SQUARE PHARMACEUTICALS LTD.
Famotidine is indicated for- Short term treatment of active duodenal ulcer and benign gastric ulcer Maintenance therapy for prevention of relapses of duodenal ulceration Gastro-oesophageal reflux disease Zollinger Ellison Syndrome
H2 receptor antagonist
Famotidine is a histamine H2-receptor antagonist. Famotidine completely inhibits the action of histamine on H2-receptors of parietal cell. 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 H2-receptor.
Duodenal ulcer: 40 mg at night for 4 to 8 weeks Benign gastric ulcer: 40 mg at night for 4 to 8 weeks; Maintenance therapy: 20 mg at night for preventing the recurrences of duodenal ulceration Gastro-oesophageal reflux disease: 20 mg twice daily for 6 to 12 weeks Zollinger Ellison syndrome: The recommended starting dose is 20 mg every six hours. Dosage should then be adjusted to individual response. Doses up to 160 mg every six hours have been administered to some patients without the development of significant adverse effects Dosage can be administered irrespective of meals. Antacids may be given concomitantly if needed.
Famotidine does not interact with the cytochrome P450 linked drug metabolising enzyme system. So, no interactions have been found in man with Warfarin, Theophylline, Phenytoin, Diazepam, Propranolol, Aminopyrine or antipyrine.
There are no known contraindication to Famotidine. If any evidence of hypersensitivity appear, the therapy should be discontinued and consultation with physician is required.
Famotidine is generally well tolerated and side effects are uncommon. Dizziness, headache, constipation and diarrhoea have been reported rarely. Other side effects reported less frequently include dry mouth, nausea and/or vomiting, rash, abdominal discomfort, anorexia and fatigue.
Pregnancy: There are no adequate, well controlled studies on Famotidine in pregnancy, but it is known to cross the placenta and should be prescribed only if clearly needed. Lactation: It is not known whether Famotidine is secreted into human milk, nursing mothers should either stop nursing or stop taking the drug.
Dosage reduction should be considered or interval between doses should be prolonged if creatinine clearance falls to or below 30 ml/min.
Tablet: Store between 15-308 C. Concentrate for injection: Store between 2-88 C.