Ranitidine

Ranitidine Tablets are indicated in: Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Studies available to date have not assessed the safety of Ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. No placebo – controlled comparative studies have been carried out for periods longer than 1 year. The treatment of pathological hypersecretory conditions. (e.g., Zollinger-Ellison syndrome and systemic mastocytosis). Short-term treatment of active, benign gastric ulcers. Most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated. Studies available to date have not assessed the safety of ranitidine in uncomplicated, benign gastric ulcer for periods of more than 6 weeks.

Active Duodenal Ulcer: The current recommended adult oral dosage of Ranitidine Tablets for duodenal ulcer is 150 mg twice daily. An alternative dosage of 300 mg once daily after the evening meal or at bedtime can be used for patients in whom dosing convenience is important. The advantages of one treatment regimen compared with the other in a particular patient population have yet to be demonstrated. Smaller doses have been shown to be equally effective in inhibiting gastric acid secretion in US studies, and several foreign trials have shown that 100 mg twice daily is as effective as the 150 mg dose. Antacid should be given as needed for relief of pain. Maintenance of Healing of Duodenal Ulcers: The current recommended adult oral dosage is 150 mg at bedtime.

Ranitidine Tablets are contraindicated for patients known to have hypersensitivity to the drug or any of the ingredients.

General: Symptomatic response to therapy with Ranitidine Tablets does not preclude the presence of gastric malignancy. Since Ranitidine Tablets are excreted primarily by the kidney, dosage should be adjusted in patients with impaired renal function. Caution should be observed in patients with hepatic dysfunction since Ranitidine Tablets are metabolized in the liver. Rare reports suggest that Ranitidine Tablets may precipitate acute porphyric attacks in patients with acute porphyria. Ranitidine Tablets should therefore be avoided in patients with a history of acute porphyria. This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons.

The following have been reported as events in clinical trials or in the routine management of patients treated with Ranitidine Tablets. The relationship to therapy with Ranitidine Tablets has been unclear in many cases. Headache, sometimes severe, seems to be related to administration of Ranitidine Tablets. Central Nervous System: Rarely, malaise, dizziness, somnolence, insomnia and vertigo. Rare cases of reversible mental confusion, agitation, depression, and hallucinations have been reported, predominantly in severely ill elderly patients. Rare cases of reversible blurred vision suggestive of a change in accommodation have been reported. Rare reports of reversible involuntary motor disturbances have been received. Cardiovascular: As with other H 2 -blockers, rare reports of arrhythmias such as tachycardia, bradycardia, atrioventricular block, and premature ventricular beats.

Store at 15ºC to 30ºC (59ºF to 86ºF) in a dry place. Note to the Pharmacist: Inform the patient after first opening, store the tablets in the original bottle for up to 3 months (90 days). Protect from light. ​​​​​​​ * MULTISTIX is a registered trademark of Bayer Healthcare LLC.