Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7)
Lake Erie Medical DBA Quality Care Products LLC
RANITIDINE HYDROCHLORIDE
RANITIDINE 150 mg
ORAL
PRESCRIPTION DRUG
Ranitidine Tablets, USP is indicated in: 1. 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. 2. 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. 3. The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis). 4. 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. 5. Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled studies have been carried
Ranitidine Tablets, USP 150 mg are orange, round, biconvex aqueous film coated tablets debossed “IP 253” on one side and plain on the reverse. They are available in bottles of 24, 60, 100, 180, 500 and 1000. Ranitidine Tablets, USP 300 mg are yellow, capsule-shaped aqueous film coated tablets debossed “IP 254” on one side and plain on the reverse. They are available in bottles of 24, 30, 100, 250, 500 and 1000. Store at 20° - 25°C (68° - 77°F) (See USP Controlled Room Temperature) in a tight, light resistant container. Protect from light. Replace cap securely after each opening.
Abbreviated New Drug Application
RANITIDINE- RANITIDINE TABLET LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC ---------- RANITIDINE TABLETS, USP RX ONLY DESCRIPTION The active ingredient in Ranitidine Tablets, USP 150 mg and Ranitidine Tablets, USP 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 is a white to pale yellow, granular substance that is soluble in water. It has a slightly bitter taste and sulfurlike odor. Each Ranitidine Tablets, USP 150 mg for oral administration contains 167.4 mg of ranitidine HCl equivalent to 150 mg of ranitidine. Each tablet also contains the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, titanium dioxide, triethyl citrate and FD&C Yellow #6. Each Ranitidine Tablets, USP 300 mg for oral administration contains 334.8 mg of ranitidine HCl equivalent to 300 mg of ranitidine. Each tablet also contains the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, titanium dioxide, triethyl citrate and D&C Yellow #10. CLINICAL PHARMACOLOGY Ranitidine Tablets, USP is a competitive, reversible inhibitor of the action of histamine at the histamine H -receptors, including receptors on the gastric cells. Ranitidine Tablets, USP does not lower serum Ca in hypercalcemic states. Ranitidine Tablets, USP is not an anticholinergic agent. PHARMACOKINETICS: _ABSORPTION:_ Ranitidine Tablets, USP 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 sli Прочитайте повний документ