Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7)
American Health Packaging
RANITIDINE HYDROCHLORIDE
RANITIDINE 15 mg in 1 mL
ORAL
PRESCRIPTION DRUG
Ranitidine oral solution 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
Ranitidine Oral Solution, a clear, peppermint-flavored liquid, contains 16.8 mg of ranitidine HCl equivalent to 15 mg of ranitidine per 1 mL (75 mg/5 mL). 10 mL unit dose cups: 40 cups (4 x 10) NDC 60687-260-23 10 mL unit dose cups: 50 cups (5 x 10) NDC 60687-260-69 Store between 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Do not freeze. DO NOT USE IF SEAL IS BROKEN. PACKAGING INFORMATION American Health Packaging unit dose cups (see How Supplied section) contain drug product from Lannett Company as follows: (150 mg per 10 mL / 40 UD) NDC 60687-260-23 packaged from NDC 54838-550 (150 mg per 10 mL / 50 UD) NDC 60687-260-69 packaged from NDC 54838-550 Distributed by: American Health Packaging Columbus, OH 43217 8426069/1218F
Abbreviated New Drug Application
RANITIDINE- RANITIDINE HYDROCHLORIDE SOLUTION AMERICAN HEALTH PACKAGING ---------- RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP) RX ONLY 8426069/1218F DESCRIPTION The active ingredient in Ranitidine Syrup (Ranitidine Oral Solution, USP) 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 1 mL of Ranitidine Syrup (Ranitidine Oral Solution, USP) contains 16.8 mg of ranitidine HCl equivalent to 15 mg of ranitidine. Ranitidine Syrup (Ranitidine Oral Solution, USP) also contains the inactive ingredients acesulfame-K, dibasic sodium phosphate, glycerin, peppermint flavor, propylene glycol, propylparaben, purified water, methylparaben, monobasic sodium phosphate, sodium saccharin, and water (Purified). 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. The oral solution 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 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. _DISTRI Přečtěte si celý dokument