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Fungizone

Drug Description
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Fungizone IV
(amphotericin B) for Injection

WARNING

This drug should be used primarily for treatment of patients with progressive and potentially life-threatening fungal infections; it should be not be used to treat noninvasive forms of fungal disease such as oral thrush, vaginal candidiasis and esophageal candidiasis in patients with normal neutrophil counts.

DRUG DESCRIPTION

FUNGIZONE intravenous (Amphotericin B for Injection) contains amphotericin B, an antifungal polyene antibiotic obtained from a strain of Streptomyces nodosus. Amphotericin B is designated chemically as [1R-( 1R*, 3S*, 5R*, 6R*, 9R*, 11R*, 15S*, 16R*, 17R*, 18S*, 19E, 21E, 23E, 25E, 27E, 29E, 31E, 33R*, 35S *, 36R*, 7S*)]-33-[(3-Amino-3,6-dideoxy-ß-D- mannopyranosyl)-oxy],3,5,6,9,11,17,37-octahydroxy-15,16,18-trimethyl 13-oxo-14,39- dioxabicyclo[ 33.3.1] nonatriaconta-19,21,23,25,27,29,31-heptaene-36-carboxylic acid.

The chemical formula is C47H73NO17 and the molecular weight is 924.09 Each vial contains a sterile, nonpyrogenic, lyophilized cake (which may partially reduce to powder following manufacture) providing 50 mg amphotericin B and 41 mg sodium desoxycholate with 20.2 mg sodium phosphates as a buffer. Crystalline amphotericin B is insoluble in water; therefore, the antibiotic is solubilized by the addition of sodium desoxycholate to form a mixture which provides a colloidal dispersion for intravenous infusion following reconstitution.

At the time of manufacture the air in the vial is replaced by nitrogen.

Brand Name: Fungizone
Generic Name: Amphotericin B

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