מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
Ranitidine Hydrochloride (UNII: BK76465IHM) (Ranitidine - UNII:884KT10YB7)
Precision Dose Inc.
Ranitidine Hydrochloride
Ranitidine 15 mg in 1 mL
ORAL
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 carrie
Ranitidine Oral Solution USP, a clear peppermint flavored liquid, contains 16.8 mg of ranitidine HCl, USP equivalent to 15 mg of ranitidine per 1 mL (75 mg/5 mL). NDC 68094-204-61 10 mL per unit dose cup One hundred (100) cups per shipper NDC 68094-204-62 10 mL per unit dose cup Thirty (30) cups per shipper Store between 4° and 25°C (39° and 77°F). Dispense in tight, light-resistant containers as defined in the USP/NF. Do not freeze.
Abbreviated New Drug Application
RANITIDINE HYDROCHLORIDE- RANITIDINE HYDROCHLORIDE SOLUTION PRECISION DOSE INC. ---------- RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP) 150 MG/10 ML RX ONLY DESCRIPTION The active ingredient in 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, USP 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 Oral Solution, USP contains 16.8 mg of ranitidine HCl, USP equivalent to 15 mg of ranitidine. Ranitidine Oral Solution, USP also contains the inactive ingredients butylparaben, dibasic sodium phosphate, hypromellose, monobasic sodium phosphate, natural peppermint extract, propylene glycol, propylparaben, purified water, saccharin sodium, sodium chloride, and sorbitol solution. CLINICAL PHARMACOLOGY Ranitidine hydrochloride is a competitive, reversible inhibitor of the action of histamine at the histamine H -receptors, including receptors on the gastric cells. Ranitidine hydrochloride does not lower serum Ca in hypercalcemic states. Ranitidine hydrochloride is not an anticholinergic agent. PHARMACOKINETICS Absorption Ranitidine hydrochloride 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 absor קרא את המסמך השלם