Country: United States
Language: English
Source: NLM (National Library of Medicine)
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8)
Fresenius Kabi USA, LLC
FAMOTIDINE
FAMOTIDINE 10 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
Famotidine Injection, supplied as a concentrated solution for intravenous injection, is intended for intravenous use only. Famotidine Injection 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: - 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 8 weeks. - 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. - Short term treatment of active benign gastric ulcer. Most adult patients heal within 6 weeks. Studies have not assessed the safety or efficacy
FOR INTRAVENOUS USE ONLY Famotidine Injection, USP 10 mg per mL is a non-preserved, clear, colorless solution and is supplied as: Store Famotidine Injection at 2° to 8°C (36° to 46°F). If solution freezes, bring to room temperature; allow sufficient time to solubilize all the components Although diluted Famotidine Injection 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 should be refrigerated and used within 48 hours (see DOSAGE AND ADMINISTRATION ). This container closure is not made with natural rubber latex. www.fresenius-kabi.com/us 45884G Revised: April 2021
Abbreviated New Drug Application
FAMOTIDINE - FAMOTIDINE INJECTION, SOLUTION FRESENIUS KABI USA, LLC ---------- FAMOTIDINE INJECTION, USP Rx only DESCRIPTION The active ingredient in Famotidine Injection, USP is a histamine H –receptor antagonist. Famotidine is [1-Amino-3-[[[2- [(diaminomethylene)amino]-4- thiazolyl]methyl]thio]propylidene] sulfamide. 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, Water for Injection q.s. 1 mL. 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 evening oral doses of 20 and 40 mg inhibited basal and nocturnal acid secretion in 2 2 all subjects; mean nocturnal gastric acid secretion was inhibited by 86% and 94%, r Read the complete document