International generic name
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.
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.
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
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.
Supersensitivity; nausea; vomiting; diarrhea; constipation; elevation of transaminase
level; ebb; vertigo; headache; psychic disturbances; hyperexcitation.
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.
60 film-coated tablets of 150 mg. 30 film-coated tablets of 300 mg.