Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
RANITIDINE (UNII: 884KT10YB7) (RANITIDINE - UNII:884KT10YB7)
Sandoz Inc.
RANITIDINE
RANITIDINE 15 mg in 1 mL
TOPICAL
PRESCRIPTION DRUG
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-controlled studies have been carri
Ranitidine Oral Solution, USP, is a clear, pale yellow, peppermint-flavored liquid. Each mL contains 16.8 mg of ranitidine hydrochloride equivalent to 15 mg of ranitidine supplied in bottles of 16 fluid ounces (one pint) (NDC 0781-6087-16). Store between 4° and 25°C (39° and 77°F) [see USP Controlled Room Temperature]. Do not freeze. Dispense in tight, light-resistant containers as defined in the USP/NF. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Manufactured by TOLMAR Inc. Fort Collins, CO 80526 for Sandoz Inc. Princeton, NJ 08540 44431 Rev. 0 10/10 MULTISTIX is a registered trademark of Bayer Healthcare LLC.
Abbreviated New Drug Application
RANITIDINE - RANITIDINE SYRUP SANDOZ INC. ---------- RANITIDINE ORAL SOLUTION, USP 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 mL of ranitidine oral solution, USP contains 16.8 mg of ranitidine HCl equivalent to 15 mg of ranitidine. Ranitidine oral solution, USP also contains the inactive ingredients alcohol, butylparaben, dibasic sodium phosphate heptahydrate, hypromellose, peppermint flavor, monobasic potassium phosphate, propylparaben, purified water, saccharin sodium, sodium chloride, and sorbitol. CLINICAL PHARMACOLOGY Ranitidine oral solution, USP is a competitive, reversible inhibitor of the action of histamine at the histamine H -receptors, including receptors on the gastric cells. Ranitidine oral solution, USP does not lower serum Ca++ in hypercalcemic states. Ranitidine oral solution, USP is not an anticholinergic agent. _PHARMACOKINETICS_ _ABSORPTION: _Ranitidine oral solution, 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. 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 high-potency antacid (150 mmol) in fasting subjects has been reported to decrease the absorption of ranitidine oral solution, USP. _DISTRIBUTIO Baca dokumen lengkapnya