Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7)
Keltman Pharmaceuticals Inc.
RANITIDINE HYDROCHLORIDE
RANITIDINE HYDROCHLORIDE 150 mg
ORAL
PRESCRIPTION DRUG
Ranitidine is 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 for 1 year. -
Ranitidine Tablets, USP for oral administration, are available as: 150 mg: round, off-white, unscored tablets, film-coated pink, debossed GG 705 on one side and plain on the reverse side. 300 mg: round, off-white, unscored tablets, film-coated orange, debossed GG 706 on one side and plain on the reverse side. Ranitidine Capsules, for oral administration, are available as: 150 mg: Opaque caramel capsules, imprinted GG 614 in white ink, filled with off-white powder. 300 mg: Opaque caramel capsules, imprinted GG 615 in white ink, filled with off-white powder. They are supplied by Keltman Pharmaceuticals Inc. as follows: Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature) in a dry place. Protect from light. Replace cap securely after each opening. Dispense in a tight, light-resistant container.
Abbreviated New Drug Application
RANITIDINE HYDROCHLORIDE - RANITIDINE HYDROCHLORIDE TABLET, FILM COATED KELTMAN PHARMACEUTICALS INC. ---------- RANITIDINE TABLETS, USP AND RANITIDINE CAPSULES DESCRIPTION Ranitidine hydrochloride (HCl), 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, 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 is a white to pale yellow, granular substance that is soluble in water. It has a slightly bitter taste and sulfur like odor. Each tablet, for oral administration contains 168 mg or 336 mg of ranitidine hydrochloride equivalent to 150 mg and 300 mg of ranitidine, respectively. Inactive ingredients: D & C Red #30 Aluminum Lake, hydroxypropyl cellulose, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, triethyl citrate, sodium starch glycolate, titanium dioxide and flavoring. The 300 MG also contains: D & C Yellow #10 Aluminum Lake. Each capsule, for oral administration contains 168 mg or 336 mg of ranitidine hydrochloride equivalent to 150 mg and 300 mg of ranitidine, respectively. Inactive ingredients: Ammonium hydroxide, colloidal silicon dioxide, corn starch, FD & C Blue #1, FD & C Red #40, FD & C Yellow #6, gelatin, magnesium stearate, pharmaceutical glaze, propylene glycol, silicon dioxide, simethicone, sodium lauryl sulfate, sodium starch glycolate, and titanium dioxide. 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 a anticholinergic agent. PHARMACOKINETICS ABS ORPTION Ranitidine tablets and ranitidine capsules are 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. Ab Prečítajte si celý dokument