Երկիր: Ամերիկայի Միացյալ Նահանգներ
Լեզու: անգլերեն
Աղբյուրը: NLM (National Library of Medicine)
RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7)
REMEDYREPACK INC.
RANITIDINE HYDROCHLORIDE
RANITIDINE 150 mg
ORAL
PRESCRIPTION DRUG
Ranitidine tablets, USP is indicated in: - Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Trials 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. Trials 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 trials have been carried out for
Ranitidine tablets, USP 150 mg (ranitidine HCI USP equivalent to 150 mg of ranitidine) are brown coloured, circular shaped, biconvex, beveled edge film-coated tablets debossed with "S/429" on one side and plain on the other side. They are available in bottles of 60 (NDC 64380-803-03, 64380-936-03 ), 100 (NDC 64380-803-06, 64380-936-06), 500 (NDC 64380-803-07, 64380-936-07) and 1000 (NDC 64380-803-08, 64380-936-08) tablets. Ranitidine tablets, USP 300 mg (ranitidine HCI USP equivalent to 300 mg of ranitidine) are brown coloured, circular shaped, biconvex, beveled edge film-coated tablets debossed with "S/430" on one side and plain on the other side. They are available in bottles of 30 (NDC 64380-804-04, 64380-937-04), 100 (NDC 64380-804-06, 64380-937-06) and 250 (NDC 64380-804-38, 64380-937-38) tablets. Store at 20° to 25° C (68° and 77°F); excursions permitted between 15° and 30° C (59° and 86°F) [see USP Controlled Room Temperature]. Protect from light. Replace cap securely after each opening. Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816 Revised: 06/ 2019
Abbreviated New Drug Application
RANITIDINE IMMEDIATE RELEASE- RANITIDINE TABLET REMEDYREPACK INC. ---------- PRESCRIBING INFORMATION DESCRIPTION The active ingredient in ranitidine tablets, USP 150 mg and 300 mg is ranitidine hydrochloride (HCl), USP, 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, HCl. It has the following structure: The empirical formula is C H N O S.HCl, representing a molecular weight of 350.87 Ranitidine HCl USP is a white to pale yellow crystalline powder that is soluble in water. It has a slightly bitter taste and sulfur-like odor. Each ranitidine tablets, USP 150 mg for oral administration contains 168 mg of ranitidine HCl USP equivalent to 150 mg of ranitidine. Each tablet also contains the inactive ingredients magnesium stearate, microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, hypromellose, titanium dioxide, triacetin, and iron oxide red. Each ranitidine tablets, USP 300 mg for oral administration contains 336 mg of ranitidine HCl USP equivalent to 300 mg of ranitidine. Each tablet also contains the inactive ingredients magnesium stearate, microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, hypromellose, titanium dioxide, triacetin, and iron oxide red. 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 with an intravenous (IV) injection with mean peak levels of 440 to 545 ng/mL occurring 2 to 3 hours after a 150-mg dose. The syrup is bioequivalent to the tablets. 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 Կարդացեք ամբողջական փաստաթուղթը