Држава: Сједињене Америчке Државе
Језик: Енглески
Извор: NLM (National Library of Medicine)
RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7)
Aurobindo Pharma Limited
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 Syrup (Ranitidine Oral Solution, USP), a clear, colorless to pale yellow, peppermint-flavored liquid, contains 16.8 mg of ranitidine hydrochloride equivalent to 15 mg of ranitidine per mL (75 mg/5 mL). Bottle of 474 mL NDC 65862-431-74 Store at 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. Dispense in tight, light-resistant containers as defined in the USP/NF. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad–500 038, India Revised: 03/2019
Abbreviated New Drug Application
RANITIDINE - RANITIDINE HYDROCHLORIDE SYRUP AUROBINDO PHARMA LIMITED ---------- RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP) RX ONLY 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 molecular formula is C H N O S•HCl, representing a molecular weight of 350.87. Ranitidine hydrochloride, USP is a white to pale yellow, crystalline, practically odorless powder. It is sensitive to light and moisture. Each mL of ranitidine oral solution contains 16.8 mg of ranitidine hydrochloride equivalent to 15 mg of ranitidine. Ranitidine oral solution also contains the inactive ingredients alcohol (7.5%), butyl paraben, dibasic sodium phosphate anhydrous, hypromellose, monobasic potassium phosphate, natural peppermint flavor, propyl paraben, purified water, saccharin sodium, sodium chloride, and sorbitol solution. 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 formulation 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 2 13 22 4 3 2 ++ high-potency antacid (150 mmol) in fasting subjects has been reported to decrease the absorption of ranitidine. _DISTRIBUTION_ The vo Прочитајте комплетан документ