RANIDIL
Ranitidine Film Coated Tablet

PRESENTATION
Ranidil Tablet : Each film coated round tablet contains Ranitidine 150 mg as Ranitidine hydrocloride USP.

DESCRIPTION
The active ingredient of Ranidil 150 Tablet is Ranitidine Hydrochoride. Ranidil is a histamine H2 receptor antagonist. It inhibits basal and stimulated secretion of gastric acid. Ranidil is rapidly absorbed after oral administration. Food or antacid does not interfere its absorption.

INDICATION
Ranidil tablet is indicated for the treatment of duodenal ulcer, benign gastric ulcer, postoperative ulcer, reflux esophagitis, Zollinger-Ellison syndrome and in other conditions where reduction of gastric actidity is baneficial.

CLINICAL PHARMACOLOGY
Ranitidine is potent histamine H2 receptor antagonist and inhibits gastric acid secretion elicited by histamine. Ranitidine also inhibits acid secretion elicited by gastrin and, to a lesser extent, by muscarinic agonists. Ranitidine inhibits basal and nocturnal acid secretion and that stimulated by food, fundic distention, and various drugs, It reduces both the volume and acid concentration of gastric juice. The output of pepsin and secretion of intrinsic factor are reduce.

Ranitidine is readily absorbed from the gastrointestinal tract with pack concentrations in plasma occuring about 2 to 3 hours after oral administration. The bioavailability of ranitidine is about 50% due to first-pass metabolism. The elimination half-life from plasma is around 2 to 3 hours and ranitidine is weakly bound to plasma protein (about 15%). A small proportion of ranitidine is metabolized in the liver and is excreted unchanged in the urine. Ranitidine crosses the placental barrier and is excreted into breast milk.

DOSAGE AND ADMINISTRATION
--> Duodenal and Gastric ulcer: The usual dosage is 150 mg twice daily taken in the morning and evening or 300 mg as a single dose at night for 4 to 8 weeks.

--> Reflux esophagitis: 150 mg twice daily or 300 mg at bed time for up to 8 weeks.

--> Zollinger-Ellison syndrome: 150 mg 3 times daily, if necessary increased up to 6g daily in divided doses. Dosages should be continued as long as clinically indicated.

--> Episodic Dyspepsia: 150 mg twice daily for 6 weeks.

--> Maintenance theraphy: 150 mg at night for preventing ulcer recurrences.

SIDE EFFECTS
Ranitidine is well tolerated and side effects are usually uncommon. Altered bowel habit, dizziness, rash, tiredness, reversible confusional states, headache, decreased blood counts, muscle or join pain have rarely been reported.

PRECAUTIONS
Ranitidine should be given in reduced dosage to patients with impaired renal and hepatic function.

PREGNANCY
Ranitidine crosses the placenta. But there is no evidence of impaired fertility or harm to the fetus due to Ranitidine. Like other drugs, Ranitidine should only be used during pregnancy if considered essential.

NURSING MOTHERS
Ranitidine is excreted in human breast milk. Caution should be exercised when the drug is administered to a nursing mother.

PHARMACEUTICAL PRECAUTIONS
Store in a Cool and dry place. Protect from light.

PACKAGING
Ranidil Tablet : Box contains 100 Tablets in 10 x 10's Alu Alu foil pack.