FAMOTIDINE- famotidine injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8)

Available from:

Fresenius Kabi USA, LLC

INN (International Name):

FAMOTIDINE

Composition:

FAMOTIDINE 10 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 eff

Product summary:

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. PREMIERProRx® is a registered trademark of Premier Healthcare Alliance, L.P., used under license. Manufactured by: Fresenius Kabi Lake Zurich, IL 60047 www.fresenius-kabi.com/us 451450B Revised: June 2021

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FAMOTIDINE - FAMOTIDINE INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
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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