1988;28:234-9. https://www.ncbi.nlm.nih.gov/pubmed/2966185[↩][↩]
4. Merlob P, Stahl B. Prospective follow-up of adverse reactions in breast-fed infants exposed to loratadine treatment (1999-2001). BELTIS Newsl. 2002;Number 10:43-51.[↩][↩]
5. Messinis IE, Souvatzoglou A, Fais N et al. Histamine H1 receptor participation in the control of prolactin secretion in postpartum. J Endocrinol Invest. 1985;8:143-6 https://www.ncbi.nlm.nih.gov/pubmed/3928731[↩][↩]
6. Merlob P. Prospective follow-up of adverse reactions in breast-fed infants exposed to maternal loratadine treatment; 1999-2002[↩][↩]
7. Pontiroli AE, De Castro e Silva E, Mazzoleni F et al. The effect of histamine and H1 and H2 receptors on prolactin and luteinizing hormone release in humans: sex differences and the role of stress. J Clin Endocrinol Metab. 1981;52:924-8 https://www.ncbi.nlm.nih.gov/pubmed/7228996[↩]
8. PDR; Physicians’ Desk Reference. 50th Ed. Montvale, NJ: Medical Economics Co. p.2349; 1996[↩]
9. PDR; Physicians’ Desk Reference. 50th Ed. Montvale, NJ: Medical Economics Co. p.2350;1996[↩][↩]
10. PDR; Physicians’ Desk Reference. 50th Ed. Montvale, NJ: Medical Economics Co. p.2350; 1996[↩]
11. USP Convention. USPDI – Drug Information for the Health Care Professional. 16th ed. Volume I. Rockville, MD: U.S. Pharmaceutical Convention, Inc. 1996 (Plus updates)., p. 327[↩][↩][↩]

What is ibuprofen

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that is available over-the-counter to relieve pain and reduce fever. Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild to moderate pain, fever and pain caused by inflammation. Ibuprofen helps to relieve symptoms of arthritis (osteoarthritis, rheumatoid arthritis, or juvenile arthritis), such as inflammation, swelling, stiffness, and joint pain. Ibuprofen does not cure arthritis and will help you only as long as you continue to take it. In addition, ibuprofen can be used to treat fever, menstrual cramps, and other conditions as determined by your doctor.

You can buy most types of ibuprofen from pharmacies and supermarkets. Some types are only available on prescription.

Ibuprofen is available in many forms, including:

• tablets
• capsules
• liquids
• gels or creams
  sprays

In some products ibuprofen is combined with other ingredients. For example, it’s sometimes combined with medicine for a blocked nose (a decongestant) and sold as a cold and flu remedy.

Taking ibuprofen can help children feel better when they have colds or minor injuries. As with all drugs, it is important to give children the correct dose. Ibuprofen is safe when taken as directed. But taking too much of this medicine can be harmful.

Ibuprofen works by inhibiting the enzymes Cyclooxygenase 1 (COX-1) and Cyclooxygenase 2 (COX-2) by reducing hormones prostaglandin that cause inflammation, fever and pain in your body ¹. Ibuprofen reduces the ability of your body to make prostaglandins – chemicals that promote pain, inflammation and fever. With fewer prostaglandins in your body, fever eases off, and pain and inflammation is reduced. Cyclooxygenase 1 (COX-1) is constitutively active and is expressed in most tissues, including kidney, lung, stomach, duodenum, jejunum, ileum, colon, and cecum. Cyclooxygenase 1 (COX-1) functions in gastric cytoprotection, vascular homeostasis, platelet aggregation, and maintenance of normal kidney function ². Cyclooxygenase 2 (COX-2) is an inducible enzyme expressed in the brain, kidney, and possibly in the female reproductive system ². Cyclooxygenase 2 (COX-2) expression is increased during states of inflammation ³. Cyclooxygenase 2 (COX-2) is a key source of prostacyclin (PGI2) and is cardioprotective in ischemia–reperfusion injury ³. Ibuprofen analgesic activity is primarily (although not exclusively) associated with inhibition of COX-2, while different side effects result from the inhibition of COX-1 and COX-2 ⁴.

Key facts

• Ibuprofen takes 20 to 30 minutes to work if you take it by mouth.
• Ibuprofen works by reducing hormones that cause pain and swelling in the body.
• Ibuprofen is typically used for period pain or toothache. Some people find Ibuprofen better than paracetamol for back pain.
• Always take Ibuprofen tablets and capsules with food or a drink of milk to reduce the chance of an upset tummy. Don’t take it on an empty stomach.
• If you’re taking tablets, take the lowest dose for the shortest time. Don’t use it for a long time unless you’ve talked about it with your doctor.
• If you’re taking tablets, take the lowest dose for the shortest time. Don’t use it for a long time unless you’ve talked about it with your doctor. Don’t use the gel, mousse or spray for more than 2 weeks without talking to your doctor.
• Ibuprofen is called by different brand names, including Nurofen, Brufen and Calprofen (syrup), Advil, Genpril, Midol IB, Motrin IB, Proprinal, Smart Sense Children’s Ibuprofen. Ibuprofen gel can be called Fenbid, Ibugel and Ibuleve.

How long does ibuprofen take to work?

You should start to feel better 20 to 30 minutes after taking ibuprofen by mouth.

For some types of long-term pain, you’ll need to take ibuprofen regularly for up to 3 weeks for it to work properly.

If you’re applying ibuprofen to your skin, it should start to work within 1 to 2 days.

Taking ibuprofen with other painkillers

It’s safe to take ibuprofen with acetaminophen or codeine.

But don’t take ibuprofen with similar painkillers like aspirin or naproxen (Aleve) without talking to a doctor.

Ibuprofen, aspirin and naproxen belong to the same group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). If you take them together, ibuprofen plus aspirin or naproxen may increase the chance of you getting side effects like stomach ache.

Alternatives to ibuprofen

For treating fever, an alternative to ibuprofen is acetaminophen (Tylenol).

For pain or inflammation-related swelling, ask your doctor or pharmacist for an alternative if ibuprofen is not suitable for you. Your health professional may suggest you try:

• acetaminophen (paracetamol)
• another medicine from the NSAID family
• a medicine that combines codeine with acetaminophen or ibuprofen in the same tablet.

If your pain is severe, your doctor may prescribe you a stronger pain reliever.

Is ibuprofen better than acetaminophen or aspirin?

Ibuprofen, acetaminophen (paracetamol) and aspirin are all effective painkillers.

ibuprofen is good for period pain and migraines. It can also be used for back pain, strains and sprains, as well as pain from arthritis.

Acetaminophen (Tylenol) is typically used for mild or moderate pain. It may be better than ibuprofen for headaches, toothache, sprains, stomach ache, and nerve pain like sciatica.

Aspirin works in a similar way to ibuprofen. Like ibuprofen, it’s good for period pain and migraines. (If you have heavy periods, it can make them heavier.)

How long will I take ibuprofen tablets for?

If you’re taking ibuprofen for a short-lived pain like toothache or period pain, you may only need to take it for a day or two.

You may need to take ibuprofen for longer if you have a long-term health problem, such as rheumatoid arthritis.

If you need to take ibuprofen for more than 6 months, your doctor may prescribe a medicine to protect your stomach from any side effects.

Can I take ibuprofen for a long time?

It’s safe to take ibuprofen regularly for many years if you need to as long as you don’t take more than the recommended dosage.

If you need to take ibuprofen by mouth for a long time and you’re at risk of getting a stomach ulcer, your doctor may prescribe a medicine to help protect your stomach.

Does ibuprofen cause stomach ulcers?

Ibuprofen can cause ulcers in your stomach or gut, especially if you take it by mouth for a long time or in big doses.

If you need to take ibuprofen and you’re at risk of getting a stomach ulcer, your doctor may prescribe a medicine to help protect your stomach.

Can I drink alcohol with ibuprofen?

It’s usually safe to drink alcohol while taking ibuprofen. But if you’re taking ibuprofen by mouth, drinking too much alcohol may irritate your stomach and increases your risk of getting stomach ulcers.

Is there any food or drink I need to avoid?

You can eat and drink normally while taking any type of ibuprofen.

It’s best to take ibuprofen tablets, capsules or syrup with, or just after, a meal so it doesn’t upset your stomach. Don’t take it on an empty stomach.

What if ibuprofen doesn’t work?

If ibuprofen doesn’t work, there are other everyday painkillers you can try, such as:

• acetaminophen (paracetamol)
• aspirin
• co-codamol (acetaminophen combined with low-dose codeine)

If pharmacy painkillers don’t work, your doctor may be able to prescribe a stronger painkiller or recommend another treatment, such as exercise or physiotherapy.

Ibuprofen doesn’t work for certain types of pain – for example, nerve pain like sciatica. Your doctor will have to prescribe a different medicine if your pain is related to your nerves.

Will ibuprofen affect my fertility?

Taking ibuprofen by mouth, in large doses, or for a long time can affect ovulation in women, possibly making it more difficult for you to get pregnant. This is usually reversible when you stop taking ibuprofen.

Don’t take ibuprofen tablets, capsules or syrup if you’re trying for a baby. Acetaminophen (Paracetamol) is a better option.

Will ibuprofen affect my contraception?

Ibuprofen – by mouth or on your skin – doesn’t affect any contraceptives, including the contraceptive pill and the morning after pill.

Who can and can’t take ibuprofen

Some brands of ibuprofen tablets, capsules and syrup contain aspartame, colors, gelatin, glucose, lactose, sodium, sorbitol, soya or sucrose, so they may be unsuitable for some people.

Don’t take ibuprofen by mouth or apply it to your skin if you:

• have had an allergic reaction to ibuprofen or any other medicines in the past
• have previously had a reaction, such as asthma, a raised, itchy red rash (urticaria), swelling underneath your skin (angioedema) or swelling of the inside of your nose (rhinitis)
• have taken aspirin or any other NSAID
• have asthma or another allergic illness
• are trying to get pregnant, are already pregnant or if you’re breastfeeding

To make sure ibuprofen (by mouth or on your skin) is safe for you, tell your doctor or pharmacist if you have:

• had bleeding in your stomach, a stomach ulcer, or a perforation (a hole) in your stomach
• a health problem that means you have an increased chance of bleeding
• liver problems, such as liver fibrosis, cirrhosis or liver failure
• heart disease or severe heart failure
• kidney failure
• Crohn’s disease or ulcerative colitis
• chickenpox or shingles – taking ibuprofen can increase the chance of certain infections and skin reactions

Cautions with other medicines

Ibuprofen doesn’t mix well with some medicines.

Ibuprofen applied to the skin is less likely to interfere with other medicines than if it’s taken by mouth.

For safety, tell your doctor if you’re taking these medicines before you start taking ibuprofen by mouth or on your skin:

• blood-thinning medicines such as warfarin
• anti-inflammatory painkillers such as aspirin, diclofenac, mefenamic acid and naproxen
• medicines for high blood pressure
• steroid medicines such as betamethasone, dexamethasone, hydrocortisone or prednisolone
• antibiotics such as ciprofloxacin, levofloxacin, moxifloxacin, nalidixic acid, norfloxacin or ofloxacin
• antidepressants such as citalopram, fluoxetine, fluvoxamine, venlafaxine, paroxetine or sertraline
• diabetes medicines such as gliclazide, glimepiride, glipizide and tolbutamide

Pregnancy and breastfeeding

Ibuprofen isn’t normally recommended in pregnancy.

It may cause birth defects affecting the baby’s heart or blood vessels. There may also be a link between taking ibuprofen in early pregnancy and miscarriage.

Acetaminophen (paracetamol) is the best painkiller to take during pregnancy.

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Ibuprofen may be harmful to an unborn baby. Taking ibuprofen during the last 3 months of pregnancy may result in birth defects and prolonged labor and delivery. Do not use this medicine without a doctor’s advice if you are pregnant.

Use in late pregnancy should be avoided. May constrict ductus arteriosus in utero or inhibit or prolong labor as result of inhibition of prostaglandin synthetase ⁵.

For safety, tell your pharmacist or doctor if you’re trying to get pregnant, are already pregnant or if you’re breastfeeding.

To assess the fetal effects of exposure to ibuprofen overdose in pregnancy ⁶. Ibuprofen, a non-steroidal anti-inflammatory drug (NSAID) is a frequently used analgesic that is readily available over the counter. Concerns have been raised that therapeutic use of NSAIDs is associated with an increased risk of miscarriage and renal dysfunction. Although most acute overdoses are of low toxicity, few data exist on the potential fetotoxicity of ibuprofen overdose during pregnancy. Using standardized procedures, National Technical Information Service (NTIS) has provided fetal risk assessment and collected outcome data on a prospective case series of 100 women who took ibuprofen in overdose during pregnancy. Results are the majority of liveborn infants (66/73=90.4%) had no congenital anomalies. No pattern of anomalies was observed. Multidrug overdoses in which ibuprofen was the major constituent were taken by 68%, mainly compound analgesics and cold remedies with 28% taking paracetamol. The majority (86%) of overdoses occurred in the first trimester with only 9 (9%) reports of any significant maternal toxicity including 1 mother who was unconscious. Conclusion: The incidence of miscarriages (9% versus 10-20%) and terminations (18% versus 23%) is within the expected range ⁶. However, the incidence of congenital anomalies is higher (7/73=9.6% versus 2-3% expected), but two exposures were second trimester, and the numbers are small. Although no pattern of malformations was seen, three were cardiac anomalies ⁶. As congenital heart anomalies are common 0.5-1% it is not possible to establish a causal relationship with the drugs taken in overdose. No cases of renal dysfunction were seen. In the majority of women who receive appropriate treatment at the time of the overdose the outcome of pregnancy is a normal baby ⁶.
ibuprofen and breastfeeding

Ibuprofen is safe to take by mouth if you are breastfeeding. Ibuprofen appears in breast milk in small amounts, so it’s unlikely to cause any harm to your baby while you’re breastfeeding.

Two early studies attempted measurement of ibuprofen in milk ⁷, ⁸. In one, the patient’s dose was 400 mg twice daily, while in the second study of 12 patients, the dose was 400 mg every 6 hours. Ibuprofen was undetectable in breastmilk in both studies (<0.5 and 1 mg/L, respectively) ⁷, ⁸.

A later study using a more sensitive assay found ibuprofen in the breastmilk of one woman who took 6 doses of 400 mg orally over a 42.5 hours. A milk ibuprofen level of 13 mcg/L was detected 30 minutes after the first dose. The highest level measured was 180 mcg/L about 4 hours after the third dose, 20.5 hours after the first dose. The authors estimated that the infant would receive about 17 mcg/kg daily (100 mcg daily) with the maternal dose of approximately 1.2 grams daily. This dose represents 0.0008% of the maternal weight-adjusted dosage ⁹ and 0.06% of the commonly accepted infant dose of 30 mg/kg daily (10 mg/kg every 8 hours).

Single milk samples were taken from 13 women between 1.5 and 8 hours after the third dose of ibuprofen in a daily dosage regimen averaging 1012 mg daily (range 400 to 1200 mg daily). Of the 13 milk samples analyzed, the mean milk concentration was 361 mcg/L (range 164 to 590 mcg/L). The mean weight-adjusted percentage of the maternal dosage (relative infant dosage) was estimated to be <0.38%; however, the relative infant dosage varied with the time postpartum and the milk protein content. The relative infant dosage was highest in the colostral phase when the milk protein content was the highest (relative infant dosage 0.6%). The estimated mean dosage for a fully breastfed infants was 68 mcg/kg daily or 0.2% of a pediatric dosage ¹⁰.

Ibuprofen and children

Ibuprofen may be given to children aged three months or over who weigh at least 5kg (11lbs) to relieve pain, inflammation or fever. Ibuprofen treats inflammation, such as aches and pains after an injury like a sprain, or because of a health problem like childhood arthritis.

Your doctor or another healthcare professional may recommend ibuprofen for younger children in certain cases – for example, this may be to control a fever after a vaccination if paracetamol is unsuitable.

If your baby or child has a high temperature that doesn’t get better or they continue to experience pain, speak to your doctor.

For younger children, ibuprofen comes as a syrup that you swallow.

For older children, ibuprofen is available as tablets, capsules and granules that you dissolve in water to make a drink.

You can buy most types of ibuprofen from pharmacies and supermarkets. Some types, such as ibuprofen granules, are only available on prescription.

Ibuprofen:

• syrup can be given to children over 3 months of age
• tablets and capsules can be given to children aged 6 or older
• chewable tablets can be given to children aged 7 or older
• granules can be given to children aged 12 or older

Key facts

• Your child should start to feel better about 20 to 30 minutes after taking ibuprofen.
• Ibuprofen comes in a range of different strengths. The right dose for your child depends on their age. Always leave 4 to 6 hours between doses.
• It’s best to give ibuprofen with or just after a meal so it doesn’t upset your child’s stomach. Don’t give it on an empty stomach.
• Do not give ibuprofen to your child if they have asthma, unless your doctor has said it’s ok.

Ibuprofen isn’t suitable for some children. Check with your doctor or pharmacist if your child:

• has had an allergic reaction to ibuprofen or any other medicines in the past
• has chicken pox – taking ibuprofen can cause severe skin reactions
• has asthma
• has liver or kidney problems
• has a health problem that means they have an increased risk of bleeding
• has an inflammatory bowel disease, such as Crohn’s disease or ulcerative colitis

Ibuprofen uses

Prescription ibuprofen is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints) and rheumatoid arthritis (arthritis caused by swelling of the lining of the joints). Ibuprofen is also used to relieve mild to moderate pain, including menstrual pain (pain that happens before or during a menstrual period). Nonprescription ibuprofen is used to reduce fever and to relieve minor aches and pain from headaches, muscle aches, arthritis, menstrual periods, the common cold, toothaches, and backaches.

Ibuprofen is usually taken three or four times a day for arthritis or every 4 to 6 hours as needed for pain. Nonprescription ibuprofen comes as a tablet, chewable tablet, suspension (liquid), and drops (concentrated liquid). Adults and children older than 12 years of age may usually take nonprescription ibuprofen every 4 to 6 hours as needed for pain or fever. Children and infants may usually be given nonprescription ibuprofen every 6 to 8 hours as needed for pain or fever, but should not be given more than 4 doses in 24 hours. Ibuprofen may be taken with food or milk to prevent stomach upset. If you are taking ibuprofen on a regular basis, you should take it at the same time(s) every day. Follow the directions on the package or prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take ibuprofen exactly as directed. Do not take more or less of it or take it more often than directed by the package label or prescribed by your doctor.

Ibuprofen comes alone and in combination with other medications. Some of these combination products are available by prescription only, and some of these combination products are available without a prescription and are used to treat cough and cold symptoms and other conditions. If your doctor has prescribed a medication that contains ibuprofen, you should be careful not to take any nonprescription medications that also contain ibuprofen.

If you are selecting a product to treat cough or cold symptoms, ask your doctor or pharmacist for advice on which product is best for you. Check nonprescription product labels carefully before using two or more products at the same time. These products may contain the same active ingredient(s) and taking them together could cause you to receive an overdose. This is especially important if you will be giving cough and cold medications to a child.

Nonprescription cough and cold combination products, including products that contain ibuprofen, can cause serious side effects or death in young children. Do not give these products to children younger than 4 years of age. If you give these products to children 4 to 11 years of age, use caution and follow the package directions carefully.

If you are giving ibuprofen or a combination product that contains ibuprofen to a child, read the package label carefully to be sure that it is the right product for a child of that age. Do not give ibuprofen products that are made for adults to children.

Before you give an ibuprofen product to a child, check the package label to find out how much medication the child should receive. Give the dose that matches the child’s age on the chart. Ask the child’s doctor if you don’t know how much medication to give the child.

Shake the suspension and drops well before each use to mix the medication evenly. Use the measuring cup provided to measure each dose of the suspension, and use the dosing device provided to measure each dose of the drops.

The chewable tablets may cause a burning feeling in the mouth or throat. Take the chewable tablets with food or water.

Stop taking nonprescription ibuprofen and call your doctor if your symptoms get worse, you develop new or unexpected symptoms, the part of your body that was painful becomes red or swollen, your pain lasts for more than 10 days, or your fever lasts more than 3 days. Stop giving nonprescription ibuprofen to your child and call your child’s doctor if your child does not start to feel better during the first 24 hours of treatment. Also stop giving nonprescription ibuprofen to your child and call your child’s doctor if your child develops new symptoms, including redness or swelling on the painful part of his body, or if your child’s pain or fever get worse or lasts longer than 3 days.

Do not give nonprescription ibuprofen to a child who has a sore throat that is severe or does not go away, or that comes along with fever, headache, nausea, or vomiting. Call the child’s doctor right away, because these symptoms may be signs of a more serious condition.

Other uses for ibuprofen

Ibuprofen is also sometimes used to treat ankylosing spondylitis (arthritis that mainly affects the spine), gouty arthritis (joint pain caused by a build-up of certain substances in the joints), and psoriatic arthritis (arthritis that occurs with a long-lasting skin disease that causes scaling and swelling). Talk to your doctor about the risks of using this drug for your condition.

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking ibuprofen

• Tell your doctor and pharmacist if you are allergic to ibuprofen, aspirin or other NSAIDs such as ketoprofen and naproxen (Aleve, Naprosyn), any other medications, or any of the inactive ingredients in the type of ibuprofen you plan to take. Ask your pharmacist or check the label on the package for a list of the inactive ingredients.

• Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin, in Lotrel), captopril, enalapril (Vasotec, in Vaseretic), fosinopril, lisinopril (in Zestoretic), moexipril (Univasc), perindopril (Aceon, in Prestalia), quinapril (Accupril, in Quinaretic), ramipril (Altace), and trandolapril (Mavik, in Tarka); angiotensin receptor blockers such as candesartan (Atacand, in Atacand HCT), eprosartan (Teveten), irbesartan (Avapro, in Avalide), losartan (Cozaar, in Hyzaar), olmesartan (Benicar, in Azor, in Benicar HCT, in Tribenzor), telmisartan (Micardis, in Micardis HCT, in Twynsta), and valsartan (in Exforge HCT); beta blockers such as atenolol (Tenormin, in Tenoretic), labetalol (Trandate), metoprolol (Lopressor, Toprol XL, in Dutoprol), nadolol (Corgard, in Corzide), and propranolol (Hemangeol, Inderal, Innopran); diuretics (‘water pills’); lithium (Lithobid); and methotrexate (Otrexup, Rasuvo, Trexall). Your doctor may need to change the doses of your medications or monitor you more carefully for side effects.

• DO NOT take nonprescription ibuprofen with any other medication for pain unless your doctor tells you that you should.

• Tell your doctor if you have or have ever had any of the conditions mentioned in the IMPORTANT WARNING section or asthma, especially if you also have frequent stuffed or runny nose or nasal polyps (swelling of the inside of the nose); heart failure; swelling of the hands, arms, feet, ankles, or lower legs; lupus (a condition in which the body attacks many of its own tissues and organs, often including the skin, joints, blood, and kidneys); or liver or kidney disease. If you are giving ibuprofen to a child, tell the child’s doctor if the child has not been drinking fluids or has lost a large amount of fluid from repeated vomiting or diarrhea.

• Tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy; you plan to become pregnant; or you are breast-feeding. If you become pregnant while taking ibuprofen, call your doctor.

• If you are having surgery, including dental surgery, tell the doctor or dentist that you are taking ibuprofen.

• If you have phenylketonuria (PKU, an inborn disease in which mental retardation develops if a specific diet is not followed), read the package label carefully before taking nonprescription ibuprofen. Some types of nonprescription ibuprofen may be sweetened with aspartame, a source of phenylalanine.

Important reminders:

• When taking any medicine, always read and follow the label carefully.
• Always keep the outer carton of ibuprofen products.
• These ibuprofen dosage directions are for adults and children 12 years and older.
• Do not take more than directed.

