Amphotericin B cholesteryl sulfate description
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ahmed Zaghw, M.D. [2]
Description
AMPHOTEC® is a sterile, pyrogen-free, lyophilized powder for reconstitution and intravenous (IV) administration. AMPHOTEC consists of a 1:1 (molar ratio) complex of amphotericin B and cholesteryl sulfate. Upon reconstitution, AMPHOTEC forms a colloidal dispersion of microscopic disc-shaped particles.
Note: Liposomal encapsulation or incorporation into a lipid complex can substantially affect a drug’s functional properties relative to those of the unencapsulated drug or non-lipid associated drug. In addition, different liposomal or lipid-complex products with a common active ingredient may vary from one another in the chemical composition and physical form of the lipid component. Such differences may affect the functional properties of these drug products.
Amphotericin B is an antifungal polyene antibiotic produced by a strain of Streptomyces nodosus.
Amphotericin B, which is the established name for [1R (1R*,3S*,5R*,6R*,9R*,11R*, 15S*,16R*,17R*,18S*,19E,21E,23E,25E,27E,29E,31E,33R*,35S*,36R*,37S*)]-33-[(3-Amino-3,6-dideoxy-ß-D-mannopyranosyl)oxy]-1,3,5,6,9,11,17,37-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, has the following structure:
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The molecular formula of the drug is C47H73NO17; its molecular weight is 924.10.
AMPHOTEC is available in 50 mg and 100 mg single dose vials. Each 50 mg single dose vial contains amphotericin B, 50 mg; sodium cholesteryl sulfate, 26.4 mg; tromethamine, 5.64 mg; disodium edetate dihydrate, 0.372 mg; lactose monohydrate, 950 mg; and hydrochloric acid, qs, as a sterile, nonpyrogenic, lyophilized powder. Each 100 mg single dose vial contains amphotericin B, 100 mg; sodium cholesteryl sulfate, 52.8 mg; tromethamine, 11.28 mg; disodium edetate dihydrate, 0.744 mg; lactose monohydrate, 1900 mg; and hydrochloric acid, qs, as a sterile, nonpyrogenic, lyophilized powder.[1]
References
Adapted from the FDA Package Insert.