FAMOTIDINE injection, solution

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Baxter Healthcare Corporation

INN (International Name):

FAMOTIDINE

Sammensætning:

FAMOTIDINE 20 mg in 50 mL

Indgivelsesvej:

INTRAVENOUS

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Famotidine Injection is supplied as a premixed solution in GALAXY plastic containers (PL 2501 Plastic) and 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 this product. 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.

Produkt oversigt:

FOR INTRAVENOUS USE ONLY Famotidine Injection containing 20 mg of famotidine per 50 mL is a clear, non-preserved, sterile solution premixed in a vehicle made iso-osmotic with sodium chloride. Famotidine Injection is supplied in a carton of 12 x 50 mL single dose GALAXY plastic containers as follows: 2G3424 50 mL container NDC 0338-5197-41 Store Famotidine Injection in GALAXY containers (PL 2501 Plastic) at room temperature (25°C/77°F). Exposure of the premixed product to excessive heat should be avoided. Brief exposure to temperatures up to 35°C (95°F) does not adversely affect the product.

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

FAMOTIDINE- FAMOTIDINE INJECTION, SOLUTION
BAXTER HEALTHCARE CORPORATION
----------
FAMOTIDINE INJECTION
IN GALAXY PLASTIC CONTAINER (PL 2501)
RX ONLY
DESCRIPTION
The active ingredient in Famotidine Injection 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 337.45. 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 is supplied as a sterile solution, for
intravenous use only, in plastic single dose
GALAXY containers. Each 50 mL of the premixed, iso-osmotic intravenous
injection contains 20 mg
Famotidine, USP, and the following inactive ingredients: L-aspartic
acid 6.8 mg, sodium chloride, USP,
450 mg, and Water for Injection. The pH ranges from 5.7 to 6.4 and may
have been adjusted with
additional L-aspartic acid and/or with sodium hydroxide.
The GALAXY plastic container is fabricated from a specially designed
multilayer plastic (PL 2501).
Solutions are in contact with the polyethylene layer of the container
and can leach out certain chemical
components of the plastic in very small amounts within the expiration
period. The suitability and safety
of the plastic have been confirmed in tests in animals according to
the USP biological tests for plastic
containers, as well as by tissue culture toxicity studies.
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 n