Ibuprofen dosage

Applies to the following ibuprofen strengths: 100 mg/5 mL; 800 mg; 300 mg; 600 mg; 400 mg; 200 mg; 50 mg/1.25 mL; 50 mg; 100 mg; 10 mg/mL; 100 mg/mL

Usual Adult Dose for Dysmenorrhea

200 to 400 mg orally every 4 to 6 hours as needed

• Maximum dose: 3200 mg/day (prescription strength); 1200 mg/day (over-the-counter)
  

Comment:

• Treatment should begin at the earliest onset of pain.

Use: For the relief of signs and symptoms of primary dysmenorrhea

Usual Adult Dose for Osteoarthritis

1200 to 3200 mg orally per day in divided doses

Maximum dose: 3200 mg/day

Comments:

• Patients with rheumatoid arthritis may require higher doses than those with osteoarthritis.
• Once response to therapy is determined, dose and frequency should be adjusted to the lowest effective dose for the shortest duration possible to suit the individual patient’s treatment goals.
• Patients treated with 3200 mg orally per day should be observed for sufficient increased clinical benefits to offset potential increased risk.

Use: For the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis

Usual Adult Dose for Rheumatoid Arthritis

1200 to 3200 mg orally per day in divided doses

• Maximum dose: 3200 mg/day

Comments:

• Patients with rheumatoid arthritis may require higher doses than those with osteoarthritis.
• Once response to therapy is determined, dose and frequency should be adjusted to the lowest effective dose for the shortest duration possible to suit the individual patient’s treatment goals.
• Patients treated with 3200 mg orally per day should be observed for sufficient increased clinical benefits to offset potential increased risk.

Use: For the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis

Usual Adult Dose for Pain

Ibuprofen Oral:

200 to 400 mg orally every 4 to 6 hours as needed

Maximum dose: 3200 mg/day (prescription strength); 1200 mg/day (over-the-counter)

Comment:

• Oral doses greater than 400 mg have not been shown to be any more effective than the 400 mg dose.

Use: For the relief of mild to moderate pain

Usual Adult Dose for Fever

Ibuprofen Oral:

Initial dose: 200 mg orally every 4 to 6 hours

May increase to 400 mg every 4 to 6 hours if additional relief is needed

Maximum dose: 1200 mg/day

Use: For the reduction of fever

Usual Pediatric Dose for Fever

Ibuprofen Oral Suspension (Infant drops: 50 mg/1.25 mL):

• 6 to 11 months; 12 to 17 pounds: 50 mg (1.25 mL) every 6 to 8 hours as needed
• 12 to 23 months; 18 to 23 pounds: 75 mg (1.875 mL) orally every 6 to 8 hours as needed

Maximum dose: 4 doses per day

Oral Suspension (100 mg/5 mL):
6 months to 2 years:

• Baseline temperature less than 102.5 °F (39.2 °C): 5 mg/kg orally every 6 to 8 hours
• Baseline temperature 102.5 °F (39.2 °C) or greater: 10 mg/kg orally every 6 to 8 hours
• Maximum dose: 40 mg/kg/day

2 to 11 years: 5 to 10 mg/kg orally every 6 to 8 hours as needed

• Maximum dose: 40 mg/kg/day or 4 doses per day

Oral Chewable Tablets:
2 to 11 years: 5 to 10 mg/kg every 6 to 8 hours as needed
-Maximum dose: 40 mg/kg/day or 4 doses per day

Oral Capsules and Tablets:
12 years and older:
-Initial dose: 200 mg orally every 4 to 6 hours as needed
-May increase to 400 mg every 4 to 6 hours if additional analgesia is needed
Maximum dose: 1200 mg/day

Comment:
-There are multiple over-the-counter formulations with different concentrations of the oral suspension and capsule/tablet strengths; manufacturer labeling may be consulted for weight/age based dosing charts.

Use: For the relief of fever

Usual Pediatric Dose for Pain

Ibuprofen Oral Suspension (Infant drops: 50 mg/1.25 mL):
6 to 11 months; 12 to 17 pounds: 50 mg (1.25 mL) every 6 to 8 hours as needed
12 to 23 months; 18 to 23 pounds: 75 mg (1.875 mL) orally every 6 to 8 hours as needed
-Maximum dose: 4 doses per day

Oral Suspension (100 mg/5 mL):
6 months to 2 years: 10 mg/kg orally every 6 to 8 hours
-Maximum dose: 40 mg/kg/day

2 to 11 years: 5 to 10 mg/kg orally every 6 to 8 hours
-Maximum dose: 40 mg/kg/day or 4 doses per day

Oral Chewable Tablets:
2 to 11 years: 5 to 10 mg/kg every 6 to 8 hours as needed
-Maximum dose: 40 mg/kg/day or 4 doses per day

Oral Capsules and Tablets:
12 years or older:
Initial dose: 200 mg orally every 4 to 6 hours as needed
-May increase to 400 mg every 4 to 6 hours if additional analgesia is needed
Maximum dose: 1200 mg/day

Comment:
-There are multiple over-the-counter formulations with different concentrations of the oral suspension and capsule/tablet strengths; manufacturer labeling may be consulted for weight/age based dosing charts.

Use: For the relief of mild to moderate pain

Usual Pediatric Dose for Juvenile Rheumatoid Arthritis

Oral Suspension (100 mg/5 mL):
6 months or older: 30 to 40 mg/kg/day orally in 3 to 4 divided doses; milder disease may use 20 mg/kg/day
-Maximum dose: 40 mg/kg/day

Comments:

• Doses greater than 40 mg/kg/day may increase risk of serious adverse effects; doses greater than 50 mg/kg/day have not been studied and are not recommended.
• With doses above 30 mg/kg/day or in patients with a history of abnormal liver function tests with previous NSAID therapy, closely monitor for signs/symptoms of early liver dysfunction.
• Therapeutic response may not be achieved for a few days or several weeks; the dosage should be lowered to the lowest effective dose once clinical effect is achieved.

Use: For the relief of signs and symptoms of juvenile rheumatoid arthritis

Usual Pediatric Dose for Patent Ductus Arteriosus

Ibuprofen lysine (NeoProfen[R]):
Gestational age 32 weeks or less and weight between 500 and 1500 g:
-Initial dose: 10 mg/kg IV
-Following initial dose, two doses of 5 mg/kg each, after 24 and 48 hours
-If anuria or marked oliguria (urinary output less than 0.6 mL/kg/hr) is evident at time of the second or third dose, hold drug until laboratory studies indicate renal function has returned to normal.

Comments:
-A course of therapy is defined as 3 doses; if ductus arteriosus closes or has significantly reduced in size after completion of the first course, no further doses are needed.
-If during continued medical management the ductus arteriosus fails to close or reopens, then a second course, alternative pharmacological therapy, or surgery may be needed.

Use: For the closure of a clinically significant patent ductus arteriosus (PDA) in premature infants weighing between 500 and 1500 g, who are no more than 32 weeks gestational age when usual medical management is ineffective (e.g., fluid restriction, diuretics, respiratory support, etc.). The clinical trial was conducted in infants with asymptomatic PDA; however, the consequences beyond 8 weeks after treatment have not been evaluated; therefore, treatment should be reserved for infants with clear evidence of a clinically significant PDA.

Renal Dose Adjustments

• Advanced Renal Disease: Not recommended; if treatment is necessary, close monitoring of renal function is advised.
• Neonates: If anuria or marked oliguria (urinary output less than 0.6 mL/kg/hr) occurs after a dose of IV therapy, no additional doses should be given until renal function returns to normal.

Liver Dose Adjustments

• Patients who have an abnormal liver test or who develop signs or symptoms of liver dysfunction should be evaluated for hepatic dysfunction.
• If liver disease develops or if systemic manifestations such as eosinophilia or rash occur, this drug should be discontinued.
• Pediatric: With doses above 30 mg/kg/day or in patients with a history of abnormal liver function tests with previous NSAID therapy, closely monitor for signs/symptoms of early liver dysfunction.

How much ibuprofen can I take?

The usual dose for adults is one or two 200mg tablets 3 times a day. If this isn’t enough, your doctor may prescribe a higher dose of up to 600mg to take 4 times a day.

If you take ibuprofen 3 times a day, leave at least 6 hours between doses. If you take it 4 times a day, leave at least 4 hours between doses.

If you have pain all the time, your doctor may recommend slow-release ibuprofen tablets or capsules. It’s usual to take these once a day in the evening or twice a day. Leave a gap of 10 to 12 hours between doses if you’re taking ibuprofen twice a day.

For people who find it difficult to swallow tablets or capsules, ibuprofen is available as a tablet that melts in your mouth, granules that you mix with a glass of water to make a drink, and as a syrup.

Swallow ibuprofen tablets or capsules whole with a glass of water or juice. Don’t chew, break, crush or suck them as this could irritate your mouth or throat.

Always take ibuprofen tablets and capsules after a meal or snack or with a drink of milk. It will be less likely to upset your tummy.

What if I forget to take ibuprofen?

Take the missed dose as soon as you remember, unless it’s almost time for your next dose. In this case, skip the missed dose and take your next dose as normal.

Never take a double dose to make up for a forgotten one.

If you forget doses often, it may help to set an alarm to remind you. You could also ask your pharmacist for advice on other ways to help you remember to take your medicine.

What if I take too much ibuprofen?

Taking too much ibuprofen by mouth can be dangerous. It can cause side effects such as:

• feeling sick and vomiting
• tummy pain
• feeling tired or sleepy
• black stool and blood in your vomit – a sign of bleeding in your stomach
• tinnitus (ringing in your ears)
• difficulty breathing or changes in your heart rate (slower or faster)

How and when to give ibuprofen to children

Ibuprofen is usually given to children 3 or 4 times a day. Your pharmacist or doctor will tell you how often to give it.

If you give ibuprofen:

• 3 times in 24 hours, leave at least 6 hours between doses
• 4 times in 24 hours, leave at least 4 hours between doses

How much ibuprofen to give to children

Ibuprofen syrup dosages for children (5ml equals 100mg)

Ibuprofen tablet dosages for children

If your child has pain all the time, your doctor may prescribe slow-release tablets or capsules. These are given once or twice a day.

It’s best to give ibuprofen to children with food or milk so they don’t get an upset tummy.

If you’re not sure how much to give a child, ask your pharmacist or doctor.

How to give ibuprofen to a child

It’s best to give ibuprofen with or just after a meal so it doesn’t upset your child’s stomach. Don’t give it on an empty stomach.

Syrup

Shake the bottle well and measure out the right amount using a plastic syringe or spoon. These come in the medicine packet. If you don’t have a syringe or spoon, ask your pharmacist for one. Don’t use a kitchen teaspoon as it won’t give the right amount.

To hide the taste of the syrup, you can give the child a drink of milk or fruit juice straight after the medicine. But don’t mix ibuprofen syrup with juice or milk as it may mean they don’t get the right dose.

Tablets and capsules

Tablets and capsules should be swallowed whole with a glass of water or juice. Tell your child not to chew, break, crush or suck them as this could irritate their mouth or throat.

Children taking chewable tablets should chew them before swallowing.

Granules

Sprinkle or stir the granules into a small amount of soft food (such as yoghurt) or a small drink, or you can mix them with a spoonful of cold water. Don’t mix the granules with warm food or liquid. Your child should then swallow the food or drink it straight away without chewing. Make sure they take it all. Don’t keep the granule/food mixture to give later.

What if my child vomits?

If your child vomits less than 30 minutes after having a dose of ibuprofen, give them the same dose again.

If your child vomits more than 30 minutes after having a dose of tablets of ibuprofen, you do not need to give them another dose. Wait until the next normal dose.

What if I forget to give it?

Give the missed dose as soon as you remember, unless it’s almost time for their next dose. In this instance, skip the missed dose and give their next dose as usual.

Never give a double dose to make up for a forgotten one.

What if they take too much?

Giving your child too much ibuprofen by accident can be dangerous.

If you think you may have given your child an extra dose of ibuprofen by mistake, wait at least 12 hours before giving them any more.

• If your child has had more than a double dose of ibuprofen, take them your nearest hospital accident and emergency department straight away.

If your child needs to go to hospital, take the ibuprofen packet or leaflet inside it plus any remaining medicine with them.

Giving ibuprofen with other painkillers

The only safe painkiller to give to children alongside ibuprofen is paracetamol (such as Tylenol).

Do not give ibuprofen and paracetamol together, though. Instead, if you’ve given ibuprofen to your child and they’re still feverish or in pain when the next dose is due, you could try paracetamol instead.

Don’t take more than the maximum daily dose of either medicine. See your doctor if you’ve tried both ibuprofen and paracetamol and they haven’t helped.

Never give aspirin to a child under the age of 16 (unless prescribed by a doctor).

Is acetaminophen or ibuprofen better?

Ibuprofen and acetaminophen are both effective painkillers, but they work in different ways. They can both bring down a fever (38 °C or above). Ibuprofen may be better for some types of pain than paracetamol.

Ibuprofen is typically used for teething and toothache. It’s also better for swelling, and aches and pains after an injury like a sprain.

Ibuprofen side effects in children

Ibuprofen can cause side effects. To reduce the chance of side effects, give your child the lowest dose for the shortest time to control their symptoms.

Common side effects

The common side effects of ibuprofen, which happen in more than 1 in 100 children, are:

• stomach pain
• indigestion
• heartburn

Your child may also feel sick or vomit. You can help reduce the chances of this by giving ibuprofen with food.

If these symptoms carry on or get worse, they may be signs of irritation of the gut or stomach. Talk to your doctor or pharmacist if these side effects bother your child or don’t go away.

Your child may also get diarrhea, or they may hear ringing in their ears.

Serious side effects

• If your child gets bad stomach pains, vomits blood, or their poo is very dark or black, contact your doctor or take your child to hospital straight away as they may have a stomach ulcer.
• Ibuprofen may make asthma worse in some children, but this is uncommon. Contact your doctor if you’re worried.
• If your child stops peeing or there’s blood in their pee, contact your doctor straight away. There may be a problem with their kidneys.

Serious allergic reaction

In rare cases, it’s possible for your child to have a serious allergic reaction to ibuprofen.

• A serious allergic reaction is an emergency. Take your child to hospital or call an ambulance straight away.

The warning signs of a serious allergic reaction are:

• getting a skin rash that may include itchy, red, swollen, blistered or peeling skin
• wheezing
• tightness in the chest or throat
• having trouble breathing or talking
• swelling of the mouth, face, lips, tongue, or throat

These are not all the side effects of ibuprofen. For a full list see the leaflet inside your medicines packet.

Ibuprofen side effects

Common side effects

The common side effects of ibuprofen taken by mouth happen in more than 1 in 100 people. Talk to your doctor or pharmacist if these side effects bother you or don’t go away:

• headache
• feeling dizzy
• feeling sick or vomiting
• wind and indigestion
• upset stomach e.g. nausea, diarrhea and indigestion
• headache
• dizziness
• high blood pressure
• fluid retention.

There can be extra risks if you take ibuprofen when you are over 65, or have an ulcer, so discuss this with your doctor. Ibuprofen, like all NSAIDs, can also make heart disease worse – talk to your doctor before taking ibuprofen if you have any concerns.

Less common side effects include:

• feeling sleepy or anxious
• pins and needles
• problems with your eyesight
• hearing ringing in your ears
• difficulty falling asleep

Ibuprofen tablets and capsules can cause inflammation of the stomach (gastritis) and ulcers in your stomach, gut or mouth. It can also make it difficult to breathe, or make asthma worse.

Serious side effects

Serious side effects of ibuprofen that need immediate medical attention include:

• black poo or blood in your vomit – these can be signs of bleeding in your stomach
• swollen ankles, blood in your pee or not peeing at all – these can be signs of a kidney problem
• severe chest or tummy pain – these can be signs of a hole in your stomach or gut
• difficulty breathing

This is not a full list of side effects. For more information, talk to your doctor or pharmacist. Or, if you’re experiencing a serious or life-threatening side effect, immediately call your local emergency number immediately.

Serious allergic reaction

In rare cases, it’s possible to have a serious allergic reaction to ibuprofen.

• A serious allergic reaction is an emergency. Call your local emergency number straight away if you think you or someone around you is having a serious allergic reaction.

The warning signs of a serious allergic reaction are:

• getting a skin rash that may include itchy, red, swollen, blistered or peeling skin
• wheezing
• tightness in the chest or throat
• having trouble breathing or talking
• swelling of the mouth, face, lips, tongue, or throat

These are not all the side effects of ibuprofen tablets, capsules and syrup. For a full list see the leaflet inside your medicines packet.

How to cope with side effects

What to do about:

• indigestion – stop taking ibuprofen and see your doctor as soon as possible. If you need something to ease the discomfort, try taking an antacid, but don’t put off going to the doctor.
• feeling sick – stick to simple meals. Don’t eat rich or spicy food
• vomiting – have small, frequent sips of water. It may also help to take oral rehydration solutions like Pedialyte you can buy from a pharmacy or supermarket to prevent dehydration. Don’t take any other medicines to treat vomiting without speaking to a pharmacist or doctor.
• wind – try not to eat foods that cause wind (like pulses, lentils, beans and onions). Eat smaller meals, eat and drink slowly, and exercise regularly. There are pharmacy medicines that can also help, such as charcoal tablets or simethicone.
• your skin being sensitive to sunlight – stay out of bright sun and use a high factor sun cream (SPF 30 or above) even on cloudy days. Don’t use a sun lamp or sun beds.

Human Toxicity Reports

Gastrointestinal side effects are experienced by 5-15% of patients taking ibuprofen; epigastric pain, nausea, heartburn and sensations of “fullness” in the gastrointestinal tract are the usual difficulties ¹¹. However, the incidence of theses side effects is less with ibuprofen than with aspirin or indomethacin. Other side effects of ibuprofen have been reported less frequently. They include thrombocytopenia, skin rashes, headache, dizziness and blurred vision and in a few cases, toxic amblyopia, fluid retention and edema ¹¹.

Fatal autoimmune hemolytic anemai occurred coincident with oral administration of ibuprofen 400 mg 3 times per day in 49 yr old male ¹².

Healthy subjects treated for 2 weeks with 3 times daily ibuprofen showed a total blood loss of 9.7 ml. Mean daily blood loss was significantly higher than on placebo ¹³.

In ibuprofen overdose cases, the majority of patients had no symptoms or only mild symptoms such as nausea or vomiting. Lab analyses available for some cases demonstrate that plasma ibuprofen concentrations of up to 704 mg/L could be associated with no symptoms ¹⁴.

A case of aseptic meningoencephalitis induced by ibuprofen (Brufen) is decribed in a 24 year old unmarried woman with unrecognized systemic lupus erythematosus. The neurological manifestations induced by ibuprofen revealed the systemic disease. Clinicians confronted with aseptic meningitis or meningoencephalitis developed after treatment with a non-steroidal anti-inflammatory drug, notably ibuprofen, should investigate for systemic disease ¹⁵.

Ibuprofen (Motrin, Brufen) an anti inflammatory phenylpropionic derivative, was reported in 1971 to have caused reversible centrocecal field defects and reduced visual acuity in two patients, and a reversible “moving mosaic of colored lights in front of both eyes” in another ¹⁶. One patient was reported to have a drastic impairment of color vision & decr in visual acuity, which were largely reversible on discontinuing ibuprofen. Another patient on 2 occasions after taking ibuprofen has complained of seeing streaks shooting from lateral to central field of vision; eye exams were normal ¹⁶. Cortical visual evoked potentials were evaluated in a patient who had 20/50, 20/60 vision with decreased brightness of colors after taking ibuprofen for 2 months, showing decreased amplitudes & increased conduction times, but these became normal 6 days after the drug was stopped; vision became normal later ¹⁶.

In a series of 293 patients treated during a five year period no visual symptoms were detected that were thought attributable to the drug ¹⁶ and in another series of 247 patients there was no evidence of toxic amblyopia or maculopathy attributable to ibuprofen. A prospective study in 1975 reported no evidence of eye toxicity in 45 healthy volunteers treated for 3 months, or in 78 patients with osteoarthritis during 6 months ¹⁶.

Chemically induced renal dysfunction caused by ibuprofen is dose/duration related ¹⁷. Most common presentation renal insufficiency that can lead to acute or chronic renal failure. Cell-mediated nephrotic syndrome can occur. Short term use of moderate dose ibuprofen may result in /acute renal failure/ in patients with asymptomatic mild chronic renal failure.

Prostaglandins are known to be involved in the metabolism of bone, having a significant influence on bone resorption in cases of bone pathology ¹⁸. This study ¹⁸ investigated the short-term effects of two commonly used nonsteroidal anti-inflammatory drugs (NSAIDs), ibuprofen and acetaminophen (paracetamol), on bone resorption in healthy men. In a randomized, double-blind pilot study, 28 healthy, age- and weight-matched male volunteers were treated with ibuprofen (n = 10), acetaminophen (n = 9), or a placebo (n = 9) for 3 days. As an indication of bone resorption rate, levels of the biochemical bone markers N-telopeptide (NTx) and free deoxypyridinoline (D-Pyr) were measured in urine. Differences in resorption marker levels pre- and post-NSAID use were then compared between groups. The study authors ¹⁸ found that NTx concentrations in the acetaminophen group were lower than placebo, whereas NTx levels in the ibuprofen group were higher than in the acetaminophen group. By contrast, D-Pyr concentrations in the ibuprofen group were significantly lower than in the placebo group (p = 0.009). A comparison of the percentage changes of D-Pyr:NTx ratios found that the ratio in the ibuprofen group was significantly lower than that of both the control and acetaminophen groups. These results show the differential effects of ibuprofen and acetaminophen on urinary excretion of peptide-bound and free deoxypyridinoline cross-links of type I collagen. Short-term ibuprofen use may alter the renal handling of collagen cross-links and increase bone resorption to a greater extent than acetaminophen in normal men ¹⁸.

Ibuprofen overdose

Can you overdose on ibuprofen? Yes

In case of ibuprofen overdose

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call your local emergency services number.

This is a free and confidential service. All local poison control centers in the United States use this national number. You should call if you have any questions about poisoning or poison prevention. You can call 24 hours a day, 7 days a week.

Symptoms of ibuprofen overdose may include:

• dizziness
• fast eye movements that you cannot control
• slow breathing or short periods of time without breathing
• blue color around the lips, mouth, and nose

Symptoms may develop in the following areas:

Eyes, ears, nose, throat, and mouth:

• Ringing in the ears
• Blurred vision

Gastrointestinal:

• Diarrhea
• Heartburn
• Nausea, vomiting (sometimes bloody)
• Stomach pain (possible bleeding in stomach and intestines)

Heart and blood:

• Low blood pressure (shock) and weakness

Kidneys:

• Little to no urine production

Lungs:

• Breathing — difficult
• Breathing — slow
• Wheezing

Nervous system:

• Agitation, confusion, incoherent (not understandable)
• Drowsiness, even coma
• Convulsions
• Dizziness
• Headache (severe)
• Unsteadiness, trouble moving

Skin:

• Rash
• Sweating

Other:

• Chills

What to Expect at the Emergency Room

The health care provider will measure and monitor the person’s vital signs, including temperature, pulse, breathing rate, and blood pressure. Symptoms will be treated as appropriate. The person may receive:

• Activated charcoal
• Airway support, including oxygen, breathing tube through the mouth (intubation), and breathing machine (ventilator)
• Blood and urine tests
• Chest x-ray
• Tube through the mouth into the stomach and small intestine to identify and treat internal bleeding (endoscopy)
• EKG (electrocardiogram, or heart tracing)
• Fluids through a vein (intravenous or IV)
• Laxative
• Medicines to treat symptoms

Outlook (Prognosis)

Recovery is likely with prompt medical treatment, except in very large overdoses. Some people may develop chronic liver or kidney injury.

