FAMOCID Anti-Ulcerative     COMPOSITION Famocid 20 Each tablet contains 20 mg famotidine. Famocid 40 Each tablet contains 40 mg famotidine.     PROPERTIES - Famocid is a new, long acting histamine H2-receptor antagonist. - It plays a major role in the management of gastro-intestinal disorders by reducing gastric acid out-put as a result of H2-receptor blockade . Famocid competitively inhibits the action of Histamine at H2 receptors of the parietal cells and reduces basal, nocturnal, Pentagastrin and food-stimulated gastric acid production.     INDICATIONS - Active benign gastric ulceration. - Duodenal ulceration. - Reflux oesophagitis. - Pathological hypersecretory conditions such as Zollinger - Ellison Syndrome. - Prevention of the ulcer relapse.     DOSAGE AND ADMINISTRATION Active Benign Gastric Ulceration & Duodenal Ulceration : Initial dose is one 40 mg Famocid tablet daily taken at night "before bed time" for four to eight weeks . Maintenance dose is one 20mg Famocid tablet daily taken at night "before bed time" * To prevent the recurrence of duodenal ulceration a maintenance dose of 20 mg Famocid should be given. * If ulcer is clinically healed, treatment period can be shortened. Gastro-Oesophageal Reflux Disease : The recommended dose is 20 mg Famocid tablet by mouth twice daily for 6-12 weeks, where gastro-oesophageal reflux disease is associated with oesophageal ulceration the recommended dose is 40 mg Famocid tablet twice daily for six to twelve weeks. Zollinger - Ellison Syndrome : The Initial recommended dose is 20 mg Famocid tablet every six hours. Dosage should be adjusted to individual patient needs and should be continued for as long as prescribed clinically.     GENERAL INSTRUCTIONS FOR USE * The suitable dosing and duration of therapy will be prescribed by the physician. * Take the prescribed dose before bed time at night with half a cup of water. * Swallow the whole tablet. Do not chew the tablet. Use During Pregnancy & Breast- Feeding : There are inadequate information to estimate the potential hazard of this substance when used in Pregnancy. The amount of famotidine secreted in milk is too small to be harmful, thus Famotidine appears to be safe during lactation . However, do not use unless potential benefits outweighs risks.     CONTRAINDICATIONS Known Hypersensitivity to Famotidine.     PRECAUTIONS Renal Dysfunction : Caution should be exercised when giving famotidine to patients with renal dysfunction because famotidine is largely excreted by kidney. Liver Dysfunction : Dosage adjustment should not be imperative in patients with hepatic cirrhosis. However, dosage adjustment might be deemed necessary in patients with severe liver dysfunction. Gastric neoplasm : Since symptomatic response of gastric ulcer does not preclude the presence of gastric malignancy. Gastric malignancy should be excluded prior to starting of gastric ulcer treatment with famotidine since H2-receptor antagonists may mask the symptoms of gastric neoplasm. Paediatric use : Efficacy and safety of this product have not been established in this population of patients.     SIDE EFFECTS Adverse reactions are generally mild, rare side effects have been reported. Most frequent reported side effects include headache, dizziness, constipation and diarrhea, rarely toxic epidermal necrolysis, dry mouth, anxiety and urticaria. Reversible and transitional elevations of AST and ALT have been reported.     INTERACTIONS No clinically significant drug - drug interactions. Famotidine does not interfere with the hepatic cytochrome P450 enzyme complex. Therefore , it has no influence on Plasma levels of compounds metabolized by microsomal cytochrome P450 system including aminopyrine, antipyrine, diazepam, phenytion, theophyllin and warfarin. Famotidine is weakly bound to plasma protein; about 15% - 20%.     SPECIAL NOTES Compliance to diet and regular DIATAB intake are of utmost importance. Overdosage, interaction, or dietary errors may lead to hypoglycemic episodes (headache, irritability, restlessness, profuse sweating, insomnia, tremor, impairment of performance and alertness) which must be immediately reported to the physician. In this case the patient may not be fit to drive, to cross the road or to operate machinery. Sign of hypoglycemia can be corrected by administering carbohydrates (sugar in various forms). When situation of unusual stress arises ( e.g. emergency surgery & febrile infections) a temporary change to insulin may become necessary.     PRESENTATIONS Famocid is available in tablets of 20 mg and 40 mg Famotidine.