FAMOTIDINE injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Institutional 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: Hypersensitivity to any component of these products. Cross sensitivity in this class of compounds has been observed. Therefore, Famotidine Injection should not be administered to patients with a history of hypersensitivity to other H2 -receptor antagonists.

Product summary:

FOR INTRAVENOUS USE ONLY Famotidine Injection, USP 10 mg/mL, is a non-preserved, clear, colorless solution and is available in the following: NDC 67457-433-22 25 x 2 mL single-dose vials Famotidine injection, USP 10 mg/mL, is a clear, colorless solution and is available in the following: NDC 67457-448-43 10 x 4 mL multi-dose vials NDC 67457-457-20 10 x 20 mL multi-dose vials Storage 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 ). Manufactured for: Mylan Institutional LLC Rockford, IL 61103 U.S.A. Manufactured by: Mylan Laboratories Limited Bangalore, India AUGUST 2020

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FAMOTIDINE- FAMOTIDINE INJECTION
MYLAN INSTITUTIONAL 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,
USP 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, USP is a white to pale yellowish white crystalline powder
compound that is freely soluble
in dimethylformamide and glacial acetic acid, slightly soluble in
methanol, very slightly soluble in
water, and practically insoluble in acetone, in alcohol, in
chloroform, in ether and in ethyl acetate.
Famotidine Injection, USP is supplied as a sterile concentrated
solution for intravenous injection. Each
mL of the single dose solution contains 10 mg of famotidine, USP 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
perio