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What is naproxen

Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) medicine. Naproxen sodium works by inhibiting the enzymes Cyclooxygenase 1 (COX-1) and Cyclooxygenase 2 (COX-2) by reducing hormones prostaglandin that cause inflammation, fever and pain in the body ¹. Naproxen is used to treat inflammation and pain in joints and muscles such as arthritis, osteoarthritis, ankylosing spondylitis, rheumatoid arthritis, tendinitis, bursitis, gout, or menstrual cramps. Cyclooxygenase 1 (COX-1) is constitutively active and is expressed in most tissues, including kidney, lung, stomach, duodenum, jejunum, ileum, colon, and cecum. Cyclooxygenase 1 (COX-1) functions in gastric cytoprotection, vascular homeostasis, platelet aggregation, and maintenance of normal kidney function ². Cyclooxygenase 2 (COX-2) is an inducible enzyme expressed in the brain, kidney, and possibly in the female reproductive system ². Cyclooxygenase 2 (COX-2) expression is increased during states of inflammation ³. Cyclooxygenase 2 (COX-2) is a key source of prostacyclin (PGI₂) and is cardioprotective in ischemia–reperfusion injury ³. Naproxen analgesic activity is primarily (although not exclusively) associated with inhibition of COX-2, while different side effects result from the inhibition of COX-1 and COX-2 ⁴. Naproxen is available on prescription as tablets or as a liquid that you drink. You can buy it without a prescription from a pharmacy for period pain.

Prescription naproxen is used to:

• relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints), rheumatoid arthritis (arthritis caused by swelling of the lining of the joints), juvenile arthritis (a form of joint disease in children), and ankylosing spondylitis (arthritis that mainly affects the spine).

Prescription naproxen tablets, delayed-release or extended-release naproxen, and suspension are also used to relieve shoulder pain caused by bursitis (inflammation of a fluid-filled sac in the shoulder joint), tendinitis (inflammation of the tissue that connects muscle to bone), gouty arthritis (attacks of joint pain caused by a build-up of certain substances in the joints), and pain from other causes, including menstrual pain (pain that happens before or during a menstrual period).

Nonprescription naproxen is used to reduce fever and to relieve mild pain from headaches, muscle aches, arthritis, menstrual periods, the common cold, toothaches, and backaches.

Naproxen is NOT approved for use by anyone younger than 2 years old. Do not give naproxen to a child without medical advice. Naproxen can only be taken by children when it’s prescribed for them.

Key facts:

• Take naproxen tablets with or just after a meal or snack.
• Take the lowest dose of naproxen for the shortest time to control your symptoms.
• Naproxen may impair fertility and is not recommended in women attempting to conceive.
• The most common side effects of naproxen are confusion, headache, ringing in the ears, changes in vision, tiredness, drowsiness, dizziness and rashes.
• You should not use naproxen if you are allergic to it, or if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID.
• Taking naproxen during the last 3 months of pregnancy may harm the unborn baby. However, if it is necessary for you to take naproxen, your doctor will discuss the risks and benefits of taking this medicine during pregnancy.
• Naproxen can pass into breast milk and may cause side effects in the nursing baby. You should not breast-feed while using this medicine.
• If you take naproxen while you have an infection, naproxen may hide some of the signs of an infection (e.g. pain, fever). This may make you think, mistakenly, that you are better or that it is not serious.
• You plan to have surgery or you are being prepared for coronary bypass surgery, naproxen can prolong bleeding.
• Naproxen use in People Over 65 years: Older people may be at more risk of developing stomach ulcers and hence your doctor may prescribe a lower dose.
• Naproxen is also called by the brand names Aleve, EC-Naprosyn, Flanax Pain Reliever, Midol Extended Relief, Naprelan 375, Naprosyn, Anaprox, Anaprox-DS, Naprelan 500, Naproxen Sodium DS, Aleve Caplet, Aleve Gelcap, Aflaxen, Aleve Easy Open Arthritis, Leader Naproxen Sodium, Comfort Pac with Naproxen, Naprelan 750, Naprelan Dose Card.

Who can and can’t take naproxen

Naproxen can be taken by adults.

Naproxen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using this medicine, especially in older adults.

You should not use naproxen if you are allergic to it, or if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID.

Taking naproxen during the last 3 months of pregnancy may harm the unborn baby.

Ask a doctor or pharmacist if it is safe for you to use this medicine if you have:

• heart disease, high blood pressure, high cholesterol, diabetes, or if you smoke;
• a history of heart attack, stroke, or blood clot;
• a history of stomach ulcers or bleeding;
• asthma;
• liver or kidney disease; or
• fluid retention.

Naproxen can also be taken under medical supervision by children to treat:

• muscle and bone disorders for babies from 1 month
• diseases of the joints for children from 2 years
• period pain – for girls of any age

Naproxen isn’t suitable for certain people. Tell your doctor or pharmacist if you:

• have had an allergic reaction to naproxen or any other medicines in the past
• are allergic to aspirin or other anti-inflammatory medicines (like ibuprofen), or if you’ve developed signs of asthma (wheezing), runny nose, swelling of the skin (angioedema), or a skin rash
• have or have had stomach ulcers, bleeding in the stomach or intestines, or a hole in your stomach
• have high blood pressure
• have severe liver, kidney, or heart failure
• have Crohn’s disease or ulcerative colitis
• have lupus
• have a blood clotting disorder
• are pregnant, planning to become pregnant, or breastfeeding

Special precautions before taking naproxen

• Tell your doctor and pharmacist if you are allergic to naproxen, aspirin or other NSAIDs such as ibuprofen (Advil, Motrin) and ketoprofen, any medications for pain or fever, other medications, or any of the ingredients in naproxen products. Ask your doctor or pharmacist for a list of the ingredients.

• Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin, in Lotrel), captopril, enalapril (Vasotec, in Vaseretic), fosinopril, lisinopril (in Zestoretic), moexipril (Univasc), perindopril (Aceon, in Prestalia), quinapril (Accupril, in Quinaretic), ramipril (Altace), and trandolapril (Mavik, in Tarka); angiotensin receptor blockers (ARBs) such as azilsartan (Edarbi, in Edarbyclor), candesartan (Atacand, in Atacand HCT), eprosartan (Teveten), irbesartan (Avapro, in Avalide), losartan (Cozaar, in Hyzaar), olmesartan (Benicar, in Azor, in Benicar HCT, in Tribenzor), telmisartan (Micardis, in Micardis HCT, in Twynsta), and valsartan (in Exforge HCT); beta blockers such as atenolol (Tenormin, in Tenoretic), labetalol (Trandate), metoprolol (Lopressor, Toprol XL, in Dutoprol), nadolol (Corgard, in Corzide), and propranolol (Hemangeol, Inderal, InnoPran); cholestyramine (Prevalite); diuretics (‘water pills’); lithium (Lithobid), medications for diabetes; methotrexate (Otrexup, Rasuvo, Trexall); probenecid (Probalan; Col-Probenecid); and sulfa medications such as sulfamethoxazole (in Bactrim, in Septra). If you are taking the delayed-release tablets, also tell your doctor if you are taking antacids or sucralfate (Carafate). Your doctor may need to change the doses of your medication or monitor you more carefully for side effects.

• DO NOT take nonprescription naproxen with any other medication for pain unless your doctor tells you that you should.

• Tell your doctor if you have been told to follow a low sodium diet and if you have or have ever had any of the conditions mentioned in the IMPORTANT WARNING section or asthma, especially if you also have frequent stuffed or runny nose or nasal polyps (swelling of the inside of the nose); heart failure; swelling of the hands, arms, feet, ankles, or lower legs; anemia (red blood cells do not bring enough oxygen to all parts of the body); or liver or kidney disease.

• Tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy, you plan to become pregnant, or you are breastfeeding. If you become pregnant while taking naproxen, call your doctor.

• Talk to your doctor about the risks and benefits of taking naproxen if you are 65 years of age or older. Older adults should usually take lower doses of naproxen for short periods of time because higher doses used regularly may not be more effective and are more likely to cause serious side effects.

• If you are having surgery, including dental surgery, tell the doctor or dentist that you are taking naproxen.

• You should know that this medication may make you dizzy, drowsy, or depressed. Do not drive a car or operate machinery until you know how this drug affects you.

• Remember that alcohol can add to the drowsiness caused by this medication.

Pregnancy and breastfeeding

Naproxen isn’t normally recommended in pregnancy – especially if you’re 30 or more weeks – unless it’s prescribed by a doctor. This is because there might be a link between taking naproxen in pregnancy and some birth defects, in particular damage to the baby’s heart and blood vessels.

Tell your doctor if you’re trying to get pregnant, are already pregnant or if you’re breastfeeding.

There may also be a link between taking naproxen in early pregnancy and miscarriage.

Talk to your doctor about the benefits and possible harms of taking naproxen. It will depend on how many weeks pregnant you are and the reason you need to take the medicine. There may be other treatments that are safer for you.

Paracetamol is usually recommended as the first choice of painkiller for pregnant women.

Will naproxen affect my fertility?

Taking anti-inflammatory medicines, like naproxen, in large doses or for a long time can affect ovulation in women. This may make it more difficult to get pregnant.

Don’t take naproxen if you’re trying to get pregnant or you’re having tests for infertility. Paracetamol is a better painkiller in these situations.

Will naproxen affect my contraception?

Naproxen will not affect contraceptive pills or the morning after pill in women.

Naproxen and breastfeeding

Naproxen isn’t usually recommended during breastfeeding. Other anti-inflammatory medicines, such as ibuprofen, are safer.

However, if your baby is premature, had a low birth weight, or has an underlying medical condition, talk to your doctor before taking any painkillers.

Is naproxen an anti inflammatory?

Yes. Naproxen is a nonsteroidal anti-inflammatory drug that is used to treat inflammation and pain in joints and muscles such as arthritis, ankylosing spondylitis, tendinitis, bursitis, gout, or menstrual cramps.

Is naproxen an NSAID?

Yes. Naproxen is a NSAID (nonsteroidal anti-inflammatory drug).

What is naproxen good for?

Prescription naproxen is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints), rheumatoid arthritis (arthritis caused by swelling of the lining of the joints), juvenile arthritis (a form of joint disease in children), and ankylosing spondylitis (arthritis that mainly affects the spine). Prescription naproxen tablets, extended-release tablets, and suspension are also used to relieve shoulder pain caused by bursitis (inflammation of a fluid-filled sac in the shoulder joint), tendinitis (inflammation of the tissue that connects muscle to bone), gouty arthritis (attacks of joint pain caused by a build-up of certain substances in the joints), and pain from other causes, including menstrual pain (pain that happens before or during a menstrual period). Nonprescription naproxen is used to reduce fever and to relieve mild pain from headaches, muscle aches, arthritis, menstrual periods, the common cold, toothaches, and backaches.

When will I feel better?

You should start to feel better 1 hour after taking naproxen. However, it might take up to 3 days for naproxen to work properly if you take it regularly twice a day.

How long will I take naproxen for?

Depending on why you’re taking naproxen, you may only need to take it for a short time. For example, if you have a sore back or period pain, you may only need to take naproxen for a day or two.

You may need to take it for longer if you have a long-term condition, such as rheumatoid arthritis.

If you need to take naproxen for a long time, your doctor may prescribe a medicine to protect your stomach from side effects.

It’s best to take the lowest dose of naproxen for the shortest time to control your symptoms.

Talk to your doctor if you’re unsure how long you need to take naproxen for.

Can I take naproxen for a long time?

Naproxen can cause an ulcer in your stomach or gut if you take it for a long time or in big doses.

There’s also a small risk that people taking very big doses (at least twice the usual daily dose) for a long time may get heart failure or kidney failure.

It’s best to take the lowest dose that works for the shortest possible time.

If you need to take naproxen very often or you’re taking a big dose, talk to your doctor about your pain.

Are there other painkillers I can try?

The type of painkiller that’s best depends on what type of pain you have and the cause of your pain.

If naproxen doesn’t get rid of your pain, you can try painkillers that you can buy from shops and pharmacies, such as paracetamol or co-codamol (paracetamol combined with low-dose codeine).

If the medicine you buy isn’t controlling your pain, your doctor may recommend another type of treatment to help your pain, such as exercise or physiotherapy. Your doctor may also be able to prescribe a stronger painkiller, such as higher-dose co-codamol or codeine.

Naproxen doesn’t work for some types of pain, such as nerve pain. Your doctor will have to prescribe a different medicine if your pain is related to your nerves.

Why do I need to be careful of stomach ulcers?

Naproxen can cause an ulcer in your stomach or gut if you take it for a long time or in big doses, or if you’re elderly or in poor general health.

Your doctor may tell you not to take naproxen if you have a stomach ulcer or if you’ve had one in the past. If you need to take naproxen but you’re at risk of getting a stomach ulcer, your doctor may prescribe another medicine for you to take alongside naproxen to protect your stomach.

The most common symptom of a stomach ulcer is a burning or gnawing pain in the centre of the tummy. However, stomach ulcers aren’t always painful and some people may have other symptoms, such as indigestion, heartburn and feeling sick. If you think you may have symptoms of a stomach ulcer, stop taking naproxen and contact your doctor.

If you’re prone to stomach ulcers or have had one before, take paracetamol instead of naproxen as it’s gentler on your stomach.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

Can I drink alcohol with naproxen?

Yes, you can drink alcohol while taking naproxen. However, drinking too much alcohol may irritate your stomach and alcohol can add to the drowsiness caused by this medication.

Are there other painkillers I can try?

The type of painkiller that’s best depends on what type of pain you have and the cause of your pain.

If naproxen doesn’t get rid of your pain, you can try painkillers that you can buy from shops and pharmacies, such as paracetamol or co-codamol (paracetamol combined with low-dose codeine).

If the medicine you buy isn’t controlling your pain, your doctor may recommend another type of treatment to help your pain, such as exercise or physiotherapy. Your doctor may also be able to prescribe a stronger painkiller, such as higher-dose co-codamol or codeine.

Naproxen doesn’t work for some types of pain, such as nerve pain. Your doctor will have to prescribe a different medicine if your pain is related to your nerves.

Can naproxen cause heart failure?

It’s been said that taking anti-inflammatory medicines increases the chances of getting heart failure. However, the risk is very small for most people. The possibility of heart failure is only a problem if you have been taking very big doses (twice the usual daily dose) of naproxen for a long time.

If you find you need to take naproxen very often or you’re taking doses higher than recommended, talk to your doctor about your pain.

Some anti-inflammatory medicines are less risky than others. Your doctor will be able to help you decide which is the best one for you.

Does naproxen cause kidney failure?

Naproxen is safe for occasional use when taken as advised by a doctor. If you have problems with your kidney function, talk to your doctor about the best anti-inflammatory to take.

Nonsteroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of sudden kidney failure and even progressive kidney damage.

Does naproxen cause an irregular heartbeat?

It’s thought some anti-inflammatory medicines, including naproxen, can increase the chance of you getting an irregular heartbeat (such as atrial fibrillation or atrial flutter).

However, the chances of getting an irregular heartbeat is small and not enough to recommend people stop taking these medicines.

If you’re prescribed naproxen for a long-term condition, keep taking it and talk to your doctor if you’re worried. If you buy naproxen from a shop, occasional doses or short courses (2 or 3 days) are safe.

Does naproxen cause hearing loss?

It’s been reported that women taking some anti-inflammatory medicines, including naproxen, twice a week for more than a year have a higher chance of losing their hearing.

However, there’s no proof that naproxen and similar anti-inflammatory medicines cause hearing loss.

Hearing loss is common as people get older. There are ways to protect your hearing – for example, limiting your exposure to loud noise, wearing hearing protection in noisy places, and keeping the volume down on personal headphones.

If you find you have to take naproxen several days a week, talk to your doctor about what’s causing your pain and whether there are better ways to manage it.

Naproxen uses

Naproxen is a medicine that reduces inflammation and pain in joints and muscles. Naproxen is also used for period pain and muscle and bone disorders, such as back pain and sprains and strains.

The delayed-release or extended-release naproxen tablets are slower-acting forms of naproxen that are used only for treating chronic conditions such as arthritis or ankylosing spondylitis. These forms will not work fast enough to treat acute pain.

What is naproxen used for?

Prescription naproxen comes as a regular tablet, a delayed-release (a tablet that releases the medication in the intestine to prevent damage to the stomach) tablet, an extended-release (long-acting) tablet, and a suspension (liquid) to take by mouth. The extended-release naproxen tablets are usually taken once a day. The naproxen sodium tablets, delayed-release tablets, and suspension are usually taken twice a day for arthritis. The tablets and suspension are usually taken every 8 hours for gout, and every 6 to 8 hours as needed for pain. If you are taking naproxen on a regular basis, you should take it at the same time(s) every day.

Nonprescription naproxen comes as tablet and a gelatin coated tablet to take by mouth. It is usually taken with a full glass of water every 8 to 12 hours as needed. Nonprescription naproxen may be taken with food or milk to prevent nausea.

Follow the directions on the package or prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take naproxen exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor or written on the package.

Shake the liquid well before each use to mix the medication evenly. Use the measuring cup provided to measure each dose of the liquid.

Swallow the delayed-release tablets and extended release tablets whole; do not split, chew, or crush them.

If you are taking naproxen to relieve the symptoms of arthritis, your symptoms may begin to improve within 1 week. It may take 2 weeks or longer for you to feel the full benefit of the medication.

Stop taking nonprescription naproxen and call your doctor if your symptoms get worse, you develop new or unexpected symptoms, the part of your body that was painful becomes red or swollen, your pain lasts for more than 10 days, or your fever lasts for more than 3 days.
Other uses for this medicine

Naproxen is also sometimes used to treat Paget’s disease of bone (a condition in which the bones become abnormally thick, fragile, and misshapen) and Bartter syndrome (a condition in which the body does not absorb enough potassium, causing muscle cramping and weakness and other symptoms). Talk to your doctor about the risks of using this medication for your condition.

Naproxen sodium is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Naproxen dosage

Applies to the following strengths: 125 mg/5 mL; naproxen sodium 550 mg; naproxen sodium 275 mg; 500 mg; 375 mg; 250 mg; 375 mg (as naproxen sodium); 500 mg (as naproxen sodium); naproxen sodium 220 mg; naproxen sodium; 750 mg (as naproxen sodium); 500 mg with analgesic balm; naproxen sodium varying strength.

General:

• When treating acute painful conditions, the delayed release form is not recommended due to delay in absorption.
• Different dose strengths and dosage forms are not necessarily bioequivalent; differences should be taken into consideration when changing formulations.
• Prior to initiating treatment, the potential benefits and risks of this drug should be weighed against other treatment options.
• The lowest effective dose for the shortest duration consistent with individual patient treatment goals should be used.
• There is an increased risk of heart attack, heart failure, and stroke when taking nonsteroidal anti-inflammatory drugs (NSAIDs); these events may occur at any time during treatment and risk increases with long term use, a history of cardiovascular disease or risk factors for cardiovascular disease, and higher doses.

Monitoring:

• Cardiovascular: Monitor blood pressure closely during initiation and throughout course of therapy.
• Gastrointestinal: Monitor for signs/symptoms of gastrointestinal bleeding.
• Renal function: Monitor renal status, especially in patients with conditions where renal prostaglandins have a supportive role in the maintenance of renal perfusion.
• Monitor blood counts, renal, and hepatic function periodically for patients receiving long-term therapy.

Usual Adult Dose for Ankylosing Spondylitis

Immediate Release Tablets and Suspension:
250 mg to 500 mg (naproxen) or 275 mg to 550 mg (naproxen sodium) orally twice a day

Controlled Release:
750 mg to 1000 mg orally once a day

Delayed Release:
375 mg to 500 mg orally twice a day

Comments:

• May increase to 1500 mg orally once a day for a limited time up to 6 months in patients requiring higher levels of anti-inflammatory/analgesic activity.
• When treating patients, especially at higher doses, sufficient increased clinical benefit should be observed to offset the potential for increased risk of adverse events.
• Symptomatic improvement of arthritis is usually observed within 1 week; however, treatment for 2 weeks may be required to achieve therapeutic benefit.

Uses: For the relief of signs and symptoms of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis

Usual Adult Dose for Osteoarthritis

Immediate Release Tablets and Suspension:
250 mg to 500 mg (naproxen) or 275 mg to 550 mg (naproxen sodium) orally twice a day

Controlled Release:
750 mg to 1000 mg orally once a day

Delayed Release:
375 mg to 500 mg orally twice a day

Comments:

• May increase to 1500 mg orally once a day for a limited time up to 6 months in patients requiring higher levels of anti-inflammatory/analgesic activity.
• When treating patients, especially at higher doses, sufficient increased clinical benefit should be observed to offset the potential for increased risk of adverse events.
• Symptomatic improvement of arthritis is usually observed within 1 week; however, treatment for 2 weeks may be required to achieve therapeutic benefit.

Uses: For the relief of signs and symptoms of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis

Usual Adult Dose for Rheumatoid Arthritis

Immediate Release Tablets and Suspension:
250 mg to 500 mg (naproxen) or 275 mg to 550 mg (naproxen sodium) orally twice a day

Controlled Release:
750 mg to 1000 mg orally once a day

Delayed Release:
375 mg to 500 mg orally twice a day

Comments:

• May increase to 1500 mg orally once a day for a limited time up to 6 months in patients requiring higher levels of anti-inflammatory/analgesic activity.
  When treating patients, especially at higher doses, sufficient increased clinical benefit should be observed to offset the potential for increased risk of adverse events.
• Symptomatic improvement of arthritis is usually observed within 1 week; however, treatment for 2 weeks may be required to achieve therapeutic benefit.

Uses: For the relief of signs and symptoms of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis

Usual Adult Dose for Acute Gout

Immediate Release Tablets and Suspension:

• Initial dose: 750 mg (naproxen) or 825 mg (naproxen sodium) orally once on first day of attack
• Following initial dose: 250 mg (naproxen) or 275 mg (naproxen sodium) orally every 8 hours until attack subsides

Controlled Release:
1000 mg to 1500 mg orally once on first day of attack, followed by 1000 mg orally once a day until attack subsides

Comments:

• The delayed release tablets (EC-Naprosyn) are not recommended due to delayed absorption.

Use: For the relief of an acute gout attack

Usual Adult Dose for Bursitis

Immediate Release (naproxen sodium):
550 mg orally once, followed by 275 mg orally every 6 to 8 hours or 550 mg orally every 12 hours as needed

Maximum dose: Initial total daily dose not to exceed 1375 mg; thereafter, not to exceed 1100 mg/day

Comments:

• Naproxen (Naprosyn) may also but used, however, the delayed release tablets (EC-Naprosyn) are not recommended for initial treatment of acute pain due to delayed absorption.

Controlled Release:
1000 mg orally once a day

For patients requiring additional analgesia, may increase to 1500 mg orally once a day for a limited time; thereafter, total daily dose should not exceed 1000 mg/day

Uses: For the relief of signs and symptoms of bursitis and tendinitis

Usual Adult Dose for Tendonitis

Immediate Release (naproxen sodium):
550 mg orally once, followed by 275 mg orally every 6 to 8 hours or 550 mg orally every 12 hours as needed

Maximum dose: Initial total daily dose not to exceed 1375 mg; thereafter, not to exceed 1100 mg/day

Comments:

• Naproxen (Naprosyn) may also but used, however, the delayed release tablets (EC-Naprosyn) are not recommended for initial treatment of acute pain due to delayed absorption.

Controlled Release:
1000 mg orally once a day

For patients requiring additional analgesia, may increase to 1500 mg orally once a day for a limited time; thereafter, total daily dose should not exceed 1000 mg/day

Uses: For the relief of signs and symptoms of bursitis and tendinitis

Usual Adult Dose for Dysmenorrhea

Immediate Release (naproxen sodium):
550 mg orally once, followed by 275 mg orally every 6 to 8 hours or 550 mg orally every 12 hours as needed

Maximum dose: 1375 mg/day initial total daily dose; thereafter, not to exceed 1100 mg/day

Comments:

• Naproxen (Naprosyn) may also but used, however, the delayed release tablets (EC-Naprosyn) are not recommended for initial treatment of acute pain due to delayed absorption.

