Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8)
Medical Purchasing Solutions, LLC
INTRAVENOUS
PRESCRIPTION DRUG
Famotidine injection, USP supplied as a concentrated solution for intravenous injection, is intended for intravenous use only. Famotidine injection, USP is indicated in some hospitalized patients with pathological hypersecretory conditions or intractable ulcers, or as an alternative to the oral dosage forms for short term use in patients who are unable to take oral medication for the following conditions: 1. Short term treatment of active duodenal ulcer. Most adult patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. Studies have not assessed the safety of famotidine in uncomplicated active duodenal ulcer for periods of more than eight weeks. 2. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of an active ulcer. Controlled studies in adults have not extended beyond one year. 3. Short term treatment of active benign gastric ulcer. Most adult patients heal within 6 weeks. Stud
FOR INTRAVENOUS USE ONLY Famotidine injection, USP 10 mg per 1 mL, is a non-preserved, clear, colorless solution and is supplied as follows: NDC 67457-433-22 25 x 2 mL single-dose vials. Famotidine injection, USP 10 mg per 1 mL, is a clear, colorless solution and is supplied as follows: NDC 67457-448-43 10 x 4 mL multi-dose vials NDC 67457-457-20 10 x 20 mL multi-dose vials Store famotidine injection, USP at 2° to 8°C (36° to 46°F). If solution freezes, bring to room temperature; allow sufficient time to solubilize all the components. Protect from light. Retain in carton until time of use. Although diluted famotidine injection, USP has been shown to be physically and chemically stable for 7 days at room temperature, there are no data on the maintenance of sterility after dilution. Therefore, it is recommended that if not used immediately after preparation, diluted solutions of famotidine injection, USP should be refrigerated and used within 48 hours (see DOSAGE AND ADMINISTRATION ). Mylan Institutional LLC Rockford, IL 61103 U.S.A. Manufactured by: Mylan Laboratories Limited Bangalore, India JULY 2016
Abbreviated New Drug Application
FAMOTIDINE- FAMOTIDINE INJECTION MEDICAL PURCHASING SOLUTIONS, LLC ---------- FAMOTIDINE INJECTION, USP RX ONLY DESCRIPTION The active ingredient in famotidine injection, USP is a histamine H -receptor antagonist. Famotidine is _N’_-(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4- thiazolyl]methyl]thio]propanimidamide. The empirical formula of famotidine is C H N O S and its molecular weight is 337.43. Its structural formula is: Famotidine is a white to pale yellow crystalline compound that is freely soluble in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in ethanol. Famotidine injection, USP is supplied as a sterile concentrated solution for intravenous injection. Each mL of the solution contains 10 mg of famotidine and the following inactive ingredients: L-aspartic acid 4 mg, mannitol 20 mg, and Water for Injection q.s. 1 mL. The multidose injection also contains benzyl alcohol 0.9% added as preservative. CLINICAL PHARMACOLOGY IN ADULTS GI EFFECTS Famotidine is a competitive inhibitor of histamine H -receptors. The primary clinically important pharmacologic activity of famotidine is inhibition of gastric secretion. Both the acid concentration and volume of gastric secretion are suppressed by famotidine, while changes in pepsin secretion are proportional to volume output. In normal volunteers and hypersecretors, famotidine inhibited basal and nocturnal gastric secretion, as well as secretion stimulated by food and pentagastrin. After oral administration, the onset of the antisecretory effect occurred within one hour; the maximum effect was dose dependent, occurring within one to three hours. Duration of inhibition of secretion by doses of 20 and 40 mg was 10 to 12 hours. After intravenous administration, the maximum effect was achieved within 30 minutes. Single intravenous doses of 10 and 20 mg inhibited nocturnal secretion for a period of 10 to 12 hours. The 20 mg dose was associated with the longest duration of action in most subjects. Single Prečítajte si celý dokument