FAMOTIDINE injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Hikma Pharmaceuticals USA Inc.

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 eight 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 of famotidine in uncomplicated active benign gastric ulcer for periods of more than 8 weeks. - Short term treatment of gastroesophageal reflux disease (GERD) . Famotidine is indicated for short term treatment of patients with symptoms of GERD (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies ). Famotidine is also indicated for the short term treatment of esophagitis due to GERD including erosive or ulcerative disease diagnosed by endoscopy (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies ). - Treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison Syndrome, multiple endocrine adenomas) (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies ). 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 available in the following:     Containing no preservative         2 mL (20 mg) Single Dose Vial packaged in 25s (NDC 0641-6022-25)     Containing benzyl alcohol as preservative         4 mL (40 mg) Two Dose Vial packaged in 10s (NDC 0641-6023-10)         20 mL Multiple Dose Vial packaged in 10s (NDC 0641-6021-10) Store Famotidine Injection at 2°C to 8°C (36°F 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 ).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FAMOTIDINE- FAMOTIDINE INJECTION
HIKMA PHARMACEUTICALS USA INC.
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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:
C H
N O S MW 337.45
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 is supplied as a sterile concentrated solution
for intravenous
injection. Each mL of the single dose 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 multiple dose vials of 4 mL and 20 mL also
contain 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 mg and 40 mg was 10 to 12
hours.
After intravenous administration, the maximum effect was achieved
within 30 minutes.
2
8
15
7
2 3
2
Single intravenous doses of 10 mg 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 mg an