Controlled Release:
1000 mg orally once a day

For patients requiring additional analgesia, may increase to 1500 mg orally once a day for a limited time; thereafter, total daily dose should not exceed 1000 mg/day

Over the Counter:
220 mg orally every 8 to 12 hours while symptoms persist

May take 440 mg orally once in the first hour if needed

Maximum dose: 440 mg (in any 8 to 12 hour period); 660 mg (in any 24 hour period)

Uses: For the management of primary dysmenorrhea

Usual Adult Dose for Pain

Immediate Release (naproxen sodium):
550 mg orally once, followed by 275 mg orally every 6 to 8 hours or 550 mg orally every 12 hours as needed

Maximum dose: 1375 mg/day initial total daily dose; thereafter, not to exceed 1100 mg/day

Comments:

• Naproxen (Naprosyn) may also but used, however, the delayed release tablets (EC-Naprosyn) are not recommended for initial treatment of acute pain due to delayed absorption.

Controlled Release:
1000 mg orally once a day

For patients requiring additional analgesia, may increase to 1500 mg orally once a day for a limited time; thereafter, total daily dose should not exceed 1000 mg/day

Over the Counter:
220 mg orally every 8 to 12 hours while symptoms persist

May take 440 mg orally once in the first hour if needed

Maximum dose: 440 mg (in any 8 to 12 hour period); 660 mg (in any 24 hour period)

Uses: For the relief of mild to moderate pain

Usual Adult Dose for Fever

Over the Counter:
220 mg orally every 8 to 12 hours while symptoms persist

May take 440 mg orally once in the first hour if needed

Maximum dose: 440 mg (in any 8 to 12 hour period); 660 mg (in any 24 hour period)

Use: For the temporary reduction of fever

Usual Pediatric Dose for Fever

Over the Counter:
12 years or older: 220 mg orally every 8 to 12 hours while symptoms persist

May take 440 mg orally once in the first hour if needed

Maximum dose: 440 mg (in any 8 to 12 hour period); 660 mg (in any 24 hour period)

Uses: For the relief of minor aches and pains and for the temporary reduction of fever

Usual Pediatric Dose for Pain

Over the Counter:
12 years or older: 220 mg orally every 8 to 12 hours while symptoms persist

May take 440 mg orally once in the first hour if needed

Maximum dose: 440 mg (in any 8 to 12 hour period); 660 mg (in any 24 hour period)

Uses: For the relief of minor aches and pains and for the temporary reduction of fever

Usual Pediatric Dose for Juvenile Rheumatoid Arthritis

Immediate Release Tablets and Suspension:
2 years or older: 5 mg/kg orally twice a day

Comments:

• The oral suspension is recommended due to flexible dose titration based on patient’s weight.
• The delayed release formulation has not been studied in patients less than 18 years.

Use: For the relief of signs and symptoms of juvenile rheumatoid arthritis

Renal Dose Adjustments

• Mild renal dysfunction: Caution is recommended; lower doses should be considered
• Moderate to severe renal dysfunction: Not recommended.

Liver Dose Adjustments

• Dose adjustments may be required in patients with liver dysfunction, however, no specific guidelines have been suggested. Caution recommended.
• Patients who have an abnormal liver test or who develop signs or symptoms of liver dysfunction should be evaluated for hepatic dysfunction.
• If liver disease develops or if systemic manifestations such as eosinophilia or rash occur, this drug should be discontinued.

Dose Adjustments

Elderly patients may require lower doses due to increased risk for adverse effects and risk for concurrent hepatic and/or renal impairment.

How and when to take naproxen

Always take your naproxen tablets with or just after a meal so you don’t get an upset stomach. Do not take more than 3 tablets in 24 hours.

As a general rule in adults, the naproxen dose to treat:

• diseases of joints is 500mg to 1000mg a day in 1 or 2 doses
• muscle, bone disorders and painful periods is 500mg at first, then 250mg every 6 to 8 hours as required
• attacks of gout is 750mg, then 250mg every 8 hours until the attack has passed

Naproxen doses are usually lower for elderly people and people with heart, liver or kidney problems.

The doctor will use your child’s weight to work out the right naproxen dose.

If you get naproxen on prescription, the dose depends on the reason why you’re taking it, your age, how well your liver and kidneys work, and how well it helps your symptoms.

If you buy naproxen from a pharmacy for painful menstrual periods:

• on the first day – take 2 tablets when the pain starts, then after 6 to 8 hours one more tablet that day if you need to
• on the second and following days – take one tablet every 6 to 8 hours if needed

How to take naproxen

Naproxen on prescription comes as 2 different tablets – effervescent and gastro-resistant tablets.

Effervescent tablets are dissolved in water before you take them.

Gastro-resistant naproxen tablets have a coating to protect them from being broken down by the acid in your stomach. Instead, the medicine is released further down the gut in your intestine.

If you take gastro-resistant naproxen tablets, swallow them whole with or after food. Don’t crush or chew them.

If you take effervescent naproxen tablets, dissolve 1 to 2 tablets in a glass (150ml) of water and drink.

Doses of 3 tablets should be dissolved in 300ml. To make sure there is no medicine left, rinse the empty glass with a small amount of water and drink it. Take with or after food.

What if I forget to take naproxen?

Take your forgotten dose as soon as you remember, unless it’s nearly time for your next dose. Don’t take a double dose to make up for a forgotten dose.

If you forget doses often, it may help to set an alarm to remind you. You could also ask your pharmacist for advice on other ways to help you remember to take your medicine.

What if I take too much naproxen?

If you take too many naproxen tablets by accident, you’re more likely to get some of the common side effects. Contact your doctor straight away.

Naproxen side effects

Like all medicines, naproxen can cause side effects although not everyone gets them.

Common naproxen side effects

Common side effects of naproxen happen in more than 1 in 100 people and include:

• confusion
• headache
• ringing in the ears
• changes in vision
• tiredness and feeling sleepy
• dizziness
• rashes

Less common side effects of naproxen happen in more than 1 in 1,000 people. They include:

• depression
• irregular heartbeat (palpitations)
• abnormal dreams
• forgetfulness
• difficulty concentrating
• sensitivity of the skin to light (may cause blistering)
• difficulty sleeping

Rarely, naproxen can cause some side effects that happen in less than 1 in 1000 people:

• hair loss
• problems with hearing
• inflammation of blood vessels – causing fever, swelling, and generally not feeling well
• asthma getting worse
• muscle weakness and pain
• ulcers on the inner cheeks, gums and tongue

Talk to your doctor or pharmacist if these side effects bother you or don’t go away.

Serious naproxen side effects

Tell your doctor straight away if you have:

• severe indigestion, heartburn, pains in your stomach, feeling sick or vomiting or diarrhoea – these can be signs of an ulcer or inflammation in the stomach or gut
• vomiting blood or dark particles that look like coffee grounds, blood in your poo, or black, tarry-looking poo these could be signs of bleeding and perforation of the stomach or gut
• frequent sore throat, nose bleeds, and infections these can be signs of abnormalities in your blood cells, known as agranulocytosis
• fainting, chest pain, or breathlessness – these can be signs of anaemia
• fever, feeling sick or vomiting, confusion, headache, neck stiffness and sensitivity to light – these can be signs of aseptic meningitis
• a severe skin rash with flushing, blisters or ulcers – these can be signs of Stevens-Johnson syndrome)
• blood in your pee, a decrease in how much pee is passed, feeling sick or vomiting – these can be signs of kidney damage or infection
• yellowing of the skin or whites of the eyes – these can be signs of jaundice or inflammation of the liver
• irregular, slow heartbeats caused by high levels of potassium in the blood
• fever, stomach pain and vomiting – these can be signs of inflammation of the pancreas

Serious allergic reaction

In rare cases, it’s possible to have a serious allergic reaction to naproxen.

A serious allergic reaction is an emergency. Contact a doctor straight away if you think you or someone around you is having a serious allergic reaction.

The warning signs of a serious allergic reaction are:

• getting a skin rash that may include itchy, red, swollen, blistered or peeling skin
• wheezing
• tightness in the chest or throat
• having trouble breathing or talking
• swelling of the mouth, face, lips, tongue, or throat

These are not all the side effects of naproxen. For a full list see the leaflet inside your medicines packet.

How to cope with naproxen side effects

What to do about:

• headache – make sure you rest and drink plenty of fluids. Don’t drink too much alcohol. Ask your pharmacist to recommend a painkiller. Headaches should usually go away after the first week of taking naproxen. Talk to your doctor if they last longer than a week or are severe.
• feeling sleepy, tired or dizzy – as your body gets used to naproxen, these side effects should wear off.
• changes in vision – don’t drive for a week.
• dizziness – if naproxen makes you feel dizzy, stop what you’re doing and sit or lie down until you feel better.

Human Toxicity Reports

Most cases of naproxen overdosage have been reported in adults ⁵. Adverse gastrointestinal effects (e.g., heartburn, vomiting) and seizures usually occur in these patients; drowsiness and prolongation of clotting time also may occur. The incidence of adverse effects in adults may differ from those in children since rash and prolonged bleeding time appear to occur more frequently in children while other reactions occur more frequently in adults; the incidence of adverse gastrointestinal and CNS (central nervous system) effects are similar ⁵. Toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome, urticaria, alopecia, erythema nodosum, fixed drug eruption, lichen planus, and pustular reaction have been reported during postmarketing experience ⁶.

Pseudoporphyria, a cutaneous disorder characterized by skin fragility, vesiculation, and scarring, has been reported as a side effect of naproxen therapy in children with juvenile rheumatoid arthritis ⁷. The results of a 6-month prospective study to determine the prevalence of pseudoporphyria in the juvenile rheumatoid arthritis population are presented. All the patients with pseudoporphyria had received naproxen for > or = 4 weeks at the time of the study. Of the patients treated with naproxen, 12% (9/74) developed this complication ⁷. No patient had significant elevation of free erythrocyte protoporphyrin, excluding the diagnosis of true erythropoietic protoporphyria. The study authors conclude that pseudoporphyria is a common side effect of naproxen therapy in children with juvenile rheumatoid arthritis, even in geographic areas without high sun exposure ⁷. Because of the risk of facial scarring with pseudoporphyria, physicians and parents of children with juvenile rheumatoid arthritis should be aware of this complication.

Severe, sometimes fatal, toxicity has occurred following administration of a nonsteroidal anti-inflammatory drug (NSAID) concomitantly with methotrexate (principally high-dose therapy) in patients with various malignant neoplasms or rheumatoid arthritis ⁸. The toxicity was associated with elevated and prolonged blood concentration of methotrexate. The exact mechanism of the interaction remains to be established, but it has been suggested that nonsteroidal anti-inflammatory drugs (NSAIDs) may inhibit renal elimination of methotrexate, possibly by decreasing renal perfusion via inhibition of renal prostaglandin synthesis or by competing for renal elimination ⁸. Naproxen and methotrexate should be administered concomitantly with caution. Pending further accumulation of data, some clinicians recommend that nonsteroidal anti-inflammatory drugs be avoided in patients receiving methotrexate ⁸.

Jaundice (including cholestatic jaundice which cleared promptly when naproxen was discontinued) and fatal hepatitis have been reported rarely in patients receiving naproxen ⁶. Abnormal liver function test results, including mild and generally transient increases in serum alkaline phosphatase, have occurred in some patients.

A case report of a pre-term infant who developed severe hyponatremia and water retention associated with the ingestion of an overdose of the non-steroid anti-inflammatory drug naproxen eight hours before delivery is reported ⁹. Recovery was complete and subsequent development unimpaired.

The development of acute renal failure and interstitial nephritis due to therapeutic doses of non-steroidal anti-inflammatory drugs (NSAIDs) has been documented repeatedly in adult patients but is rare in children ¹⁰. This study report the occurrence of this complication in a child. Acute renal failure and hyperkalemia developed in a 2-year-old boy with juvenile rheumatoid arthritis after one month of naproxen sodium therapy ¹⁰. The evidence of renal toxic effects became manifest after an episode of dehydration. A percutaneous renal biopsy specimen revealed interstitial nephritis. The patient recovered promptly after withdrawal of the drug ¹⁰.

The occurrence of severe acute renal failure in a 10-year-old girl with juvenile rheumatoid arthritis after 1 month of naproxen therapy is reported ¹¹. Renal biopsy showed severe acute interstitial nephritis. The patient recovered completely after discontinuation of naproxen and administration of methylprednisolone ¹¹.

Renal failure occurred in a 14-year-old girl with peripheral arthritis associated with inflammatory bowel disease while she was being treated with naproxen ¹². She had previously received aspirin and tolmetin sodium and had no complications. A renal biopsy showed a severe tubulointerstitial nephritis. Although her renal function improved somewhat with corticosteroid treatment, it worsened when the steroids were discontinued ¹².

A case of a 3,790-g term neonate who developed persistent pulmonary hypertension after birth with a closed ductus arteriosus is reported ¹³. The mother admitted to taking naproxen sodium immediately prior to the birth of the infant. The course of illness was progressively better on conservative management. Like indomethacin, other nonsteroid anti-inflammatory drugs (NSAIDs) can also cause premature closure of fetal ductus arteriosus, pulmonary hypertension, and life-threatening problems to the neonate ¹³.

Pulmonary infiltrates developed in three middle-aged women while receiving naproxen sodium ¹⁴. Weakness, fatigue, cough, low-grade fever, and eosinophilia in blood and/or sputum were common to all. All symptoms and findings resolved within a few days after discontinuing naproxen therapy in two cases and with use of corticosteroids (prednisone) in one case. A hypersensitivity reaction due to naproxen seemed to be the likely cause ¹⁴.

A 12 year old boy developed scars at light-exposed areas following long-term therapy with naproxen for rheumatoid arthritis ¹⁵. Erythrocyte and urine porphyrin levels were not increased, and there was no evidence of increased photosensitivity. Pseudoporphyria is reported in 10-20% of those treated with naproxen for > 4 weeks ¹⁵. As compared to other nonsteroidal anti-inflammatory agents, the specific risk for naproxen is increased about 6 fold ¹⁵. While the underlying abnormality has not been elucidated, formation of phototoxic metabolites in a subgroup of genetically predisposed individuals has been suggested as the most likely mechanism. Both dermatologists and rheumatologists should be aware of the risk of naproxen-induced pseudoporphyria and discontinue therapy early in order to avoid scar formation in light-exposed areas.

Transient prolongation of the prothrombin time (bleeding time) was observed in the setting of a 10 g overdose of naproxen ¹⁶. The patient reported was previously healthy, without chronic liver disease, bleeding disorders, or malnutrition. The most likely mechanism for this effect is direct inhibition of the synthesis of vitamin-K-dependent clotting factors, possibly via production of “abnormal” prothrombin.

A case report of a 39 yr old man who developed dyspnea and periorbital edema following a dosage increase in naproxen after he was previously stabilized on the drug for approximately 1 yr is reported ¹⁷. The patient had been taking oral naproxen 375 mg 3 times daily for back pain. He reported mild shortness of breath and hoarseness after taking the first dose of naproxen, but the reaction subsided and he continued treatment without further adverse effects. After approximately 1 yr, the patient began experiencing increased back pain and his physician increased the naproxen dosage to 500 mg 3 times daily. Within an hr of ingesting the 500 mg dose, the patient developed dyspnea, shortness of breath, hoarseness, and difficulty swallowing. Upon arrival at the emergency room, he was noted to have bilateral periorbital edema. He was treated with subcutaneous epinephrine, parenteral methylprednisolone, and oral diphenhydramine with adequate response. Naproxen therapy was discontinued and the patient was discharged the following day ¹⁷.

Naproxen emergency/overdose

In case of overdose, call the Poison Help hotline at 1-800-222-1222 from anywhere in the United States. This hotline number will let you talk to experts in poisoning. They will give you further instructions. This is a free and confidential service. You should call if you have any questions about poisoning or poison prevention. You can call 24 hours a day, 7 days a week.

Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call your local emergency services number.

Symptoms of overdose may include the following:

• Dizziness, unsteadiness, movement problems
• Extreme tiredness
• Drowsiness
• Stomach pain (possible bleeding in the stomach and intestines)
• Heartburn
• Nausea
• Vomiting
• Slow labored breathing, wheezing or difficult breathing
• Agitation, confusion, incoherence (the person is not understandable)
• Blurred vision
• Coma
• Convulsions (seizures)
• Diarrhea
• Headache — severe
• Rash
• Ringing in the ears

What to Expect at the Emergency Room

The health care provider will measure and monitor the person’s vital signs, including temperature, pulse, breathing rate, and blood pressure. Symptoms will be treated as appropriate. The person may receive:

• Activated charcoal
• Blood and urine tests
• Fluids through a vein (IV)
• Laxatives
• Medicines to treat symptoms

In rare, serious cases, more treatments may be needed. Most people will be discharged from the emergency department after being observed for a period of time.

Outlook (Prognosis)

Recovery is likely.

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What is Advil-Migraine

Advil-Migraine is a medicine that contains a nonsteroidal anti-inflammatory drug (NSAID) – Ibuprofen and is available over-the-counter to relieve pain, treats migraine and reduce fever. Advil-Migraine (ibuprofen) is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild to moderate pain, fever and pain caused by inflammation. Advil-Migraine (ibuprofen) also helps to relieve symptoms of arthritis (osteoarthritis, rheumatoid arthritis, or juvenile arthritis), such as inflammation, swelling, stiffness, and joint pain. Advil-Migraine does not cure arthritis and will help you only as long as you continue to take it. In addition, Advil-Migraine (ibuprofen) can be used to treat fever, menstrual cramps, and other conditions as determined by your doctor.

You can buy most types of Advil-Migraine (ibuprofen) from pharmacies and supermarkets. Some types are only available on prescription.

Advil-Migraine (ibuprofen) works by inhibiting the enzymes Cyclooxygenase 1 (COX-1) and Cyclooxygenase 2 (COX-2) by reducing hormones prostaglandin that cause inflammation, fever and pain in your body ¹. Advil-Migraine (ibuprofen) reduces the ability of your body to make prostaglandins – chemicals that promote pain, inflammation and fever. With fewer prostaglandins in your body, fever eases off, and pain and inflammation is reduced. Cyclooxygenase 1 (COX-1) is constitutively active and is expressed in most tissues, including kidney, lung, stomach, duodenum, jejunum, ileum, colon, and cecum. Cyclooxygenase 1 (COX-1) functions in gastric cytoprotection, vascular homeostasis, platelet aggregation, and maintenance of normal kidney function ². Cyclooxygenase 2 (COX-2) is an inducible enzyme expressed in the brain, kidney, and possibly in the female reproductive system ². Cyclooxygenase 2 (COX-2) expression is increased during states of inflammation ³. Cyclooxygenase 2 (COX-2) is a key source of prostacyclin (PGI2) and is cardioprotective in ischemia–reperfusion injury ³. Advil-Migraine (ibuprofen) analgesic activity is primarily (although not exclusively) associated with inhibition of COX-2, while different side effects result from the inhibition of COX-1 and COX-2 ⁴.

Key facts

• Advil-Migraine (ibuprofen) takes 20 to 30 minutes to work if you take it by mouth.
• Advil-Migraine (ibuprofen) works by reducing hormones that cause pain and swelling in the body.
• Taking any form of painkiller frequently can make migraines worse. This is sometimes called “medication overuse headache” or “painkiller headache”.
• Speak to your doctor if you find yourself needing to use painkillers repeatedly or if over-the-counter painkillers aren’t effective. Your doctor may prescribe stronger painkillers or recommend using painkillers along with triptans (see below). If they suspect the frequent use of painkillers may be contributing your headaches, they may recommended that you stop using them.
• Always take Advil-Migraine (ibuprofen) tablets and capsules with food or a drink of milk to reduce the chance of an upset tummy. Don’t take it on an empty stomach.
• If you’re taking tablets, take the lowest dose for the shortest time. Don’t use it for a long time unless you’ve talked about it with your doctor.
• If the treatments above aren’t effectively controlling your migraines, your doctor may refer you to a specialist migraine clinic for further investigation and treatment. A specialist may recommend other treatments such as transcranial magnetic stimulation.
• Transcranial magnetic stimulation involves holding a small electrical device to your head that delivers magnetic pulses through your skin. It’s not clear exactly how transcranial magnetic stimulation works in treating migraines, but studies have shown that using it at the start of a migraine can reduce its severity. It can also be used in combination with the medications mentioned above without interfering with them. However, transcranial magnetic stimulation isn’t a cure for migraines and it doesn’t work for everyone. The evidence for its effectiveness isn’t strong and is limited to people who have migraine with aura. There’s also little evidence about the potential long-term effects of the treatment, although studies into the treatment have so far only reported minor and temporary side effects, including:
  • slight dizziness
  • drowsiness and tiredness
  • a muscle tremor that can make it difficult to stand
  • irritability

How long does it take for Advil-Migraine to work?

You should start to feel better 20 to 30 minutes after taking Advil-Migraine (ibuprofen) by mouth.

Advil-Migraine vs Advil

Advil-Migraine contains the same amount of the active ingredient 200 mg ibuprofen as the standard Advil, except Advil-Migraine has the solubilized version of the ibuprofen, which may have a quicker onset.

Can you take Excedrin-Migraine with Advil?

No, because Excedrin-Migraine contains aspirin which belongs to the same group of medicine as Advil (ibuprofen) called non-steroidal anti-inflammatory drugs (NSAIDs). If you take them together, Advil-Migraine (ibuprofen) plus aspirin (Excedrin-Migraine) may increase the chance of you getting side effects like stomach ache.

Taking Advil-Migraine with other painkillers

It’s safe to take Advil-Migraine (ibuprofen) with acetaminophen or codeine.

But don’t take Advil-Migraine (ibuprofen) with similar painkillers like aspirin or naproxen (Aleve) without talking to a doctor.

Advil-Migraine (ibuprofen), aspirin and naproxen belong to the same group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). If you take them together, Advil-Migraine (ibuprofen) plus aspirin or naproxen may increase the chance of you getting side effects like stomach ache.

Alternatives to Advil-Migraine

For treating fever, an alternative to Advil-Migraine (ibuprofen) is acetaminophen (Tylenol).

For pain or inflammation-related swelling, ask your doctor or pharmacist for an alternative if Advil-Migraine (ibuprofen) is not suitable for you. Your health professional may suggest you try:

• acetaminophen (paracetamol)
• another medicine from the NSAID family
• a medicine that combines codeine with acetaminophen in the same tablet.

If your pain is severe, your doctor may prescribe you a stronger pain reliever.

Treating migraine without medicine

The following non-medicine treatments may help you to prevent frequent or troublesome migraines — you can use them either instead of, or as well as, medicine treatments:

• physical therapies (eg, physiotherapy or chiropractic treatment), especially if neck problems are thought to be contributing to your migraines — it’s essential to seek out a therapist with specialist training in this area, however, as there have been very rare reports of stroke after spinal manipulation of the neck
• physical exercise
• relaxation training (eg, yoga, meditation), which can help manage underlying problems with stress
• cognitive behavioral therapy (CBT), a psychological therapy that teaches you to identify and challenge stress generating thoughts
• acupuncture. If medication is unsuitable, or it doesn’t help to prevent migraines, you may want to consider acupuncture.

Medicines for an acute migraine attack

There’s currently no cure for migraines, although a number of treatments are available to help ease the symptoms.

Most people find that sleeping or lying in a darkened room is the best thing to do when having a migraine attack.

Others find that eating something helps, or they start to feel better once they’ve been sick.

It may take time to work out the best treatment for you. You may need to try different types or combinations of medicines before you find the most effective ones.

Doctors recommend a stepped approach to treatment for acute migraine attack; that is, trying the simplest remedy first. If this fails to manage your pain — as a general rule on 3 consecutive occasions — then you should try the next treatment.

• Step 1. Simple pain relief medicine alone

Most simple pain relief medicines are available to buy over-the-counter in pharmacies and supermarkets.

Many people who have migraines find that over-the-counter painkillers, such as acetaminophen (Tylenol), aspirin and ibuprofen (Advil, Advil-Migraine or Motrin IB), can help to reduce their symptoms.

They tend to be most effective if taken at the first signs of a migraine attack, as this gives them time to absorb into your bloodstream and ease your symptoms.

It’s not advisable to wait until the headache worsens before taking painkillers as it’s often too late for the medication to work. Soluble painkillers (tablets you dissolve in a glass of water) like Advil-Migraine are a good alternative because they’re absorbed quickly by your body.

