ABELCET® is a sterile, pyrogen-free suspension for intravenous infusion. ABELCET® consists of amphotericin B complexed with two phospholipids in a 1:1 drug-to-lipid molar ratio. The two phospholipids, L-a-dimyristoylphosphatidylcholine (DMPC) and L-a-dimyristoylphosphatidylglycerol (DMPG), are present in a 7:3 molar ratio. ABELCET® is yellow and opaque in appearance, with a pH of 5 - 7.
NOTE: Liposomal encapsulation or incorporation in a lipid complex can substantially affect a drug’s functional properties relative to those of the unencapsulated or nonlipid-associated drug. In addition, different liposomal or lipid- complexed 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 functional properties of these drug products.
Amphotericin B is a polyene, antifungal antibiotic produced 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*,37S*)]-33-[(3-Amino-3, 6-dideoxy-b-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.
It has a molecular weight of 924.09 and a molecular formula of C47H73NO17.
ABELCET® is provided as a sterile, opaque suspension in 20 mL glass, single-use vials. Each vial of ABELCET® contains 100 mg of amphotericin B (see DOSAGE AND ADMINISTRATION), and each mL of ABELCET® contains:
Amphotericin B USP
5 mg
L-a-dimyristoylphosphatidylcholine (DMPC)
3.4 mg
L-a-dimyristoylphosphatidylglycerol (DMPG)
1.5 mg
Sodium Chloride USP
9 mg
Water for Injection USP, q. s.
1 mL
