देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
RANITIDINE (UNII: 884KT10YB7) (RANITIDINE - UNII:884KT10YB7)
RedPharm Drug, Inc.
ORAL
PRESCRIPTION DRUG
Ranitidine Syrup (Ranitidine Oral Solution USP) 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-control
Ranitidine Syrup (Ranitidine Oral Solution USP), a clear, pale yellow, spearmint-flavored liquid, contains 16.8 mg of ranitidine hydrochloride equivalent to 15 mg of ranitidine per 1 mL of oral solution (75 mg/5 mL) in bottles of 16 fl oz (NDC 0121-0727-16) and 10 mL unit dose cups, packaged in trays of 10 (NDC 0121-4727-10). Store at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Do not freeze. Dispense in tight, light-resistant containers as defined in the USP/NF.
Abbreviated New Drug Application
RANITIDINE- RANITIDINE SYRUP REDPHARM DRUG, INC. ---------- RANITIDINE SOLN SPL UNCLASSIFIED SECTION Rx ONLY DESCRIPTION The active ingredient in Ranitidine Syrup (Ranitidine Oral Solution USP) is ranitidine hydrochloride (HCl) USP, a histamine H2-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: [Chemical Structure] The empirical formula is C13H22N4O3S•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 hydrochloride equivalent to 15 mg of ranitidine. Ranitidine Syrup (Ranitidine Oral Solution USP) also contains the inactive ingredients dibasic sodium phosphate, hydroxyethylcellulose, methylparaben, purified water, sodium chloride, sodium saccharin, spearmint flavor, sucrose and may contain monobasic sodium phosphate. CLINICAL PHARMACOLOGY Ranitidine is a competitive, reversible inhibitor of the action of histamine at the histamine H2-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. Distribution The volume of distribution is about पूरा दस्तावेज़ पढ़ें