If you can’t swallow painkillers because of nausea or vomiting, suppositories may be a better option. These are capsules that are inserted into the anus (back passage).

Take pain relief medicine at the first sign of migraine symptoms. As a migraine progresses, your stomach emptying can slow and this can affect the absorption of pain relievers into your bloodstream, making them less effective. This is especially important if you experience nausea and vomiting with migraine.

• Step 2. Simple pain reliever and medicine for nausea and vomiting

If nausea is a problem, or if a pain reliever alone does not relieve your migraine pain, you can take the pain reliever with medicine to treat nausea and vomiting.

Medication for nausea is usually combined with other medications. Frequently prescribed medications are chlorpromazine, metoclopramide (Reglan) or prochlorperazine (Compro).

• Step 3. Anti-migraine medicine: the triptans

If you find you can’t manage your migraines using over-the-counter medicines, your doctor may prescribe something stronger.

Triptans work differently to pain relievers. Triptan medicines are a specific painkiller for migraine headaches. There are a number of different triptans available in the US and you will need to get a prescription from your doctor.

Triptans are thought to work by reversing the changes in the brain that may cause migraine headaches.

They cause the blood vessels around the brain to contract (narrow). This reverses the dilating (widening) of blood vessels that’s believed to be part of the migraine process.

Triptans are available as tablets, injections and nasal sprays.

Common side effects of triptans include:

• warm-sensations
• tightness
• tingling
• flushing
• feelings of heaviness in the face, limbs or chest

Some people also experience nausea, dry mouth and drowsiness. These side effects are usually mild and improve on their own.

As with other painkillers, taking too many triptans can lead to medication overuse headache.

Your doctor will usually recommend having a follow-up appointment once you’ve finished your first course of treatment with triptans. This is so you can discuss their effectiveness and whether you had any side effects.

If the medication was helpful, treatment will usually be continued. If they weren’t effective or caused unpleasant side effects, your doctor may try prescribing a different type of triptan since responses can be highly variable.

• Step 4. Preventive therapy

If you are experiencing two or more severe migraine attacks a month, you could be a candidate for preventive therapy. Preventive therapy is used in addition to treatments for acute attack, not in place of it.

The aim of migraine preventive therapy is to reduce the number of attacks to a manageable level, either because:

• the medicines used to treat attacks don’t control your symptoms adequately, or
• migraine attacks, even though well controlled, are happening far too often, placing you at risk of developing medication overuse headache.

Note that it may take some months for the full effect of preventive therapy to be seen.

In general, medicines used as preventive therapy are more commonly prescribed for the treatment of other conditions (eg, high blood pressure or depression) but have unrelated anti-migraine effects — for example:

• beta-blockers — Propranolol (Deralin), atenolol (Noten, Anselol), metoprolol (Betaloc, Lopressor)
• amitriptyline (Endep).

Other medicines occasionally used to prevent migraines include antiepileptic medicines (especially sodium valproate [Epilim, Valpro] and topiramate [Epiramax, Tamate]), methysergide (Deseril) and botulinum toxin (botox).

Treatment can be complicated and is best managed by a specialist (neurologist).

Is Advil-Migraine better than acetaminophen or aspirin?

Advil-Migraine (ibuprofen), acetaminophen (paracetamol) and aspirin are all effective painkillers.

Advil-Migraine (ibuprofen) is good for period pain and migraines. It can also be used for back pain, strains and sprains, as well as pain from arthritis.

Acetaminophen (Tylenol) is typically used for mild or moderate pain. Acetaminophen (Tylenol, others), also may help relieve mild migraines in some people. It may be better than Advil-Migraine (ibuprofen) for headaches, toothache, sprains, stomach ache, and nerve pain like sciatica.

Aspirin works in a similar way to Advil-Migraine (ibuprofen). Like Advil-Migraine (ibuprofen), it’s good for period pain and migraines. (If you have heavy periods, it can make them heavier.)

How long will I take Advil-Migraine tablets for?

If you’re taking Advil-Migraine (ibuprofen) for a short-lived pain like migraine, you may only need to take it for a day or two.

If you need to take Advil-Migraine (ibuprofen) for more than 6 months, your doctor may prescribe a medicine to protect your stomach from any side effects.

Can I take Advil-Migraine for a long time?

It’s safe to take Advil-Migraine (ibuprofen) regularly for many years if you need to as long as you don’t take more than the recommended dosage.

If you need to take Advil-Migraine (ibuprofen) by mouth for a long time and you’re at risk of getting a stomach ulcer, your doctor may prescribe a medicine to help protect your stomach.

Does Advil-Migraine cause stomach ulcers?

Advil-Migraine (ibuprofen) can cause ulcers in your stomach or gut, especially if you take it by mouth for a long time or in big doses.

If you need to take Advil-Migraine (ibuprofen) and you’re at risk of getting a stomach ulcer, your doctor may prescribe a medicine to help protect your stomach.

Can I drink alcohol with Advil-Migraine?

It’s usually safe to drink alcohol while taking Advil-Migraine (ibuprofen). But if you’re taking Advil-Migraine (ibuprofen) by mouth, drinking too much alcohol may irritate your stomach and increases your risk of getting stomach ulcers.

Is there any food or drink I need to avoid?

You can eat and drink normally while taking any type of Advil-Migraine (ibuprofen).

It’s best to take Advil-Migraine (ibuprofen) tablets, capsules or syrup with, or just after, a meal so it doesn’t upset your stomach. Don’t take it on an empty stomach.

What if Advil-Migraine doesn’t work?

If Advil-Migraine (ibuprofen) doesn’t work, there are other everyday painkillers you can try, such as:

• acetaminophen (paracetamol)
• aspirin
• co-codamol (acetaminophen combined with low-dose codeine). Opioid medications containing narcotics, particularly codeine, are sometimes used to treat migraine pain for people who can’t take triptans or ergots. Narcotics are habit-forming and are usually used only if no other treatments provide relief.

If pharmacy painkillers don’t work, your doctor may be able to prescribe a stronger painkiller or recommend another treatment, such as triptans or ergots.

Ergotamine and caffeine combination drugs (Migergot, Cafergot) are less effective than triptans. Ergots seem most effective in those whose pain lasts for more than 48 hours. Ergots are most effective when taken soon after migraine symptoms start.

Ergotamine may worsen nausea and vomiting related to your migraines, and it may also lead to medication-overuse headaches.

Dihydroergotamine (D.H.E. 45, Migranal) is an ergot derivative that is more effective and has fewer side effects than ergotamine. It’s also less likely to lead to medication-overuse headaches. It’s available as a nasal spray and in injection form.

Will Advil-Migraine affect my fertility?

Taking Advil-Migraine (ibuprofen) by mouth, in large doses, or for a long time can affect ovulation in women, possibly making it more difficult for you to get pregnant. This is usually reversible when you stop taking Advil-Migraine (ibuprofen).

Don’t take Advil-Migraine (ibuprofen) tablets, capsules or syrup if you’re trying for a baby. Acetaminophen (Paracetamol) is a better option.

Will Advil-Migraine affect my contraception?

Advil-Migraine (ibuprofen) – by mouth or on your skin – doesn’t affect any contraceptives, including the contraceptive pill and the morning after pill.

Advil-Migraine vs Excedrin Migraine

Advil-Migraine contains 200 mg ibuprofen a nonsteroidal anti-inflammatory drug (NSAID).

Excedrin-Migraine is a medicine that contains active ingredients in a combination of Acetaminophen (paracetamol), Aspirin, and Caffeine. Acetaminophen is a pain reliever and a fever reducer. Aspirin is acetylsalicylic acid in a group of drugs called salicylates, classified as a non-steroidal anti-inflammatory drug (NSAID). Aspirin works by reducing substances in your body that cause pain, fever, and inflammation. Caffeine is a central nervous system stimulant. Caffeine relaxes muscle contractions in blood vessels to improve blood flow.

Excedrin Migraine may also ease moderate migraine pain. But they aren’t effective alone for severe migraines. If taken too often or for long periods of time, these medications can lead to ulcers, gastrointestinal bleeding and medication-overuse headaches.

Pregnancy and breastfeeding

Advil-Migraine (ibuprofen) isn’t normally recommended in pregnancy.

It may cause birth defects affecting the baby’s heart or blood vessels. There may also be a link between taking Advil-Migraine (ibuprofen) in early pregnancy and miscarriage.

Acetaminophen (paracetamol) is the best painkiller to take during pregnancy.

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

This medicine may be harmful to an unborn baby. Taking ibuprofen during the last 3 months of pregnancy may result in birth defects and prolonged labor and delivery. Do not use this medicine without a doctor’s advice if you are pregnant.

Use in late pregnancy should be avoided. May constrict ductus arteriosus in utero or inhibit or prolong labor as result of inhibition of prostaglandin synthetase ⁵.

For safety, tell your pharmacist or doctor if you’re trying to get pregnant, are already pregnant or if you’re breastfeeding.

To assess the fetal effects of exposure to ibuprofen overdose in pregnancy ⁶. Ibuprofen, a non-steroidal anti-inflammatory drug (NSAID) is a frequently used analgesic that is readily available over the counter. Concerns have been raised that therapeutic use of NSAIDs is associated with an increased risk of miscarriage and renal dysfunction. Although most acute overdoses are of low toxicity, few data exist on the potential fetotoxicity of ibuprofen overdose during pregnancy. Using standardized procedures, National Technical Information Service (NTIS) has provided fetal risk assessment and collected outcome data on a prospective case series of 100 women who took ibuprofen in overdose during pregnancy. Results are the majority of liveborn infants (66/73=90.4%) had no congenital anomalies. No pattern of anomalies was observed. Multidrug overdoses in which ibuprofen was the major constituent were taken by 68%, mainly compound analgesics and cold remedies with 28% taking paracetamol. The majority (86%) of overdoses occurred in the first trimester with only 9 (9%) reports of any significant maternal toxicity including 1 mother who was unconscious. Conclusion: The incidence of miscarriages (9% versus 10-20%) and terminations (18% versus 23%) is within the expected range ⁶. However, the incidence of congenital anomalies is higher (7/73=9.6% versus 2-3% expected), but two exposures were second trimester, and the numbers are small. Although no pattern of malformations was seen, three were cardiac anomalies ⁶. As congenital heart anomalies are common 0.5-1% it is not possible to establish a causal relationship with the drugs taken in overdose. No cases of renal dysfunction were seen. In the majority of women who receive appropriate treatment at the time of the overdose the outcome of pregnancy is a normal baby ⁶.

Advil-Migraine (ibuprofen) and breastfeeding

Advil-Migraine (ibuprofen) is safe to take by mouth if you are breastfeeding.

Two early studies attempted measurement of ibuprofen in milk ⁷, ⁸. In one, the patient’s dose was 400 mg twice daily, while in the second study of 12 patients, the dose was 400 mg every 6 hours. Ibuprofen was undetectable in breastmilk in both studies (<0.5 and 1 mg/L, respectively) ⁷, ⁸.

A later study using a more sensitive assay found ibuprofen in the breastmilk of one woman who took 6 doses of 400 mg orally over a 42.5 hours. A milk ibuprofen level of 13 mcg/L was detected 30 minutes after the first dose. The highest level measured was 180 mcg/L about 4 hours after the third dose, 20.5 hours after the first dose. The authors estimated that the infant would receive about 17 mcg/kg daily (100 mcg daily) with the maternal dose of approximately 1.2 grams daily. This dose represents 0.0008% of the maternal weight-adjusted dosage ⁹ and 0.06% of the commonly accepted infant dose of 30 mg/kg daily (10 mg/kg every 8 hours).

Single milk samples were taken from 13 women between 1.5 and 8 hours after the third dose of ibuprofen in a daily dosage regimen averaging 1012 mg daily (range 400 to 1200 mg daily). Of the 13 milk samples analyzed, the mean milk concentration was 361 mcg/L (range 164 to 590 mcg/L). The mean weight-adjusted percentage of the maternal dosage (relative infant dosage) was estimated to be <0.38%; however, the relative infant dosage varied with the time postpartum and the milk protein content. The relative infant dosage was highest in the colostral phase when the milk protein content was the highest (relative infant dosage 0.6%). The estimated mean dosage for a fully breastfed infants was 68 mcg/kg daily or 0.2% of a pediatric dosage ¹⁰.

What is Advil-Migraine (ibuprofen) used for?

Advil-Migraine (ibuprofen) can be used for the short-term relief of fever, mild to moderate pain and inflammation (redness, swelling and soreness).

Advil-Migraine (ibuprofen) might ease some of the symptoms of:

• headaches e.g. migraines or tension headache
• sinus pain
• toothache and pain after dental procedures
• backache, muscular aches and pains
• period pain/primary dysmenorrhea
• sore throat
• joint or tendon sprains and strains such as tennis elbow
• arthritis
• fever (pyrexia) or high temperature.
• Advil-Migraine (ibuprofen) is also indicated for the relief of acute and/or chronic pain states in which there is an inflammatory component. For example, Rheumatoid arthritis, Juvenile rheumatoid arthritis and Osteoarthritis

Please note that Advil-Migraine (ibuprofen) provides only temporary relief – it won’t cure your condition.

Advil-Migraine vs Ibuprofen

Advil-Migraine is a medicine that contains a nonsteroidal anti-inflammatory drug (NSAID) – Ibuprofen.

Who can and can’t take Advil-Migraine

Some brands of Advil-Migraine (ibuprofen) tablets, capsules and syrup contain aspartame, colors (E numbers), gelatin, glucose, lactose, sodium, sorbitol, soya or sucrose, so they may be unsuitable for some people.

Don’t take Advil-Migraine (ibuprofen) by mouth if you:

• have had an allergic reaction to Advil-Migraine (ibuprofen) or any other medicines in the past
• have previously had a reaction, such as asthma, a raised, itchy red rash (urticaria), swelling underneath your skin (angioedema) or swelling of the inside of your nose (rhinitis)
• have taken aspirin or any other nonsteroidal anti-inflammatory drug (NSAID)
• have asthma or another allergic illness
• are trying to get pregnant, are already pregnant or if you’re breastfeeding

To make sure Advil-Migraine (ibuprofen) (by mouth) is safe for you, tell your doctor or pharmacist if you have:

• had bleeding in your stomach, a stomach ulcer, or a perforation (a hole) in your stomach
• a health problem that means you have an increased chance of bleeding
• liver problems, such as liver fibrosis, cirrhosis or liver failure
• heart disease or severe heart failure
• kidney failure
• Crohn’s disease or ulcerative colitis
• chickenpox or shingles – taking Advil-Migraine (ibuprofen) can increase the chance of certain infections and skin reactions

Cautions with other medicines

Advil-Migraine (ibuprofen) doesn’t mix well with some medicines.

Advil-Migraine (ibuprofen) applied to the skin is less likely to interfere with other medicines than if it’s taken by mouth.

For safety, tell your doctor if you’re taking these medicines before you start taking Advil-Migraine (ibuprofen) by mouth or on your skin:

• blood-thinning medicines such as warfarin
• anti-inflammatory painkillers such as aspirin, diclofenac, mefenamic acid and naproxen
• medicines for high blood pressure
• steroid medicines such as betamethasone, dexamethasone, hydrocortisone or prednisolone
• antibiotics such as ciprofloxacin, levofloxacin, moxifloxacin, nalidixic acid, norfloxacin or ofloxacin
• antidepressants such as citalopram, fluoxetine, fluvoxamine, venlafaxine, paroxetine or sertraline
• diabetes medicines such as gliclazide, glimepiride, glipizide and tolbutamide

Other uses for Advil-Migraine

Advil-Migraine (ibuprofen) is also sometimes used to treat ankylosing spondylitis (arthritis that mainly affects the spine), gouty arthritis (joint pain caused by a build-up of certain substances in the joints), and psoriatic arthritis (arthritis that occurs with a long-lasting skin disease that causes scaling and swelling). Talk to your doctor about the risks of using this drug for your condition.

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Prescription Advil-Migraine (ibuprofen) comes as a tablet to take by mouth. It is usually taken three or four times a day for arthritis or every 4 to 6 hours as needed for pain. Nonprescription Advil-Migraine (ibuprofen) comes as a tablet, chewable tablet, suspension (liquid), and drops (concentrated liquid). Adults and children older than 12 years of age may usually take nonprescription Advil-Migraine (ibuprofen) every 4 to 6 hours as needed for pain or fever. Children and infants may usually be given nonprescription Advil-Migraine (ibuprofen) every 6 to 8 hours as needed for pain or fever, but should not be given more than 4 doses in 24 hours. Advil-Migraine (ibuprofen) may be taken with food or milk to prevent stomach upset. If you are taking Advil-Migraine (ibuprofen) on a regular basis, you should take it at the same time(s) every day. Follow the directions on the package or prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take Advil-Migraine (ibuprofen) exactly as directed. Do not take more or less of it or take it more often than directed by the package label or prescribed by your doctor.

Advil-Migraine (ibuprofen) comes alone and in combination with other medications. Some of these combination products are available by prescription only, and some of these combination products are available without a prescription and are used to treat cough and cold symptoms and other conditions. If your doctor has prescribed a medication that contains Advil-Migraine (ibuprofen), you should be careful not to take any nonprescription medications that also contain Advil-Migraine (ibuprofen).

If you are selecting a product to treat cough or cold symptoms, ask your doctor or pharmacist for advice on which product is best for you. Check nonprescription product labels carefully before using two or more products at the same time. These products may contain the same active ingredient(s) and taking them together could cause you to receive an overdose. This is especially important if you will be giving cough and cold medications to a child.

Nonprescription cough and cold combination products, including products that contain Advil-Migraine (ibuprofen), can cause serious side effects or death in young children. Do not give these products to children younger than 4 years of age. If you give these products to children 4 to 11 years of age, use caution and follow the package directions carefully.

If you are giving Advil-Migraine (ibuprofen) or a combination product that contains Advil-Migraine (ibuprofen) to a child, read the package label carefully to be sure that it is the right product for a child of that age. Do not give Advil-Migraine (ibuprofen) products that are made for adults to children.

Before you give an Advil-Migraine (ibuprofen) product to a child, check the package label to find out how much medication the child should receive. Give the dose that matches the child’s age on the chart. Ask the child’s doctor if you don’t know how much medication to give the child.

Shake the suspension and drops well before each use to mix the medication evenly. Use the measuring cup provided to measure each dose of the suspension, and use the dosing device provided to measure each dose of the drops.

The chewable tablets may cause a burning feeling in the mouth or throat. Take the chewable tablets with food or water.

Stop taking nonprescription Advil-Migraine (ibuprofen) and call your doctor if your symptoms get worse, you develop new or unexpected symptoms, the part of your body that was painful becomes red or swollen, your pain lasts for more than 10 days, or your fever lasts more than 3 days. Stop giving nonprescription Advil-Migraine (ibuprofen) to your child and call your child’s doctor if your child does not start to feel better during the first 24 hours of treatment. Also stop giving nonprescription Advil-Migraine (ibuprofen) to your child and call your child’s doctor if your child develops new symptoms, including redness or swelling on the painful part of his body, or if your child’s pain or fever get worse or lasts longer than 3 days.

Do not give nonprescription Advil-Migraine (ibuprofen) to a child who has a sore throat that is severe or does not go away, or that comes along with fever, headache, nausea, or vomiting. Call the child’s doctor right away, because these symptoms may be signs of a more serious condition.

Before taking Advil-Migraine

• tell your doctor and pharmacist if you are allergic to Advil-Migraine (ibuprofen), aspirin or other NSAIDs such as ketoprofen and naproxen (Aleve, Naprosyn), any other medications, or any of the inactive ingredients in the type of Advil-Migraine (ibuprofen) you plan to take. Ask your pharmacist or check the label on the package for a list of the inactive ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin, in Lotrel), captopril, enalapril (Vasotec, in Vaseretic), fosinopril, lisinopril (in Zestoretic), moexipril (Univasc), perindopril (Aceon, in Prestalia), quinapril (Accupril, in Quinaretic), ramipril (Altace), and trandolapril (Mavik, in Tarka); angiotensin receptor blockers such as candesartan (Atacand, in Atacand HCT), eprosartan (Teveten), irbesartan (Avapro, in Avalide), losartan (Cozaar, in Hyzaar), olmesartan (Benicar, in Azor, in Benicar HCT, in Tribenzor), telmisartan (Micardis, in Micardis HCT, in Twynsta), and valsartan (in Exforge HCT); beta blockers such as atenolol (Tenormin, in Tenoretic), labetalol (Trandate), metoprolol (Lopressor, Toprol XL, in Dutoprol), nadolol (Corgard, in Corzide), and propranolol (Hemangeol, Inderal, Innopran); diuretics (‘water pills’); lithium (Lithobid); and methotrexate (Otrexup, Rasuvo, Trexall). Your doctor may need to change the doses of your medications or monitor you more carefully for side effects.
• do not take nonprescription Advil-Migraine (ibuprofen) with any other medication for pain unless your doctor tells you that you should.
• tell your doctor if you have or have ever had any of the conditions mentioned in the IMPORTANT WARNING section or asthma, especially if you also have frequent stuffed or runny nose or nasal polyps (swelling of the inside of the nose); heart failure; swelling of the hands, arms, feet, ankles, or lower legs; lupus (a condition in which the body attacks many of its own tissues and organs, often including the skin, joints, blood, and kidneys); or liver or kidney disease. If you are giving Advil-Migraine (ibuprofen) to a child, tell the child’s doctor if the child has not been drinking fluids or has lost a large amount of fluid from repeated vomiting or diarrhea.
• tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy; you plan to become pregnant; or you are breast-feeding. If you become pregnant while taking Advil-Migraine (ibuprofen), call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking Advil-Migraine (ibuprofen).
• if you have phenylketonuria (PKU, an inborn disease in which mental retardation develops if a specific diet is not followed), read the package label carefully before taking nonprescription Advil-Migraine (ibuprofen). Some types of nonprescription Advil-Migraine (ibuprofen) may be sweetened with aspartame, a source of phenylalanine.

Advil-Migraine dosage

A few reminders:

• When taking any medicine, always read and follow the label carefully.
• Always keep the outer carton of Advil-Migraine products.
• These ibuprofen dosage directions are for adults and children 12 years and older.
• Do not take more than directed.

How many Advil-Migraine can I take?

The usual dose for adults is two 200mg caplets a day. If this isn’t enough, your doctor may prescribe a higher dose of up to 600mg to take 4 times a day.

If you take Advil-Migraine (ibuprofen) 3 times a day, leave at least 6 hours between doses. If you take it 4 times a day, leave at least 4 hours between doses.

If you have pain all the time, your doctor may recommend slow-release Advil-Migraine (ibuprofen) tablets or capsules. It’s usual to take these once a day in the evening or twice a day. Leave a gap of 10 to 12 hours between doses if you’re taking Advil-Migraine (ibuprofen) twice a day.

For people who find it difficult to swallow tablets or capsules, Advil-Migraine (ibuprofen) is available as a tablet that melts in your mouth, granules that you mix with a glass of water to make a drink, and as a syrup.

Swallow Advil-Migraine (ibuprofen) tablets or capsules whole with a glass of water or milk. Don’t chew, break, crush or suck them as this could irritate your mouth or throat.

Always take Advil-Migraine (ibuprofen) tablets and capsules after a meal or snack or with a drink of milk. It will be less likely to upset your tummy.

What if I forget to take it?

Take the missed dose as soon as you remember, unless it’s almost time for your next dose. In this case, skip the missed dose and take your next dose as normal.

Never take a double dose to make up for a forgotten one.

If you forget doses often, it may help to set an alarm to remind you. You could also ask your pharmacist for advice on other ways to help you remember to take your medicine.

What if I take too much?

Taking too much Advil-Migraine (ibuprofen) by mouth can be dangerous. It can cause side effects such as:

• feeling sick and vomiting
• tummy pain
• feeling tired or sleepy
• black poo and blood in your vomit – a sign of bleeding in your stomach
• tinnitus (ringing in your ears)
• difficulty breathing or changes in your heart rate (slower or faster)

If you need to go to hospital, take the ibuprofen packet or leaflet inside it plus any remaining medicine with you.

