国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7)
PD-Rx Pharmaceuticals, Inc.
RANITIDINE HYDROCHLORIDE
RANITIDINE 300 mg
ORAL
PRESCRIPTION DRUG
Ranitidine Tablets USP 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 of 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 ulcer. 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. - Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled studies have been carried out
Ranitidine Tablets USP, 300 mg are available as beige, unscored, oval, film-coated tablets debossed 4358” on one side and “300” on the other side containing 300 mg ranitidine as ranitidine hydrochloride packaged in bottles of 14, 30 and 60 tablets. PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) in a dry place [See USP Controlled Room Temperature]. PROTECT FROM LIGHT Replace cap securely after each opening. RANITIDINE TABLETS USP
Abbreviated New Drug Application
RANITIDINE- RANITIDINE TABLET, FILM COATED PD-RX PHARMACEUTICALS, INC. ---------- RANITIDINE TABLETS USP DESCRIPTION Ranitidine hydrochloride USP is a histamine H -receptor antagonist. Chemically it is N[2-[[[5- [(dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-N´-methyl-2-nitro-1,1-ethenediamine, hydrochloride. Ranitidine HCl is a white to pale yellow, granular substance that is soluble in water. It has a slightly bitter taste and sulfur-like odor. The structural formula is: C H N O S•HCl M.W. 350.87 Each tablet, for oral administration, contains 168 mg or 336 mg of ranitidine HCl equivalent to 150 mg or 300 mg of ranitidine, respectively. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, red iron oxide, titanium dioxide, triethyl citrate and yellow iron oxide. CLINICAL PHARMACOLOGY Ranitidine is a competitive, reversible inhibitor of the action of histamine at the histamine H - receptors, including receptors on the gastric cells. Ranitidine does not lower serum Ca in hypercalcemic states. Ranitidine is not an anticholinergic agent. PHARMACOKINETICS Absorption Ranitidine is 50% absorbed after oral administration, compared to an intravenous (IV) injection with mean peak levels of 440 to 545 ng/mL occurring 2 to 3 hours after a 150 mg dose. Absorption is not significantly impaired by the administration of food or antacids. Propantheline slightly delays and increases peak blood levels of ranitidine, probably by delaying gastric emptying and transit time. In one study, simultaneous administration of high-potency antacid (150 mmol) in fasting subjects has been reported to decrease the absorption of ranitidine. Distribution The volume of distribution is about 1.4 L/kg. Serum protein binding averages 15%. Metabolism In humans, the N-oxide is the principal metabolite in the urine; however, this amounts to <4% of the 2 13 22 4 3 2 ++ dose. Other metabolites are the S-oxide (1%) and the desme 完全なドキュメントを読む