Famotidine is indicated in:

• Gastric ulcer
• Duodenal ulcer
• Anastomotic ulcer
• Acute stress ulcer
• Reflux esophagitis
• Zollinger-Ellison syndrome

Famotidine is also indicated for the treatment of acute gastritis and chronic gastritis in the acute exacerbation stage.

Famotidine is a histamine H₂-receptor antagonist. Famotidine completely inhibits the action of histamine on H₂-receptors of parietal cells. It inhibits basal, overnight, and pentagastrin-stimulated gastric acid secretion. The H₂-receptor antagonist activity of Famotidine is slowly reversible, since the drug dissociates slowly from the H₂-receptor.

Tablet:

• For gastric ulcer, duodenal ulcer, anastomotic ulcer, upper gastrointestinal hemorrhage, reflux esophagitis, and Zollinger-Ellison syndrome: Usual dose for adults: Famotidine 20 mg twice daily (after breakfast and after supper or before bedtime) or Famotidine 40 mg can be administered orally once daily at bedtime.

• For the treatment of acute gastritis and chronic gastritis in the acute exacerbation stage: Usual dosage for adults is Famotidine 20 mg orally twice a day (after breakfast and after supper or before bedtime). Also, Famotidine 40 mg can be orally administered once a day (before bedtime); dosage should be adjusted according to age and symptoms. Most ulcer patients heal within 4-8 weeks. For maintenance therapy, the recommended oral dose is 20 mg once daily. Or, as directed by the registered physician.

Powder for Suspension:

Gastroesophageal Reflux Disease (GERD):

• <1 year of age: 0.5 mg/kg/dose of famotidine oral suspension up to 8 weeks once daily in patients

• Age 3 to 11 months: 0.5 mg/kg/dose twice daily up to 8 weeks

• Age 1 to 2 months: 0.5 mg/kg/dose once daily up to 8 weeks

• Neonates: 0.5 mg/kg/dose maximum once daily up to 8 weeks

Patients 1-16 years of age:

• Gastroesophageal Reflux Disease (GERD): 1 mg/kg/day orally divided twice daily up to 40 mg twice daily

• Duodenal ulcer: 0.5 mg/kg/day orally at bedtime or divided twice daily up to 40 mg/day

• Peptic ulcer: 0.5 mg/kg/day orally at bedtime or divided twice daily up to 40 mg/day

• Maintenance therapy: 40 mg at night daily

• Reflux esophagitis: 2 mg/kg/day

• Zollinger-Ellison Syndrome: 40 mg 3 times daily

No clinically important drug interactions have been identified. Famotidine does not interact with the cytochrome P450-linked drug-metabolizing enzyme system.

Known hypersensitivity to any component of the drug.

Eruption, constipation, diarrhea, dry mouth, nausea, vomiting, tachycardia, high blood pressure, headache, drowsiness, or insomnia may rarely occur.

Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. Caution should be exercised when Famotidine is administered to a nursing woman.

The drug should be used in the minimum required amount depending upon the conditions of the diseases. The drug should be administered carefully in elderly patients, patients with renal failure, and patients with hepatic disorders.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.