Advil-Migraine Tablets

Active Ingredient: Ibuprofen 200 mg in each tablet / caplets / gel caplets

Inactive Ingredients: D&C yellow no. 10, FD&C green no. 3, FD&C red no. 40, gelatin, light mineral oil, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitan, sorbitol

Other information:

• read all warnings and directions before use. Keep carton.
• store at 20-25 °C (68-77 °F)
• avoid excessive heat above 40 °C (104 °F)

Advil-Migraine Uses

• Treats migraine

Dosing Information:

The smallest effective dose should be used

• Adults:
  • take 2 capsules with a glass of water
  • if symptoms persist of worsen, ask your doctor
  • do not take more than 2 capsules in 24 hours, unless directed by a doctor
• Under 18 years of age: Ask a doctor.

Advil-Migraine Warnings

Allergy alert

Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

• hives
• facial
• swelling
• asthma (wheezing)
• shock
• skin reddening
• rash
• blisters

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning

This product contains an nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you:

• are age 60 or older
• have had stomach ulcers or bleeding problems
• take a blood thinning (anticoagulant) or steroid drug
• take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
• have 3 or more alcoholic drinks every day while using this product
• take more or for a longer time than directed

Heart attack and stroke warning

Nonsteroidal anti-inflammatory drugs (NSAIDs), except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed

Do NOT use

• if you ever had an allergic reaction to any other pain reliever/fever reducer
• right before or after heart surgery

Ask a doctor before use if:

• stomach bleeding warning applies to you
• you have problems or serious side effects from taking pain relievers or fever reducers
• you have a history of stomach problems, such as heartburn
• you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
• you are taking a diuretic

Ask a doctor or pharmacist before use if you are:

• under a doctor’s care for any serious condition
• taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
• taking any other drug

Stop use and ask a doctor if:

• you experiences any of the following signs of stomach bleeding:
  • feel faint
  • vomits blood
  • has bloody or black stools
  • has stomach pain that does not get better
• you have symptoms of heart problems or stroke:
  • chest pain
  • trouble breathing
  • weakness in one part or side of body
  • slurred speech
  • leg swelling
• you do not get any relief within first day (24 hours) of treatment
• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present in the painful area
• any new symptoms appear

Advil-Migraine side effects

Common side effects

The common side effects of Advil-Migraine (ibuprofen) taken by mouth happen in more than 1 in 100 people. Talk to your doctor or pharmacist if these side effects bother you or don’t go away:

• headache
• feeling dizzy
• feeling sick or vomiting
• wind and indigestion
• upset stomach e.g. nausea, diarrhea and indigestion
• headache
• dizziness
• high blood pressure
• fluid retention.

There can be extra risks if you take Advil-Migraine (ibuprofen) when you are over 65, or have an ulcer, so discuss this with your doctor. Advil-Migraine (ibuprofen), like all NSAIDs, can also make heart disease worse – talk to your doctor before taking Advil-Migraine (ibuprofen) if you have any concerns.

Less common side effects include:

• feeling sleepy or anxious
• pins and needles
• problems with your eyesight
• hearing ringing in your ears
• difficulty falling asleep

Advil-Migraine (ibuprofen) tablets and capsules can cause inflammation of the stomach (gastritis) and ulcers in your stomach, gut or mouth. It can also make it difficult to breathe, or make asthma worse.

Serious side effects

Serious side effects of ibuprofen that need immediate medical attention include:

• black poo or blood in your vomit – these can be signs of bleeding in your stomach
• swollen ankles, blood in your pee or not peeing at all – these can be signs of a kidney problem
• severe chest or tummy pain – these can be signs of a hole in your stomach or gut
• difficulty breathing

This is not a full list of side effects. For more information, talk to your doctor or pharmacist. Or, if you’re experiencing a serious or life-threatening side effect, immediately call your local emergency number immediately.

Serious allergic reaction

In rare cases, it’s possible to have a serious allergic reaction to Advil-Migraine (ibuprofen).

• A serious allergic reaction is an emergency. Call your local emergency number straight away if you think you or someone around you is having a serious allergic reaction.

The warning signs of a serious allergic reaction are:

• getting a skin rash that may include itchy, red, swollen, blistered or peeling skin
• wheezing
• tightness in the chest or throat
• having trouble breathing or talking
• swelling of the mouth, face, lips, tongue, or throat

These are not all the side effects of Advil-Migraine (ibuprofen) tablets, capsules and syrup. For a full list see the leaflet inside your medicines packet.

How to cope with side effects

What to do about:

• indigestion – stop taking Advil-Migraine (ibuprofen) and see your doctor as soon as possible. If you need something to ease the discomfort, try taking an antacid, but don’t put off going to the doctor.
• feeling sick – stick to simple meals. Don’t eat rich or spicy food
• vomiting – have small, frequent sips of water. It may also help to take oral rehydration solutions like Pedialyte you can buy from a pharmacy or supermarket to prevent dehydration. Don’t take any other medicines to treat vomiting without speaking to a pharmacist or doctor.
• wind – try not to eat foods that cause wind (like pulses, lentils, beans and onions). Eat smaller meals, eat and drink slowly, and exercise regularly. There are pharmacy medicines that can also help, such as charcoal tablets or simethicone.
• your skin being sensitive to sunlight – stay out of bright sun and use a high factor sun cream (SPF 30 or above) even on cloudy days. Don’t use a sun lamp or sun beds.

Human Toxicity Reports

Gastrointestinal side effects are experienced by 5-15% of patients taking ibuprofen; epigastric pain, nausea, heartburn and sensations of “fullness” in the gastrointestinal tract are the usual difficulties ¹¹. However, the incidence of theses side effects is less with ibuprofen than with aspirin or indomethacin. Other side effects of ibuprofen have been reported less frequently. They include thrombocytopenia, skin rashes, headache, dizziness and blurred vision and in a few cases, toxic amblyopia, fluid retention and edema ¹¹.

Fatal autoimmune hemolytic anemai occurred coincident with oral administration of ibuprofen 400 mg 3 times per day in 49 yr old male ¹².

Healthy subjects treated for 2 weeks with 3 times daily ibuprofen showed a total blood loss of 9.7 ml. Mean daily blood loss was significantly higher than on placebo ¹³.

In ibuprofen overdose cases, the majority of patients had no symptoms or only mild symptoms such as nausea or vomiting. Lab analyses available for some cases demonstrate that plasma ibuprofen concentrations of up to 704 mg/L could be associated with no symptoms ¹⁴.

A case of aseptic meningoencephalitis induced by ibuprofen (Brufen) is decribed in a 24 year old unmarried woman with unrecognized systemic lupus erythematosus. The neurological manifestations induced by ibuprofen revealed the systemic disease. Clinicians confronted with aseptic meningitis or meningoencephalitis developed after treatment with a non-steroidal anti-inflammatory drug, notably ibuprofen, should investigate for systemic disease ¹⁵.

Ibuprofen (Motrin, Brufen) an anti inflammatory phenylpropionic derivative, was reported in 1971 to have caused reversible centrocecal field defects and reduced visual acuity in two patients, and a reversible “moving mosaic of colored lights in front of both eyes” in another ¹⁶. One patient was reported to have a drastic impairment of color vision & decr in visual acuity, which were largely reversible on discontinuing ibuprofen. Another patient on 2 occasions after taking ibuprofen has complained of seeing streaks shooting from lateral to central field of vision; eye exams were normal ¹⁶. Cortical visual evoked potentials were evaluated in a patient who had 20/50, 20/60 vision with decreased brightness of colors after taking ibuprofen for 2 months, showing decreased amplitudes & increased conduction times, but these became normal 6 days after the drug was stopped; vision became normal later ¹⁶.

In a series of 293 patients treated during a five year period no visual symptoms were detected that were thought attributable to the drug ¹⁶ and in another series of 247 patients there was no evidence of toxic amblyopia or maculopathy attributable to ibuprofen. A prospective study in 1975 reported no evidence of eye toxicity in 45 healthy volunteers treated for 3 months, or in 78 patients with osteoarthritis during 6 months ¹⁶.

Chemically induced renal dysfunction caused by ibuprofen is dose/duration related ¹⁷. Most common presentation renal insufficiency that can lead to acute or chronic renal failure. Cell-mediated nephrotic syndrome can occur. Short term use of moderate dose ibuprofen may result in /acute renal failure/ in patients with asymptomatic mild chronic renal failure.

Prostaglandins are known to be involved in the metabolism of bone, having a significant influence on bone resorption in cases of bone pathology ¹⁸. This study ¹⁸ investigated the short-term effects of two commonly used nonsteroidal anti-inflammatory drugs (NSAIDs), ibuprofen and acetaminophen (paracetamol), on bone resorption in healthy men. In a randomized, double-blind pilot study, 28 healthy, age- and weight-matched male volunteers were treated with ibuprofen (n = 10), acetaminophen (n = 9), or a placebo (n = 9) for 3 days. As an indication of bone resorption rate, levels of the biochemical bone markers N-telopeptide (NTx) and free deoxypyridinoline (D-Pyr) were measured in urine. Differences in resorption marker levels pre- and post-NSAID use were then compared between groups. The study authors ¹⁸ found that NTx concentrations in the acetaminophen group were lower than placebo, whereas NTx levels in the ibuprofen group were higher than in the acetaminophen group. By contrast, D-Pyr concentrations in the ibuprofen group were significantly lower than in the placebo group (p = 0.009). A comparison of the percentage changes of D-Pyr:NTx ratios found that the ratio in the ibuprofen group was significantly lower than that of both the control and acetaminophen groups. These results show the differential effects of ibuprofen and acetaminophen on urinary excretion of peptide-bound and free deoxypyridinoline cross-links of type I collagen. Short-term ibuprofen use may alter the renal handling of collagen cross-links and increase bone resorption to a greater extent than acetaminophen in normal men ¹⁸.

Advil-Migraine overdose

Can you overdose on Advil-Migraine? Yes

In case of Advil-Migraine overdose

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call your local emergency services number.

This is a free and confidential service. All local poison control centers in the United States use this national number. You should call if you have any questions about poisoning or poison prevention. You can call 24 hours a day, 7 days a week.

Symptoms of Advil-Migraine overdosage may include:

• dizziness
• fast eye movements that you cannot control
• slow breathing or short periods of time without breathing
• blue color around the lips, mouth, and nose

Symptoms may develop in the following areas:

Eyes, ears, nose, throat, and mouth:

• Ringing in the ears
• Blurred vision

Gastrointestinal:

• Diarrhea
• Heartburn
• Nausea, vomiting (sometimes bloody)
• Stomach pain (possible bleeding in stomach and intestines)

Heart and blood:

• Low blood pressure (shock) and weakness

Kidneys:

• Little to no urine production

Lungs:

• Breathing — difficult
• Breathing — slow
• Wheezing

Nervous system:

• Agitation, confusion, incoherent (not understandable)
• Drowsiness, even coma
• Convulsions
• Dizziness
• Headache (severe)
• Unsteadiness, trouble moving

Skin:

• Rash
• Sweating

Other:

• Chills

What to Expect at the Emergency Room

The health care provider will measure and monitor the person’s vital signs, including temperature, pulse, breathing rate, and blood pressure. Symptoms will be treated as appropriate. The person may receive:

• Activated charcoal
• Airway support, including oxygen, breathing tube through the mouth (intubation), and breathing machine (ventilator)
• Blood and urine tests
• Chest x-ray
• Tube through the mouth into the stomach and small intestine to identify and treat internal bleeding (endoscopy)
• EKG (electrocardiogram, or heart tracing)
• Fluids through a vein (intravenous or IV)
• Laxative
• Medicines to treat symptoms

Outlook (Prognosis)

Recovery is likely with prompt medical treatment, except in very large overdoses. Some people may develop chronic liver or kidney injury.

1. White WB, Kloner RA, Angiolillo DJ, Davidson MH. Cardiorenal Safety of OTC Analgesics. Journal of Cardiovascular Pharmacology and Therapeutics. 2018;23(2):103-118. doi:10.1177/1074248417751070. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5808827/[↩]
2. Brune K, Patrignani P. New insights into the use of currently available non-steroidal anti-inflammatory drugs. J Pain Res. 2015;8:105–118 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4346004/[↩][↩]
3. FitzGerald GA. COX-2 and beyond: approaches to prostaglandin inhibition in human disease. Nat Rev Drug Discov. 2003;2(11):879–890 https://www.nature.com/articles/nrd1225[↩][↩]
4. Brune K, Patrignani P. New insights into the use of currently available non-steroidal anti-inflammatory drugs. Journal of Pain Research. 2015;8:105-118. doi:10.2147/JPR.S75160. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4346004/[↩]
5. Stockton, D.L. and A.S. Paller. J Am Acad Dermatol 23 (1):87-103; 1990[↩]
6. J Toxicol Clin Toxicol 2003;41(4):551-2[↩][↩][↩][↩]
7. Weibert RT, Townsend RJ, Kaiser DG et al. Lack of ibuprofen secretion into human milk. Clin Pharm. 1982;1:457-8 https://www.ncbi.nlm.nih.gov/pubmed/7184678[↩][↩]
8. Townsend RJ, Benedetti TJ, Erickson SH et al. Excretion of ibuprofen into breast milk. Am J Obstet Gynecol. 1984;149:184-6 https://www.ajog.org/article/0002-9378(84)90195-9/pdf[↩][↩]
9. Walter K, Dilger C. Ibuprofen in human milk. Br J Clin Pharmacol. 1997;44:211-2[↩]
10. Rigourd V, de Villepin B, Amirouche A et al. Ibuprofen concentrations in human mature milk-First data about pharmacokinetics study in breast milk with AOR-10127 “Antalait” study. Ther Drug Monit. 2014;36:590-6 https://www.ncbi.nlm.nih.gov/pubmed/24695355[↩]
11. Hardman, J.G., L.E. Limbird, P.B. Molinoff, R.W. Ruddon, A.G. Goodman (eds.). Goodman and Gilman’s The Pharmacological Basis of Therapeutics. 9th ed. New York, NY: McGraw-Hill, 1996., p. 712[↩][↩]
12. GUIDRY JB ET AL; JAMA 242 (JUL 6): 68; 1979 https://jamanetwork.com/journals/jama/article-abstract/365628[↩]
13. WARRINGTON SJ ET AL; RHEUMATOLOGY 7 (NEW TRENDS OSTEOARTHRITIS): 107;1982[↩]
14. COURT H ET AL; HUM TOXICOL 2 (2): 381; 1983 https://www.ncbi.nlm.nih.gov/pubmed/6862484[↩]
15. Lortholary A et al; Rev Med Interne 11 (3): 243-4; 1990 https://www.ncbi.nlm.nih.gov/pubmed/2096424[↩]
16. Grant, W.M. Toxicology of the Eye. 3rd ed. Springfield, IL: Charles C. Thomas Publisher, 1986., p. 506[↩][↩][↩][↩][↩]
17. Young, L.Y., M.A. Koda-Kimble (eds.). Applied Therapeutics. The Clinical Use of Drugs. 6th ed. Vancouver, WA., Applied Therapeutics, Inc. 1995., p. 29-12[↩]
18. Head JE et al; Bone 29 (5): 437-41; 2001 https://www.ncbi.nlm.nih.gov/pubmed/11704495[↩][↩][↩][↩]

What is Cold Eeze

Cold-Eeze lozenges contain the active ingredient (per lozenge): Zincum Gluconicum 2X (13.3mg Zinc). Cold-Eeze lozenges is used to reduce the duration of the common cold and reduce the severity of cold symptoms: cough, sore throat, stuffy nose, sneezing, post nasal drip and/or hoarseness.

Cold-Eeze lozenges inactive Ingredients: Corn syrup, glycine, natural flavors and sucrose. No artificial colors or preservatives.

Zinc is a trace metal with in test tube activity against rhinovirus, the major etiologic agent in acute upper respiratory tract infections ¹, ².

Cold Eeze Warnings

Ask a doctor before use if you are taking minocycline, doxycycline, tetracycline or are on coumadin therapy, zinc treatment may inhibit the absorption of these medicines

Stop use and ask your healthcare practitioner if symptoms persist beyond 7 days.

Cold-Eeze lozenges are formulated to reduce the duration of the common cold and its symptoms and is insufficient treatment for Influenza or Allergies.

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children.

Does Cold Eeze work?

The common cold is often caused by the rhinovirus. It is one of the most widespread illnesses and is a leading cause of visits to the doctor and absenteeism from school and work. Complications of the common cold include otitis media (middle ear infection), sinusitis and exacerbations of reactive airway diseases ³. There is no proven treatment for the common cold ³. However, a medication that is even partially effective in the treatment and prevention of the common cold could markedly reduce morbidity and economic losses due to this illness.

Zinc, which can inhibit rhinovirus replication in test tube studies and has activity against other respiratory viruses such as respiratory syncytial virus ¹. The exact mechanism of zinc’s activity on viruses remains uncertain. Zinc may also reduce the severity of cold symptoms by acting as an astringent on the trigeminal nerve ⁴.

There’s been a lot of talk about taking zinc for colds ever since a 1984 study ⁵ showed that zinc supplements kept people from getting as sick. Since then, research has turned up mixed results about zinc and colds – failure of zinc gluconate in treatment of acute upper respiratory tract infections ⁶, ⁷, ⁸ and a positive result for zinc in the treatment for common colds ⁹, ¹⁰, ¹¹, ¹².

Recently analyses of several studies ¹³, ¹⁴, ¹⁵ showed that zinc lozenges or syrup reduced the length of a cold by one day, especially when taken within 24 hours of the first signs and symptoms of a cold. In a 2015 meta-analysis by Hemilä and Chalker ¹³ showed that zinc acetate lozenges shortened the duration of nasal discharge by 34%, nasal congestion by 37% , sneezing by 22%, scratchy throat by 33%, sore throat by 18%, hoarseness by 43% and cough by 46%. Zinc lozenges shortened the duration of muscle ache by 54%, but there was no difference in the duration of headache and fever ¹³. The same authors concluded that the effect of zinc acetate lozenges on cold symptoms may be associated with the local availability of zinc from the lozenges, with the levels being highest in the pharyngeal region ¹³. However their findings indicate that the effects of zinc ions are not limited to the pharyngeal region. There is no indication that the effect of zinc lozenges on nasal symptoms is less than the effect on the symptoms of the pharyngeal region, which is more exposed to released zinc ions. In some zinc lozenge trials the lozenges caused short-term adverse effects, such as bad taste, nausea, constipation, diarrhea, abdominal pain, dry mouth and oral irritation, but the bad taste can be explained by the specific lozenge composition and does not necessarily reflect the effects of zinc ions themselves ¹⁶. None of the high dose zinc acetate lozenge trials reported bad taste to be a problem and there was no substantial difference between the zinc and placebo groups in the recorded adverse effects, and only a few drop-outs occurred ¹³. Furthermore, if a common cold patient suffers from acute adverse effects such as bad taste, the patient can simply stop taking the zinc acetate lozenges. Given that the adverse effects of zinc in the 3 trials were minor, zinc acetate lozenges releasing zinc ions at doses of about 80 mg/day may be a useful treatment for the common cold, started within 24 hours, for a time period of less than two weeks ¹³.

In the USA, the recommended dietary zinc intake is 11 mg/day for men and 8 mg/day for women ¹⁷. Thus, the 80 to 92 mg/day doses used in the zinc acetate lozenge trials are substantially higher than the recommended daily intakes. However, in several clinical trials zinc has been administered to patients at a dose of 150 mg/day for months ¹⁸. A decrease in copper levels and hematological changes have been reported as adverse effects of long-term high dose zinc administration, but those changes were completely reversed with the cessation of zinc intake ¹⁹, ²⁰, ²¹, ²². Thus, given that 150 mg/day of zinc administration for months does not cause permanent harm, it seems plausible that the use of about 80 mg/day of zinc for up to two weeks in the form of zinc acetate lozenges is unlikely to cause serious adverse effects.

But the recent analysis stopped short of recommending zinc. None of the studies analyzed had enough participants to meet a high standard of proof. Also, the studies used different zinc dosages and preparations (lozenges or syrup) for different lengths of time. As a result, it’s not clear what the effective dose and treatment schedule would be.

Most colds are caused by a type of virus called rhinovirus, which thrives and multiplies in the nasal passages and throat (upper respiratory system). Zinc may work by preventing the rhinovirus from multiplying. It may also stop the rhinovirus from lodging in the mucous membranes of the throat and nose.

Zinc may be more effective when taken in lozenge or syrup form, which allows the substance to stay in the throat and come in contact with the rhinovirus.

Zinc — especially in lozenge form — also has side effects, including nausea or a bad taste in the mouth. Many people who used zinc nasal sprays suffered a permanent loss of smell. For this reason, Mayo Clinic doctors caution against using such sprays.

In addition, large amounts of zinc are toxic and can cause copper deficiency, anemia and damage to the nervous system.

For now, the safest course is to talk to your doctor before considering the use of zinc to prevent or reduce the length of colds.

Cold Eeze vs Zicam

Zicam is nasal spray is used for the temporary relief of nasal congestion associated with acute and chronic rhinitis or stuffiness caused by hay fever or other allergies and common colds. Zicam is also used to relieve sinus congestion and pressure. Zicam active ingredient is called Oxymetazoline hydrochloride. Zicam (Oxymetazoline) is a selective α_2A-adrenergic receptor agonist a sympathomimetic amine in a class of medications called nasal decongestants. It is used as a topical vasoconstrictor. Zicam (Oxymetazoline) works by narrowing the blood vessels (vasoconstriction) in the nasal passages, thus decreasing nasal blood flow and nasal congestion.

Zicam nasal spray does not contain any zinc. Zicam (Oxymetazoline) nasal spray should not be used to treat children younger than 6 years of age unless it is recommended by a doctor. Children 6 to 12 years of age should only use Zicam (Oxymetazoline) nasal spray carefully and under adult supervision.

Zicam (Oxymetazoline) may also be used for other conditions as determined by your doctor.

Zicam (Oxymetazoline) is available without a prescription.

Zicam Uses

• Temporarily relieves nasal congestion due to:
  • the common cold
  • hay fever
  • upper respiratory allergies
• Temporarily relieves sinus congestion and pressure
• Helps clear nasal passages
• Shrinks swollen membranes

Zicam (Oxymetazoline) is available in the following dosage forms:

• Nasal Solution
• Nasal Spray

Directions of use

• Adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
• Children under 6 years of age: Ask a doctor

To use pump:

• to open, hold the actuator to squeeze and turn cap
• hold with thumb at bottom of bottle and nozzle between fingers
• before using the first time, prime pump by depressing several times
• place tip of nozzle just past nasal opening (approximately 1/8″)
• pump 2 or 3 times in each nostril without tilting your head. Sniff deeply.
• wipe nozzle clean after use
• to close, turn cap until it ‘clicks’

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Cold-Eeze directions

• Do NOT take Cold-Eeze lozenges on an empty stomach to avoid possible minor stomach upset. Avoid taking Cold-Eeze lozenges with foods that are high in calcium or phosphorus, which can make it harder for your body to absorb zinc gluconate. Foods high in calcium or phosphorus include milk, cheese, yogurt, ice cream, dried beans or peas, lentils, nuts, peanut butter, beer, cola soft drinks, and hot cocoa.
• Do NOT eat or drink for 15 minutes after use.
• store in a cool, dry place after opening
• gluten-free

Cold-Eeze dosage

• Adults and children 12 years and over:
  • take Cold-Eeze when you have cold symptoms
  • completely dissolve a Cold-Eeze lozenge in mouth (do not chew)
  • repeat every 2-4 hours as needed until all symptoms subside
  • recommended daily dosage is 6 lozenges for adults and 4 lozenges for ages 12-17
• Children under 12 years of age should consult a health professional prior to use

Cold Eeze side effects

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get emergency medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect.

