FAMOTIDINE injection

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Medical Purchasing Solutions, LLC

Antoreitti:

INTRAVENOUS

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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

Tuoteyhteenveto:

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

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

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