Maalox H2 Acid Controller (Famotidine)

MAALOX H2 ACID CONTROLLER™

Novartis Consumer Health

Famotidine

Histamine H2 Receptor Antagonist

Action And Clinical Pharmacology: Famotidine is a competitive inhibitor of histamine H2-receptors. The primary clinically important pharmacologic activity of famotidine is inhibition of gastric juice secretion. Famotidine reduces the acid and pepsin content, as well as the volume, of basal, nocturnal, and stimulated gastric secretion.

Indications And Clinical Uses: In the treatment of the following conditions where a controlled reduction of gastric secretion is required, such as acid indigestion, heartburn, sour or upset stomach. It is also indicated for the prevention of these symptoms when associated with the consumption of food and/or beverage.

Contra-Indications: Hypersensitivity to any component of this medication.

Precautions: General: In clinical trials, patients with other underlying acid gastrointestinal diseases (e.g., duodenal ulcer, gastric ulcer) did not experience complications; in general, they did not exhibit a clinically significant deterioration in their condition. However, if patients have difficulty swallowing or if abdominal discomfort persists, the underlying cause should be determined. Symptomatic response to therapy with famotidine does not preclude the presence of gastric malignancy.

Patients with severe kidney disease, previous history of ulcer disease complications, severe coexisting illness, those who are experiencing unintended weight loss in association with dyspeptic symptoms, and those who are middle-aged or older with new or recently changed dyspeptic symptoms should consult a physician before commencing therapy with famotidine.

Patients consuming nonsteroidal anti-inflammatory drugs may have dyspepsia as a side effect of these medicines and should consult a physician or a pharmacist before taking famotidine.

Therapy should not exceed 2 weeks of continuous treatment without medical consultation.

Drug Interactions: Studies with famotidine in man, in animal models, and in vitro have shown no significant interference with the disposition of compounds metabolized by the hepatic microsomal enzymes, e.g., cytochrome P450 system. Compounds tested in man have included warfarin, theophylline, phenytoin, diazepam, aminopyrine and antipyrine. lndocyanine green as an index of hepatic blood flow and/or hepatic drug extraction has been tested and no significant effects have been found.

Concomitant use of aluminum hydroxide/magnesium hydroxide at commonly used doses, does not influence the pharmacodynamics or bioavailability of famotidine. Famotidine does not affect gastric alcohol dehydrogenase and, consequently, blood ethanol levels.

Pregnancy: Reproductive studies have been performed in rats and rabbits at oral doses of up to 2 000 and 500 mg/kg/day, respectively (approximately 2 500 and 625 times the maximum recommended prescription human dose [80 mg], respectively), and have revealed no evidence of impaired fertility or harm to the fetus due to famotidine. There are, however, no adequate or well-controlled studies in pregnant women.

Since the safe use of famotidine in pregnant women has not been established, pregnant women should not use famotidine unless directed otherwise by a physician.

Lactation : Famotidine is detectable in human milk. Nursing mothers should either stop this drug or should stop nursing.

Children: Safety and effectiveness in children have not been established. Famotidine should not be administered to children under 12 years of age.

Geriatrics: No dosage adjustment is required based on age.

Adverse Reactions: Famotidine has been demonstrated to be generally well tolerated. Adverse reactions reported in ³1% of patients were headache and dizziness. These occurred with comparable frequency in patients treated with placebo.

Laboratory parameters may be affected during treatment with famotidine, but the changes are usually not considered serious. Among the laboratory changes that were reported during clinical trials were increases in AST, ALT, and WBC count, and decreases in hemoglobin and hematocrit. These changes were rarely of clinical significance.

No famotidine-treated patients/subjects had to be discontinued from therapy because of laboratory adverse experiences.

During marketed use of prescription doses, which are higher than those recommended for nonprescription use, the following adverse reactions have been reported; urticaria, liver enzymes abnormalities, cholestatic jaundice, anaphylaxis and angioedema. Toxic epidermal necrolysis has been reported very rarely with H2-receptor antagonists.

The following adverse reactions have been reported; however, a causal relationship to therapy with famotidine has not been established: agitation, confusion, hallucinations, grand mal seizures, rare cases of impotence, thrombocytopenia, pancytopenia, leukopenia and agranulocytosis.

Gynecomastia has been reported rarely. In most cases that were followed up, it was reversible after discontinuing treatment.

Symptoms And Treatment Of Overdose: Symptoms and Treatment: There is no experience to date with deliberate overdosage. Doses of up to 800 mg/day have been employed in patients with pathological hypersecretory conditions with no serious adverse effects. In the event of overdosage, treatment should be symptomatic and supportive. Unabsorbed material should be removed from the gastrointestinal tract, the patient should be monitored, and supportive therapy should be employed.

The oral LD50 of famotidine in male and female rats and mice was >5 000 mg/kg.

Dosage And Administration: Adults and children 12 years of age or older: 10 mg, as required to relieve symptoms. For prevention of acid-related symptoms associated with the consumption of food and/or beverage: 10 mg 1 hour before eating. Repeat if symptoms return, up to a maximum of 20 mg in a 24-hour period.

Therapy should not exceed 2 weeks of continuous treatment without medical consultation.

Concomitant Use with Antacids: Antacids may be given concomitantly if needed.

Availability And Storage: Each light yellow, round, biconvex, film-coated tablet engraved ”10″ on one side, contains: famotidine 10 mg. Nonmedicinal ingredients: carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dextrates, hydroxypropyl methylcellulose, magnesium stearate, polyethylene glycol, titanium dioxide and yellow ferric oxide. Unit dose packages of 2, 6, 12 and 30. Store at room temperature (15 to 30°C). Protect from light and moisture.

MAALOX H2 ACID CONTROLLER™ Novartis Consumer Health Famotidine Histamine H2 Receptor Antagonist

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