Get emergency medical help if you have any of these signs of an allergic reaction:

• hives;
• rash;
• red, swollen, blistered, or peeling skin with or without fever;
• wheezing;
• tightness in the chest or throat;
• trouble breathing, swallowing, or talking; unusual hoarseness;
• swelling of the mouth, face, lips, tongue, or throat.

Less serious side effects may include:

• nausea; or
• upset stomach.

High zinc intakes can inhibit copper absorption, sometimes producing copper deficiency and associated anemia ²³, ²⁴. For this reason, dietary supplement formulations containing high levels of zinc, such as the one used in the Age-Related Eye Disease Study Research Group (AREDS) study ²⁵, sometimes contain copper.

Endocrine

Endocrine side effects have included the reduction of high density lipoprotein (HDL) “good cholesterol” in males.

Due to an accompanying decrease in low density lipoproteins (LDL), the LDL/HDL ratio remains relatively unchanged and little risk is assumed in terms of coronary heart disease. Triglyceride levels have not been shown to be affected.

Gastrointestinal

Gastrointestinal irritation appears to be dose-related.

Gastrointestinal side effects have included an unpleasant taste (80%), nausea (20%), mouth irritation (24%), dry mouth (12%), gastrointestinal upset (10%), distortion of taste, abdominal pain, vomiting, and diarrhea.

Nervous system

Nervous system side effects have rarely included dizziness and headache.

1. Suara RO, Crowe JE., Jr Effect of zinc salts on respiratory syncytial virus replication. Antimicrob Agents Chemother 2004;48: 783–90 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC353050/[↩][↩]
2. Gwaltney, J. M., Jr. 1979. The common cold, p. 429-435. In G. L. Mandell, R. G. Douglas, and J. E. Bennett (ed.), Principles and practice of infectious diseases. John Wiley & Sons, Inc., New York.[↩]
3. Singh M, Das RR. Zinc for the common cold. Cochrane Database of Systematic Reviews 2011, Issue 2. Art. No.: CD001364. DOI: 10.1002/14651858.CD001364.pub3 http://cochranelibrary-wiley.com/doi/10.1002/14651858.CD001364.pub3/full[↩][↩]
4. Novick SG, Godfrey JC, Godfrey NJ, et al. How does zinc modify the common cold? Clinical observations and implications regarding mechanisms of action. Med Hypotheses 1996;46:295–302 https://www.ncbi.nlm.nih.gov/pubmed/8676770[↩]
5. Couch RB. The common cold control?. Journal of Infectious Diseases 1984;150:167-73. https://www.ncbi.nlm.nih.gov/pubmed/6206168[↩]
6. Smith DS, Helzner EC, Nuttall CE, et al. Failure of zinc gluconate in treatment of acute upper respiratory tract infections. Antimicrobial Agents and Chemotherapy. 1989;33(5):646-648. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC172506/pdf/aac00073-0070.pdf[↩]
7. Farr BM, Conner EM, Betts RF, Oleske J, Minnefor A, Gwaltney JM. Two randomized controlled trials of zinc gluconate lozenge therapy of experimentally induced rhinovirus colds. Antimicrobial Agents and Chemotherapy. 1987;31(8):1183-1187. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC174900/pdf/aac00098-0045.pdf[↩]
8. Douglas RM, Miles HB, Moore BW, Ryan P, Pinnock CB. Failure of effervescent zinc acetate lozenges to alter the course of upper respiratory tract infections in Australian adults. Antimicrobial Agents and Chemotherapy. 1987;31(8):1263-1265. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC174915/pdf/aac00098-0125.pdf[↩]
9. Prophylaxis and treatment of rhinovirus colds with zinc gluconate lozenges. J Antimicrob Chemother. 1987 Dec;20(6):893-901. https://www.ncbi.nlm.nih.gov/pubmed/3440773[↩]
10. Zinc gluconate lozenges for treating the common cold. A randomized, double-blind, placebo-controlled study. Ann Intern Med. 1996 Jul 15;125(2):81-8. http://annals.org/aim/article-abstract/709805/zinc-gluconate-lozenges-treating-common-cold-randomized-double-blind-placebo?volume=125&issue=2&page=81[↩]
11. Duration of symptoms and plasma cytokine levels in patients with the common cold treated with zinc acetate. A randomized, double-blind, placebo-controlled trial. Duration of symptoms and plasma cytokine levels in patients with the common cold treated with zinc acetate. A randomized, double-blind, placebo-controlled trial. http://annals.org/aim/fullarticle/713796/zinc-acetate-lozenges-treat-common-cold[↩]
12. Zinc gluconate lozenges for common cold. A double-blind clinical trial. Dan Med Bull. 1990 Jun;37(3):279-81. https://www.ncbi.nlm.nih.gov/pubmed/2192839/[↩]
13. Hemilä H, Chalker E. The effectiveness of high dose zinc acetate lozenges on various common cold symptoms: a meta-analysis. BMC Family Practice. 2015;16:24. doi:10.1186/s12875-015-0237-6. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4359576/[↩][↩][↩][↩][↩][↩]
14. Science M, Johnstone J, Roth DE, Guyatt G, Loeb M. Zinc for the treatment of the common cold: a systematic review and meta-analysis of randomized controlled trials. CMAJ : Canadian Medical Association Journal. 2012;184(10):E551-E561. doi:10.1503/cmaj.111990. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3394849/[↩]
15. Singh M, Das RR. Zinc for the common cold. Cochrane Database of Systematic Reviews 2011, Issue 2. Art. No.: CD001364. DOI: 10.1002/14651858.CD001364.pub3. http://cochranelibrary-wiley.com/doi/10.1002/14651858.CD001364.pub3/full[↩]
16. Zinc lozenges: cold cure or candy? Solution chemistry determinations. Eby GA. Biosci Rep. 2004 Feb; 24(1):23-39. https://www.ncbi.nlm.nih.gov/pubmed/15499830/[↩]
17. National Research Council . Dietary Reference Intakes for Vitamin A, Vitamin K, Arsenic, Boron, Chromium, Copper, Iodine, Iron, Manganese, Molybdenum, Nickel, Silicon, Vanadium, and Zinc. Washington, DC: The National Academies Press; 2001. p. 475.[↩]
18. Randomized, double-blind trial of 220 mg zinc sulfate twice daily in the treatment of rosacea. Bamford JT, Gessert CE, Haller IV, Kruger K, Johnson BP. Int J Dermatol. 2012 Apr; 51(4):459-62. https://www.ncbi.nlm.nih.gov/pubmed/22435439/[↩]
19. Samman S, Roberts DC. The effect of zinc supplements on plasma zinc and copper levels and the reported symptoms in healthy volunteers. Med J Aust. 1987;146:246–9. https://www.ncbi.nlm.nih.gov/pubmed/3547053[↩]
20. Prasad AS, Brewer GJ, Schoomaker EB, Rabbani P. Hypocupremia induced by zinc therapy in adults. JAMA. 1978;240:2166–8. doi: 10.1001/jama.1978.03290200044019 https://www.ncbi.nlm.nih.gov/pubmed/359844[↩]
21. Hoffman HN, Phyliky RL, Fleming CR. Zinc-induced copper deficiency. Gastroenterology. 1988;94:508–12 https://www.ncbi.nlm.nih.gov/pubmed/3335323[↩]
22. Forman WB, Sheehan D, Cappelli S, Coffman B. Zinc abuse: an unsuspected cause of sideroblastic anemia. West J Med. 1990;152:190–2 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1002314/pdf/westjmed00114-0084.pdf[↩]
23. Broun ER, Greist A, Tricot G, Hoffman R. Excessive zinc ingestion. A reversible cause of sideroblastic anemia and bone marrow depression. JAMA 1990;264:1441-3. https://www.ncbi.nlm.nih.gov/pubmed/2094240?dopt=Abstract[↩]
24. Willis MS, Monaghan SA, Miller ML, McKenna RW, Perkins WD, Levinson BS, et al. Zinc-induced copper deficiency: a report of three cases initially recognized on bone marrow examination. Am J Clin Pathol 2005;123:125-31. https://www.ncbi.nlm.nih.gov/pubmed/15762288?dopt=Abstract[↩]
25. Age-Related Eye Disease Study Research Group. A randomized, placebo-controlled, clinical trial of high-dose supplementation with vitamins C and E, beta carotene, and zinc for age-related macular degeneration and vision loss: AREDS report no. 8. Arch Ophthalmol 2001;119:1417-36. https://www.ncbi.nlm.nih.gov/pubmed/11594942?dopt=Abstract[↩]

What is Emetrol

Emetrol is a phosphorated carbohydrate (sugar) solution used for the relief of upset stomach associated with nausea due to overindulgence in food and drink. Emetrol active ingredients in each 5 mL are: 1.87 g Dextrose (glucose) + 1.87 g Levulose (fructose) + 21.5 mg Phosphoric acid

Inactive ingredients: FD&C red no. 40, flavors, glycerin, methylparaben, and purified water.

Emetrol Warnings

This product contains fructose and should not be taken by persons with hereditary fructose intolerance.

Do not use if you have:

• allergic reactions to any of the ingredients in this product

Ask a doctor before use if you have:

• diabetes

Stop use and ask a doctor if:

• symptoms persist, return or get worse

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

How does Emetrol work

Glucose is a simple sugar (monosaccharide) that is a primary source of energy for living organisms. Glucose is naturally occurring and is found in fruits and other parts of plants in its free state. Glucose is used therapeutically in fluid and nutrient replacement. In your body glucose arises from the breakdown of glycogen in a process known as glycogenolysis. Glucose is synthesized in the liver and kidneys from non-carbohydrate intermediates, such as pyruvate and glycerol, by a process known as gluconeogenesis.

Fructose is a simple sugar (monosaccharide) found in sweet fruits and honey that is soluble in water, alcohol, or ether. Fructose is used as a preservative and an intravenous infusion in parenteral feeding.

Phosphoric Acid is a colorless, odorless phosphorus-containing inorganic acid. Phosphoric acid is a sequestering agent which binds many divalent cations, including Fe++, Cu++, Ca++, and Mg++. Phosphoric acid is used in dentistry and orthodontics as an etching solution, to clean and roughen the surfaces of teeth where dental appliances or fillings will be placed. In addition, phosphoric acid is a constituent in bone and teeth, and plays a role in many metabolic processes.

What do I need to tell my doctor BEFORE I take Emetrol?

• If you have an allergy to fructose, dextrose, phosphoric acid, or any other part of Emetrol (fructose, dextrose, and phosphoric acid).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you are not able to break down fructose.

This is not a list of all drugs or health problems that interact with Emetrol (fructose, dextrose, and phosphoric acid).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Emetrol (fructose, dextrose, and phosphoric acid) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Emetrol?

• Tell all of your health care providers that you take Emetrol (fructose, dextrose, and phosphoric acid). This includes your doctors, nurses, pharmacists, and dentists.
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
• Different brands of Emetrol (fructose, dextrose, and phosphoric acid) may be for use in different ages of children. Talk with the doctor before giving Emetrol (fructose, dextrose, and phosphoric acid) to a child.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Emetrol (fructose, dextrose, and phosphoric acid) while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Is Emetrol safe for pregnancy?

There is no research data regarding the safety of Emetrol (fructose, dextrose, and phosphoric acid) for use during pregnancy or while pregnant or to treat early pregnancy morning sickness. If you’re pregnant or breast-feeding, you should consult with your doctor before using Emetrol. Furthermore, Emetrol (fructose, dextrose, and phosphoric acid) has not been found by the U.S. Food and Drug Administration (FDA) to be safe and effective, and their labeling has not been approved by FDA. For further information about unapproved drugs, please visit the FDA’s Unapproved Prescription Drugs: Drugs Marketed in the United States That Do Not Have Required FDA Approval, here https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/default.htm.

How is Emetrol best taken?

Use Emetrol (fructose, dextrose, and phosphoric acid) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Measure liquid doses carefully. Use the measuring device that comes with Emetrol (fructose, dextrose, and phosphoric acid). If there is none, ask the pharmacist for a device to measure Emetrol (fructose, dextrose, and phosphoric acid).
• Do not mix with any liquid.
• Do not drink any other liquids right before or after taking Emetrol (fructose, dextrose, and phosphoric acid).

Emetrol dosage

• for maximum effectiveness never dilute or drink fluids of any kind immediately before or after taking Emetrol (fructose, dextrose, and phosphoric acid)
• Adults and children 12 years of age and over: one to two tablespoons (15 ml to 30 ml)
• Children 2 to under 12 years of age: one or two teaspoons (5 ml to 10 ml)
• repeat dose every 15 minutes or until distress subsides
• do not take more than 5 doses in 1 hour without consulting a doctor
• measure only with dosing cup provided. Dosing cup to be used with Emetrol only. Do not use with other products.

Other information

• Store between 20-25ºC (68-77ºF) away from heat and direct light; keep from freezing
• Do not use if printed foil seal under bottle cap is broken or missing

What do I do if I miss a dose?

• Emetrol (fructose, dextrose, and phosphoric acid) is taken on an as needed basis. Do not take more often than told by the doctor.
• Do not take more than 5 doses in 1 hour unless told to do so by your doctor.

Emetrol side effects

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

Along with its needed effects, phosphorated carbohydrate solution (the active ingredient contained in Emetrol) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Stop taking phosphorated carbohydrate solution and get emergency help immediately if any of the following effects occur:

Signs of fructose intolerance

• fainting
• swelling of face, arms, and legs
• unusual bleeding
• vomiting
• weight loss
• yellow eyes or skin

Some side effects of phosphorated carbohydrate solution may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common – more common with large doses

• diarrhea
• stomach or abdominal pain

Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

Signs of an allergic reactions are:

• rash;
• hives;
• itching; red, swollen, blistered, or peeling skin with or without fever;
• wheezing;
• tightness in the chest or throat;
• trouble breathing, swallowing, or talking;
• unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

If OVERDOSE is suspected:

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. Be ready to tell or show what was taken, how much, and when it happened.

This is a free and confidential service. All local poison control centers in the United States use this national number. You should call if you have any questions about poisoning or poison prevention. You can call 24 hours a day, 7 days a week.

What is Cepacol

Cepacol is a brand that has many different products. For example, there are Cepacol Sore Throat Lozenges and Cepacol Mouthwash.

Cepacol Sore Throat and Cough Mixed Berry Lozenges

Active Ingredients (in each lozenge): Benzocaine 7.5 mg [local anesthetic] + Dextromethorphan hydrobromide 5 mg [cough suppressant]

Inactive ingredients: FD&C blue no. 1, FD&C red no. 40, flavors, isomalt, maltitol, propylene glycol, purified water, sodium bicarbonate, sucralose

Uses: Temporarily relieves:

• cough due to minor throat and bronchial irritation as may occur with the common cold
• sore throat
• sore mouth
• minor mouth irritation
• pain associated with canker sores

Purpose: Oral pain reliever and cough suppressant

Cepacol Sore Throat and Cough Mixed Berry Lozenges Dosage

• Adults and Children 12 years or older: take 2 lozenges (one immediately after the other) and allow each lozenge to dissolve slowly in the mouth; may be repeated every 4 hours, not to exceed 12 lozenges in any 24-hour period, or as directed by a doctor
• Children under 6 years of age: DO NOT USE

Cepacol Extra Strength Sore Throat Cherry Lozenges

Active Ingredients (in each lozenge): Benzocaine 15 mg [local anesthetic] + Menthol 3.6 mg [cooling sensation]

Inactive ingredients: D&C red no. 33, FD&C red no. 40, flavors, isomalt, maltitol, purified water, sodium bicarbonate, sucralose

Uses: Temporary relief of occasional:

• sore throat
• sore mouth
• minor mouth irritation
• pain associated with canker sores

Purpose: Oral pain reliever

Cepacol Extra Strength Sore Throat Cherry Lozenges Dosage

• Adults and Children 5 years or older: allow lozenge to dissolve slowly in the mouth; may be repeated every 2 hours as needed or as directed by a doctor or dentist.
• Children under 5 years of age: DO NOT USE

Cepacol Extra Strength Sore Throat Tangerine Lozenges

Active Ingredients (in each lozenge): Benzocaine 15 mg [local anesthetic] + Menthol 2.3 mg [cooling sensation]

Inactive ingredients: FD&C yellow no. 6, flavors, isomalt, maltitol, propylene glycol, purified water, sodium bicarbonate, sucralose

Uses: Temporary relief of occasional:

• sore throat
• sore mouth
• minor mouth irritation
• pain associated with canker sores

Purpose: Oral pain reliever

Cepacol Extra Strength Sore Throat Tangerine Lozenges Dosage

• Adults and Children 5 years or older: allow lozenge to dissolve slowly in the mouth; may be repeated every 2 hours as needed or as directed by a doctor or dentist.
• Children under 5 years of age: DO NOT USE

Cepacol Extra Strength Sore Throat Honey Lemon Lozenges

Active Ingredients (in each lozenge): Benzocaine 15 mg [local anesthetic] + Menthol 2.5 mg [cooling sensation]

Inactive ingredients: D&C yellow no. 10, FD&C yellow no. 6, flavors, isomalt, maltitol, propylene glycol, purified water, sodium bicarbonate, sucralose

Uses: Temporary relief of occasional:

• sore throat
• sore mouth
• minor mouth irritation
• pain associated with canker sores

Purpose: Oral pain reliever

Cepacol Extra Strength Sore Throat Honey Lemon Lozenges Dosage

• Adults and Children 5 years or older: allow lozenge to dissolve slowly in the mouth; may be repeated every 2 hours as needed or as directed by a doctor or dentist.
• Children under 5 years of age: DO NOT USE

Cepacol Mouthwash

Active Ingredients: Cetylpyridinium chloride 0.05%

Inactive ingredients: purified water, alcohol 14% v/v, glycerin, sodium phosphate dibasic, eucalyptus oil, polysorbate 80, methyl salicylate, cinnamon oil, peppermint oil, saccharin sodium, sodium phosphate monobasic anhydrous, menthol, edetate disodium, FD&C Yellow #5

Uses: Helps prevent and reduce plaque that leads to:

• gingivitis, an early form of gum disease
• bleeding gums

Purpose: Antigingivitis/Antiplaque

Cepacol Mouthwash Warnings

Stop use and ask a dentist if:

• gingivitis, bleeding, or redness persists for more than 2 weeks
• you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.

Keep out of the reach of children under 6 years of age. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Cepacol Mouthwash Directions of Use

• This rinse is not intended to replace brushing or flossing
• Adults and children 12 years of age and older: vigorously swish 20 milliliters of rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse
• Children 6 years to under 12 years of age: Supervise use
• Children under 6 years of age: DO NOT USE

What is Dextromethorphan?

Dextromethorphan is a cough suppressant. It affects the signals in the brain that trigger cough reflex.

Dextromethorphan is used to treat a cough.

Dextromethorphan will not treat a cough that is caused by smoking, asthma, or emphysema.

Dextromethorphan Important information

Do not give dextromethorphan to a child younger than 4 years old.

Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Do not use dextromethorphan if you have used an monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take dextromethorphan before the monoamine oxidase inhibitor (MAOI) has cleared from your body.

Do not use any other over-the-counter cough, cold, or allergy medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains dextromethorphan. Dextromethorphan will not treat a cough that is caused by smoking, asthma, or emphysema.

Before taking Dextromethorphan

Do not use dextromethorphan if you have used an monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take dextromethorphan before the MAO inhibitor has cleared from your body.

Ask a doctor or pharmacist about using dextromethorphan if you have emphysema or chronic bronchitis.

Dextromethorphan may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Dextromethorphan may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Artificially-sweetened liquid forms of cough medicine may contain phenylalanine. This would be important to know if you have phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about phenylalanine.

What should I avoid?

Avoid drinking alcohol. It can increase some of the side effects of dextromethorphan. This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor’s advice. Taking a stimulant together with cough medicine can increase your risk of unpleasant side effects.

Do not use any other over-the-counter cough, cold, or allergy medication without first asking your doctor or pharmacist. Dextromethorphan is contained in many combination medicines available over the counter. If you take certain products together you may accidentally take too much of this medicine. Read the label of any other medicine you are using to see if it contains dextromethorphan.

What other drugs will affect dextromethorphan?

Before taking dextromethorphan, tell your doctor if you are using any of the following drugs:

• celecoxib (Celebrex);
• cinacalcet (Sensipar);
• darifenacin (Enablex);
• imatinib (Gleevec);
• quinidine (Quinaglute, Quinidex);
• ranolazine (Ranexa)
• ritonavir (Norvir);
• sibutramine (Meridia);
• terbinafine (Lamisil);
• medicines to treat high blood pressure; or
• antidepressant medications such as amitriptyline (Elavil, Etrafon), bupropion (Wellbutrin, Zyban), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), imipramine (Janimine, Tofranil), paroxetine (Paxil), sertraline (Zoloft), and others.

This list is not complete and there may be other drugs that can interact with dextromethorphan. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Dextromethorphan side effects

Along with its needed effects, dextromethorphan may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. Less serious side effects are more likely, such as stomach upset.

General side effects

• Adverse effects have included gastrointestinal disturbances such as stomach upset and diarrhea.

Nervous system

• Frequency not reported: Drowsiness, dizziness, convulsions

Respiratory

• Frequency not reported: Respiratory depression

Gastrointestinal

• Frequency not reported: Vomiting, nausea, diarrhea, abdominal pain, gastrointestinal disturbance

Hypersensitivity

• Rare (less than 0.1%): Fixed-drug eruptions

Psychiatric

• Cases of abuse have been reported.
• Frequency not reported: Mental confusion, excitation, insomnia, abuse

Dermatologic

• Frequency not reported: Rash, angioedema, pruritus, urticaria

Check with your doctor as soon as possible if any of the following side effects occur while taking dextromethorphan:

Symptoms of dextromethorphan overdose:

• blurred vision
• confusion
• difficulty in urination
• drowsiness or dizziness
• nausea or vomiting (severe)
• shakiness and unsteady walk
• slowed breathing
• unusual excitement, nervousness, restlessness, or irritability (severe)

Some side effects of dextromethorphan may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common or rare side effects:

• confusion
• constipation
• dizziness (mild)
• drowsiness (mild)
• headache
• nausea or vomiting
• stomach pain

Get emergency medical help if you have any of these signs of an allergic reaction:

• hives;
• difficulty breathing;
• swelling of your face, lips, tongue, or throat.

Stop using dextromethorphan and call your doctor at once if you have any of these serious side effects:

• severe dizziness, anxiety, restless feeling, or nervousness;
• confusion, hallucinations; or
• slow, shallow breathing.

What is Benzocaine?

Benzocaine is a local anesthetic (numbing medication) that acts by preventing transmission of impulses along nerve fibers and at nerve endings that is commonly used as a topical pain reliever. Cepacol Sore Throat Lozenges (Benzocaine) is an ester of paraaminobenzoic acid, with anesthetic activity. Benzocaine binds to the sodium channel and reversibly stabilizes the neuronal membrane which decreases its permeability to sodium ions. Depolarization of the neuronal membrane is inhibited, thereby blocking the initiation and conduction of nerve impulses along nerve fibers and at nerve endings. The action of benzocaine is completely reversible.

What is Methemoglobinemia?

Methemoglobinemia (MetHb) is a blood disorder in which an abnormal amount of methemoglobin is produced ⁵. Hemoglobin is the protein in red blood cells (RBCs) that carries and distributes oxygen to the body. Methemoglobin is a form of hemoglobin. With methemoglobinemia, the hemoglobin can carry oxygen, but is not able to release it effectively to body tissues.

Danger signs and symptoms of methemoglobinemia include:

• pale, gray, or blue-colored skin, lips and nail beds
• shortness of breath
• fatigue
• confusion
• headache
• light-headedness
• rapid heart rate

Symptoms can occur within minutes to hours after benzocaine use. They can occur after using the drug for the first time, as well as after several uses.

If your child has any of these symptoms after using benzocaine, stop using the product and seek medical help immediately by calling your local emergency services number for an ambulance.

Methemoglobinemia caused by benzocaine may require treatment with medications and admission to a hospital. Serious cases should be treated right away. If left untreated or if treatment is delayed, methemoglobinemia may cause permanent injury to the brain and body tissues, and even death, from the insufficient amount of oxygen in the blood.

