International generic name

Ranitidine

Drug form and composition

Film-coated tablets. One film-coated tablet contains 168 mg or 336 mg Ranitidine hydrochloride, equivalent to 150 mg or 300 mg Ranitidine.

Indications

Ranitidine is indicated in: duodenal ulcer; stomach ulcer; prophylaxis and treatment of elevated acidity of stomach; treatment of gastroesophageal reflux; treatment of Zollinger-Ellison syndrome; treatment of elevated stomach hypersecretion in endocrine multiplen adenoma, etc.

Dosage and administration

Adults: duodenal ulcer - for treatment it is applied orally, 150 mg twice daily or 300 mg once in the evening before sleeping with a therapeutic course of 4 to 8 weeks; for prophylaxis of recurrences, orally 150 mg before sleeping; stomach ulcer - for treatment it is applied orally, 150 mg twice daily with a therapeutic course of 4 to 8 weeks; in elevated stomach acidity - 75 mg applied orally and the dose may be repeated after 24 hours; Zollinger-Ellison syndrome and endocrine multiplen adenoma - applied orally, 150-300 mg twice daily. The dose may be increased depending on the severity of the case and the treatment should continue till coping with the clinical symptoms (doses higher than 6 g daily should be used in rare cases). Gastroesophageal reflux - for treatment it is applied orally, 150 mg twice daily in a course of 8 weeks. In erosive gastritis the recommended daily dose is 150 mg four times daily. In children over 8 years old: duodenal and stomach ulcer - applied orally in a dose of 2-4 mg/kg body weight twice daily in a therapeutic course not longer than 6 to 8 weeks, and the maximal 24-hours dose should not exceed 300 mg daily; gastroesophageal reflux - applied orally in a dose of 2-8 mg/kg body weight three times daily. The therapeutic course in the treatment of this disease may be longer than 8 weeks. In severe renal insufficiency is recommended a single dose of 150 mg in the evening for a period of 4 to 8 weeks.

Contraindications

It is not administered in supersensitivity to the preparation, severe liver and renal injuries, immunosuppressed patients.

Special warnings and precautions

Prior to beginning of therapy with Ranitidin it is necessary to exclude the possibility of existing malignant stomach disease as the preparation may mask its symptoms. As Ranitidin is excreted via the kidneys, it should be dosed accurately to patients with renal diseases. It is recommended a regular control of patients, treated with non-steroid anti-inflammatory medicines and Ranitidin. The administration of Ranitidin should be avoided in patients with acute porphyria as it may provoke quicker development of acute porphyric attack. Up to 30% of preparation’s effect is lost when administered simultaneously with antiacid medicines as a result of reduction of its resorption. Therefore it is recommended to administer Ranitidin at least one hour before them. The preparation is applied during pregnancy and lactation only after a strict precision of indications.


Drug interactions

Ranitidin is a weak inhibitor of liver medicine metabolism. The simultaneous administration of Rantidin with oral anticoagulants, phenytoin, benzodiazepines, beta-blockers and theophyllin inhibits their elimination. During the simultaneous administration of Rantidin with anticoagulants should be controlled the prothrombin time and if possible to monitor plasma concentrations of the latter, in order to avoid eventual bleeding. Ranitidin inhibits the resorption of ketoconazole and antiacids, containing aluminium and magnesium. The simultaneous administration of Ranitidin with procainamide may reduce its excretion via the kidneys and as a result to increase the plasma concentration of procainamide.

Adverse reactions

Supersensitivity; nausea; vomiting; diarrhea; constipation; elevation of transaminase level; ebb; vertigo; headache; psychic disturbances; hyperexcitation.

Pharmacological mechanisms

Ranitidin as a selective blocker of H2-histamine receptors, located in the parietal cells of basolateral membrane, exerts its effect by reduction of basal, night and food stimulated stomach secretion. It inhibits the secretory effect if histamine, insulin, pentagastrine, acetylcholine and coffeine. It does not change the secretion of the intrinsic-factor, serum gastrine and exocrine pancreas secretion. It does not change the vascularity of stomach mucosa and the evacuation of stomach content. It does not affect the lower esophageal sphincter. Cytoprotective affect is presumed, due to the increased endogenic synthesis of PGE2 and PGF2 and the reduction of leukotrienes, which participate in maintenance of local inflammatory process. The trophic effect of Rantidin is proved on mucus production cells as well as increased regenerative ability on epithelial cells in the ulcer edge.

Supplied

60 film-coated tablets of 150 mg. 30 film-coated tablets of 300 mg.

Expiry

2 years.