Complications of methemoglobinemia include ⁶:

• Shock
• Seizures
• Death

Methemoglobinemia Exams and Tests ⁶

A baby with this condition will have a bluish skin color (cyanosis). The health care provider will perform blood tests to diagnose the condition. Tests may include:

• Checking the oxygen level in the blood (pulse oximetry)
• Blood test to check levels of gases in the blood (arterial blood gas analysis)

Methemoglobinemia Treatment ⁶

A medicine called methylene blue is used to treat severe methemoglobinemia. Methylene blue may be unsafe in people who have or may be at risk for a blood disease called glucose-6-phosphate dehydrogenase (G6PD). They should not take this medicine. If you or your child has glucose-6-phosphate dehydrogenase (G6PD), always tell your provider before getting treatment.

Ascorbic acid may also be used to reduce the level of methemoglobin.

Alternative treatments include hyperbaric oxygen therapy, red blood cell transfusion and exchange transfusions.

In most cases of mild acquired methemoglobinemia, no treatment is needed. But you should avoid the medicine or chemical that caused the problem. Severe cases may need a blood transfusion.

Outlook (Prognosis)

People with acquired methemoglobinemia often do very well once the drug, food, or chemical that caused the problem is identified and avoided ⁶.

Important Information Before Using Cepacol Sore Throat Lozenges

Cepacol Sore Throat Lozenges (Benzocaine) used in the mouth or throat may cause methemoglobinemia, a life-threatening condition in which the amount of oxygen in your blood stream becomes dangerously low. Do not use this medicine if you have ever had methemoglobinemia.

GET EMERGENCY MEDICAL HELP IF YOU HAVE SYMPTOMS OF METHEMOGLOBINEMIA: headache, tired feeling, confusion, fast heart rate, and feeling light-headed or short of breath, with a pale, blue, or gray appearance of your skin, lips, or fingernails.

• Do not use this medicine on a child younger than 2 years old without medical advice.

An overdose of numbing medications can cause fatal side effects if too much of the medicine is absorbed through your skin and into your blood. Use the smallest amount of this medication needed.

Ask a doctor or pharmacist if it is safe for you to use Cepacol Sore Throat Lozenges (Benzocaine) if you have:

• asthma, bronchitis, emphysema, or other breathing disorder;
• heart disease;
• a personal or family history of methemoglobinemia, or any genetic (inherited) enzyme deficiency; or
• if you smoke.

It is not known whether Cepacol Sore Throat Lozenges (Benzocaine) topical will harm an unborn baby. Ask a doctor before using this medicine if you are pregnant.

It is not known whether Cepacol Sore Throat Lozenges (Benzocaine) topical passes into breast milk or if it could affect a nursing baby. Ask a doctor before using this medicine if you are breast-feeding.

Benzocaine Precautions

• Benzocaine topical is considered contraindicated in patients with congenital or idiopathic methemoglobinemia.
• Benzocaine should not be used in infants less than 12 months of age who are receiving treatment with methemoglobin- inducing agents.
• Benzocaine topical is for external use only, and is not intended to be used in or near the eyes.
• Benzocaine crystals may appear as a white precipitate following topical application.
• Do not apply in large quantities or over large, raw, or blistered areas,
• Benzocaine topical is not intended for use on deep or puncture wounds, or serious burns.
• Instruct patients to avoid eating for approximately 1 hour following topical application to oral mucosa.
• Safety and effectiveness of benzocaine sore throat lozenges have not been established in children less than 5 years of age.

Cepacol side effects

Cepacol Sore Throat Lozenges (Benzocaine) used in the mouth or throat may cause a rare but life-threatening condition called methemoglobinemia. In this condition, the amount of oxygen in your blood stream becomes dangerously low. This condition may occur after only one use of benzocaine or after several uses.

Signs and symptoms may occur within minutes or up to 2 hours after using Cepacol Sore Throat Lozenges (Benzocaine) in the mouth or throat.

GET EMERGENCY MEDICAL HELP IF YOU HAVE:

• headache, tired feeling, confusion;
• fast heart rate;
• feeling light-headed or short of breath; and
• pale, blue, or gray appearance of your skin, lips, or fingernails.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using Cepacol Sore Throat Lozenges (Benzocaine) and call your doctor at once if you have:

• severe burning, stinging, or sensitivity where the medicine is applied;
• swelling, warmth, or redness; or
• oozing, blistering, or any signs of infection.

Common side effects may include:

• mild stinging, burning, or itching where the medicine is applied;
• skin tenderness or redness; or
• dry white flakes where the medicine was applied.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch/default.htm) or by phone (1-800-332-1088).

Along with its needed effects, benzocaine topical (the active ingredient contained in Cepacol Sore Throat Lozenges) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking benzocaine topical:
Incidence not known

• Headache
• High fever
• Nausea
• Vomiting
• Worsening of pain, redness, swelling, or irritation in or around the mouth

Side effects apply to benzocaine topical: compounding powder, mucous membrane gel, mucous membrane liquid, mucous membrane lozenge, mucous membrane paste, mucous membrane powder for reconstitution, mucous membrane spray, mucous membrane swab, mucous membrane tablet disintegrating, rectal ointment, rectal suppository, topical cream, topical gel, topical liquid, topical lotion, topical ointment, topical spray, topical stick, topical swab

Dermatologic

• Dermatologic side effects have included contact dermatitis and urticaria.

Local

• Local side effects have included burning and stinging.

Other

• Other side effects have included edema.

Cardiovascular

• Cardiovascular side effects have included angioedema.

Hematologic

• Hematologic side effects have included methemoglobinemia. FDA continues to receive reports of methemoglobinemia from postmarketing reporting.

1. Risk of serious and potentially fatal blood disorder prompts FDA action on oral over-the-counter benzocaine products used for teething and mouth pain and prescription local anesthetics. https://www.fda.gov/Drugs/DrugSafety/ucm608265.htm[↩]
2. Teething: 4 to 7 Months. https://www.healthychildren.org/English/ages-stages/baby/teething-tooth-care/pages/Teething-4-to-7-Months.aspx[↩]
3. FDA confirms elevated levels of belladonna in certain homeopathic teething products. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm538684.htm[↩]
4. https://www.ada.org/~/media/ADA/Publications/Files/ADA_PatientSmart_Mouth_Sores.pdf?la=en[↩]
5. Hartman NR, Mao JJ, Zhou H, Boyne MT, Wasserman AM, Taylor K, Racoosin JA, Patel V, Colatsky T. More methemoglobin is produced by benzocaine treatment than lidocaine treatment in human in vitro systems. Regul Toxicol Pharmacol 2014; 70:182-8.[↩]
6. Methemoglobinemia. https://medlineplus.gov/ency/article/000562.htm[↩][↩][↩][↩]

What is Gaviscon

Gaviscon is a type of medicine called a ‘reflux suppressant’ that is indicated for the treatment of heartburn (acid reflux) and indigestion. Acid reflux (heartburn) is when stomach acid travels up your food pipe (esophagus) and gives you a burning feeling in your chest. Reflux suppressants like Gaviscon contain alginic acid which is made from seaweed. Alginic acid makes a protective foam layer that floats on top of the contents of your stomach. This stops stomach acid escaping into your food pipe. Gaviscon also contains an antacid that neutralizes excess stomach acid and reduces pain and discomfort.

There are different types of Gaviscon. Ask your doctor or pharmacist which one is best for you.

Gaviscon is used for the relief of:

• heartburn
• acid indigestion
• sour stomach
• upset stomach associated with these symptoms

Gaviscon comes as tablets or liquid in bottles or sachets. It also comes as a powder for babies and children under 2 years old.

You can buy Gaviscon from pharmacies and supermarkets. Some kinds of Gaviscon are available on prescription.

Key facts

• It’s usual to take Gaviscon after meals and at bedtime.
• Do not give Gaviscon to a child under 12 years old, unless their doctor prescribes it.
• It’s safe to take paracetamol at the same time as Gaviscon but don’t have ibuprofen or aspirin with it.
• If you’ve bought Gaviscon without a prescription, do not take it for longer than 7 days without checking with a doctor.
• There are many different types of Gaviscon. Ask your doctor or pharmacist which one is best for you.

When will I feel better after taking Gaviscon?

You should start to feel better soon after taking a dose of Gaviscon. The effect of 1 dose should last for around 4 hours.

If you’ve bought Gaviscon to treat yourself and you don’t feel better after taking it for 7 days, tell your doctor. They may want to do tests or try a different medicine.

Can I drink alcohol with Gaviscon?

Alcohol doesn’t interfere with the way Gaviscon works. But drinking alcohol makes your stomach produce more acid than normal. This can irritate your stomach lining and make your symptoms worse.

Is it safe to take Gaviscon for a long time?

Gaviscon doesn’t usually cause problems when you take it for a long time. Tell your doctor if you need to take it regularly for more than a week.

Are there other indigestion medicines?

There are a number of different medicines for indigestion and heartburn.

• Antacids include Tums (calcium carbonate), Maalox and Milk of Magnesia. These relieve indigestion and heartburn by neutralising the acid in your stomach. They work quickly and make you feel better for a few hours. They’re ideal if you occasionally get stomach acid problems. You can get antacids from pharmacies and supermarkets.
• Proton pump inhibitors (PPIs) reduce the amount of acid your stomach produces. Most PPIs are available on prescription only – they include omeprazole and lansoprazole. You can buy the lowest strength omeprazole and esomeprazole from pharmacies.
• Histamine antagonists (also called H2 blockers) reduce the amount of acid made in your stomach, but they do this in a different way to PPIs. For example, your doctor might prescribe ranitidine (Zantac), cimetidine (Tagamet), famotidine (Pepcid) and nizatidine (Axid). You can also buy famotidine and ranitidine from pharmacies.

Can I take Gaviscon with a proton pump inhibitor?

If your doctor has prescribed a proton pump inhibitor (PPI), such as lansoprazole, to reduce the amount of acid your stomach produces, you can take Gaviscon with it. But take these two medicines separately, leaving a gap of 2 hours between them.

How do I come off Gaviscon?

Usually you can stop taking Gaviscon without reducing the dose first.

If you’ve taken Gaviscon regularly for a long time, talk to your doctor before you stop taking it. Stopping suddenly may mean that the acid stomach contents come up into your food pipe and make your symptoms come back.

Are there other medicines similar to Gaviscon?

Yes, there are similar medicines to Gaviscon. Examples are Acidex (Calcium carbonate + Sodium alginate + Sodium bicarbonate) and Peptac (Calcium carbonate + Sodium alginate + Sodium bicarbonate).

Like Gaviscon, these medicines are reflux suppressants. They work in the same way as Gaviscon, to reduce acid in your stomach and prevent excess acid escaping into your food pipe. They generally work as well as Gaviscon and have similar side effects. However, they may be given in different doses to Gaviscon.

Sometimes, if Gaviscon doesn’t work or agree with you, your doctor or pharmacist may suggest another reflux suppressant. Like Gaviscon, you can buy Peptac or Acidex from pharmacies and supermarkets.

Is the Gaviscon I buy the same as on prescription?

Doctors can only prescribe some kinds of Gaviscon – not the full range available from pharmacies and supermarkets.

Different kinds of Gaviscon contain different ingredients. Speak to your doctor or pharmacist to make sure you get a medicine that suits you.

Can I drive or ride a bike?

Yes, taking Gaviscon shouldn’t affect your ability to drive or ride a bike.

Can lifestyle changes help with heartburn and indigestion?

Making a few changes to your diet and lifestyle may help if you have problems caused by too much stomach acid.

It can help if you:

• keep to a healthy weight or lose weight if you need to – extra weight can put pressure on your stomach and make acid reflux worse
• don’t eat foods that can make your symptoms worse, including rich, spicy and fatty foods, and acidic foods like tomatoes, citrus fruits, salad dressings and fizzy drinks
• cut down on caffeinated drinks, such as tea, coffee and cola, as well as alcohol and smoking
• try not to eat for at least 3 hours before you go to bed
• raise the head of your bed a little
• stop smoking

Who can and can’t take Gaviscon

Gaviscon can be taken by adults, including pregnant and breastfeeding women.

If your baby or child has problems with reflux or indigestion, talk to your doctor as soon as you can. Only treat them with Gaviscon if their doctor prescribes it.

• Never give Gaviscon to children under 12 years old, unless their doctor prescribes it.

To make sure a particular medicine is safe for you, tell your doctor or pharmacist if you have:

• had an allergic reaction to Gaviscon or any other medicines in the past
• been advised to eat a low calcium or low salt diet
• kidney or heart disease
• phenylketonuria (PKU) is a rare but potentially serious inherited disorder. People with Phenylketonuria (PKU) can’t break down the amino acid phenylalanine, which then builds up in the blood and brain. This can lead to brain damage.
• low levels of phosphate in your blood

Gaviscon in Pregnancy and Breastfeeding

Tell your doctor if you’re trying to get pregnant, are already pregnant or if you’re breastfeeding.

Usually Gaviscon is safe to take during pregnancy and while breastfeeding.

If you’re pregnant, it’s best to try to treat indigestion without taking a medicine. For example, it can help to:

• eat smaller meals more often
• avoid fatty or spicy foods
• raise the head of your bed a little

If this doesn’t work, your doctor or midwife may recommend a medicine like Gaviscon.

Gaviscon and Breastfeeding

Gaviscon is safe to take while you’re breastfeeding.

However, if your baby is premature or has health problems, check with your doctor first.

Cautions with other medicines

For safety, tell your doctor or pharmacist if you’re taking any other medicines, including herbal remedies, vitamins or supplements.

Some medicines must not be taken at the same time as Gaviscon. This is because the medicines can interfere with each other.

Don’t take Gaviscon within 2 hours before or after taking:

• antihistamines
• some antibiotics (quinolones and tetracyclines)
• iron tablets
• medicines to treat fungal infections
• beta-blockers (for heart problems)
• penicillamine (for rheumatoid arthritis)
• steroids (for inflammatory and autoimmune disorders)
• antipsychotic medicines (for mental health problems like bipolar disease and schizophrenia)
• chloroquine (for malaria)
• estramustine (for prostate cancer)
• bisphosphonates such as alendronic acid (to treat and prevent bone problems such as osteoporosis)
• levothyroxine
• a protein pump inhibitor (PPI) such as omeprazole and lansoprazole

It’s safe to take paracetamol at the same time as Gaviscon. Do not take other painkillers, like ibuprofen or aspirin, with Gaviscon without talking to your doctor or pharmacist first. These can make your symptoms worse.

Mixing Gaviscon with herbal remedies and supplements

There are no known problems with taking herbal remedies and supplements alongside Gaviscon.

Gaviscon vs Maalox

Maalox is a drug indicated for the treatment of heartburn (acid reflux) and indigestion. Maalox active ingredients (in each 5 mL teaspoon) are Aluminum hydroxide (equivalent to dried gel, USP) 200 mg + Magnesium hydroxide 200 mg + Simethicone 20 mg

Simethicone is used to treat the symptoms of gas such as uncomfortable or painful pressure, fullness, and bloating.

Simethicone allows gas bubbles in the stomach and intestines to come together more easily, which allows for easier passage of gas.

Simethicone is used to relieve painful pressure caused by excess gas in the stomach and intestines. Simethicone is for use in babies, children, and adults.

Maalox is used for the relief of:

• acid indigestion
• heartburn
• sour stomach
• upset stomach associated with these symptoms
• pressure and bloating commonly referred to as gas

Inactive ingredients: butylparaben, carboxymethylcellulose sodium, flavor, hypromellose, microcrystalline cellulose, propylparaben, purified water, saccharin sodium, simethicone emulsion, sorbitol

Other information

• each teaspoon contains: calcium 25 mg and magnesium 85 mg
• store at 20°-25°C (68°-77°F)
• does not meet USP requirements for preservative effectiveness

Maalox Directions of Use

• shake well before using
• Adults and children 12 years and older: take 2-4 tsp (10-20 mL) up to 4 times a day or as directed by a doctor
• Children under 12: ask a doctor

Maalox Warnings

Ask a doctor before use if you have:

• kidney disease
• a magnesium-restricted diet

Ask a doctor or pharmacist before use if you are:

• now taking a prescription drug. Antacids may interact with certain prescription drugs.

When using Maalox

• do not exceed 16 teaspoonsful (80 mL) in a 24-hour period or use the maximum dosage for more than 2 weeks unless directed by a doctor

Keep out of reach of children.

How and when to take Gaviscon

It’s usual to take Gaviscon up to 4 times a day. It’s best to take it after meals and at bedtime. This is usually when the pain and discomfort is worst. If your doctor has prescribed Gaviscon, take it when they tell you to.

You can get Gaviscon as tablets. You can also get it as a liquid in bottles or sachets.

It comes as a powder for babies and children under 2 years old. You mix the powder with cool boiled water or formula milk.

How much should I take?

The dose depends on the type of Gaviscon you’re taking. Follow the instructions on the packaging or, if your doctor has prescribed it, take the dose they tell you to.

How often should I have Gaviscon?

• If you get occasional mild heartburn or indigestion, only take Gaviscon when you need it.
• If you often have heartburn or indigestion, take Gaviscon regularly after meals and at bedtime – up to 4 times a day – whether or not you have symptoms.
• If you’ve been taking Gaviscon for more than 7 days and you’re still feeling uncomfortable or in pain, talk to your doctor.

How long will I take Gaviscon for?

Depending on the reason you’re taking Gaviscon, you may only need it when you have symptoms. Or you may need to take it for a few weeks or months – or for many years.

Talk to your doctor about what is best for you.

What if I forget to take Gaviscon?

If you usually take Gaviscon regularly but forget to take a dose, don’t double your dose the next time. Just leave out the missed dose and take your next dose as normal.

If you forget doses often, it may help to set an alarm to remind you. You could also ask your pharmacist for advice on other ways to help you remember to take your medicine.

What if I take too much?

Taking too much Gaviscon by accident may cause side effects such as wind and bloating (when your tummy feels tight and full of gas). This is unlikely to cause you any harm. If you are worried, talk to your doctor or pharmacist.

Gaviscon dosage

Gaviscon Liquids

Gaviscon Regular Strength Liquid active ingredients (in each 15 mL tablespoonful) are Aluminum hydroxide 95 mg + Magnesium carbonate 358mg

• Inactive ingredients (Regular Strength): benzyl alcohol, D&C yellow #10, edetate disodium, FD&C blue #1, flavor, glycerin, saccharin sodium, sodium alginate, sorbitol solution, water, xanthan gum
• Each tablespoon (15mL) contains: magnesium 115mg, sodium 52mg
• Store at up to 25°C (77°F); avoid freezing
• Keep tightly closed

Gaviscon Extra Strength Liquid active ingredients (in each 5 mL teaspoonful) are Aluminum hydroxide 254 mg + Magnesium carbonate 237.5mg

• Inactive ingredients (Extra Strength): benzyl alcohol, edetate disodium, flavor, glycerin, saccharin sodium, simethicone emulsion, sodium alginate, sorbitol solution, water, xanthan gum
• Each teaspoon (5mL) contains: magnesium 80mg, sodium 14mg
• Store at up to 25°C (77°F); avoid freezing
• Keep tightly closed

Gaviscon Liquids Directions of Use

• Shake well.
• Take after meals or at bedtime.
• Dispense product only by spoon or other measuring device provided.
• Take 1-2 tablespoons (15ml to 30ml) 4x a day for Regular Strength 
• OR
• 2-4 teaspoonfuls (10ml to 20ml) 4x a day for Extra Strength, or as directed by a doctor.

Gaviscon Liquid Warnings

• Do not use if you have kidney disease

Ask a doctor or pharmacist before use if you are:

• taking a prescription drug. Antacids may interact with certain prescription drugs.
• if you are on a sodium-restricted diet

When using this product (Regular Strength)

• do not take more than 8 tablespoonfuls in 24 hours
• do not use the maximum dosage for more than 2 weeks
• laxative effect may occur

When using this product (Extra Strength)

• do not take more than 16 teaspoonfuls in 24 hours
• do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor
• laxative effect may occur

Keep out of reach of children.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. This is a free and confidential service. All local poison control centers in the United States use this national number. You should call if you have any questions about poisoning or poison prevention. It does NOT need to be an emergency. You can call for any reason, 24 hours a day, 7 days a week.

Be ready to tell or show what was taken, how much, and when it happened.

Gaviscon Chewable Tablets

Gaviscon Regular Strength Chewable Tablet active ingredients (in each tablet) are dried Aluminum hydroxide gel 80mg + Magnesium trisilicate 14.2mg

• Inactive ingredients (Regular Strength): acesulfame k, alginic acid, artificial flavor, calcium stearate, corn starch, corn syrup solids, mannitol, sodium bicarbonate, stearic acid, sucrose
• Each tablet contains: magnesium 5mg, sodium 21 mg
• Store at up to 25°C (77°F) in a dry place

Gaviscon Extra Strength Chewable Tablet active ingredients (in each tablet) are Aluminum hydroxide 160 mg + Magnesium carbonate 105mg

• Inactive ingredients (Extra Strength): alginic acid, calcium stearate, flavor, sodium bicarbonate, and sucrose. May contain stearic acid. Contains sorbitol or mannitol. May contain starch.
• Each tablet contains: magnesium 35mg, sodium 20mg
• Store at up to 25°C (77°F) in a dry place

Gaviscon Chewable Tablets Directions of Use

• DO NOT SWALLOW WHOLE.
• Chew 2-4 tablets after meals and at bedtime as needed (up to 4x a day), or as directed by a doctor. For best results follow by a half glass of water or other liquid.
• Do not take more than 16 Regular Strength tablets in 24 hours.

Gaviscon Regular Strength Chewable Tablets Warnings

Do NOT use

• for peptic ulcers
• if you have trouble swallowing

Ask a doctor before use if you have:

• kidney disease
• a sodium restricted diet

Ask a doctor or pharmacist if you:

• are taking a prescription drug. Antacids may interact with certain prescription drugs.

Stop use and ask a doctor if:

• heartburn or stomach pain continues
• you need to take this product for more than 14 days

Keep out of reach of children.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. This is a free and confidential service. All local poison control centers in the United States use this national number. You should call if you have any questions about poisoning or poison prevention. It does NOT need to be an emergency. You can call for any reason, 24 hours a day, 7 days a week.

Be ready to tell or show what was taken, how much, and when it happened.

Gaviscon Extra Strength Chewable Tablets Warnings

Ask a doctor or pharmacist before use if you are:

• taking a prescription drug. Antacids may interact with certain prescription drugs.
• if you are on a sodium-restricted diet

When using this product:

• do not take more than 16 tablets in 24 hours
• do not use the maximum dosage for more than 2 weeks

Keep out of reach of children.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. This is a free and confidential service. All local poison control centers in the United States use this national number. You should call if you have any questions about poisoning or poison prevention. It does NOT need to be an emergency. You can call for any reason, 24 hours a day, 7 days a week.

Be ready to tell or show what was taken, how much, and when it happened.

Gaviscon side effects

Gaviscon is a very safe medicine. Most people who take it don’t have any side effects. If you do get a side effect, it’s likely to be mild and will go away when you stop taking Gaviscon.

Some types of Gaviscon may be more likely to make you feel sick or cause vomiting, constipation or diarrhea because of their ingredients. Talk to your doctor or pharmacist if you notice any side effects that bother you or don’t go away.

Serious allergic reaction

In very rare cases, it’s possible to have an allergic reaction to Gaviscon. This happens in less than 1 in 10,000 patients. If you have an allergic reaction stop taking Gaviscon and contact a doctor straight away.

• A serious allergic reaction is an emergency. Contact a doctor straight away if you think you or someone around you is having a serious allergic reaction.

The warning signs of a serious allergic reaction are:

• getting a skin rash that may include itchy, red, swollen, blistered or peeling skin
• wheezing
• tightness in the chest or throat
• having trouble breathing or talking
• swelling of the mouth, face, lips, tongue or throat

These are not all the side effects of Gaviscon. For a full list see the leaflet inside your medicines packet.