Abelcet
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Abelcet
ABELCET®
(amphotericin B lipid complex) Injection
DRUG DESCRIPTION
ABELCET® (amphotericin b) 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-α-dimyristoylphosphatidylcholine (DMPC) and L-α-dimyristoylphosphatidylglycerol (DMPG), are present in a 7:3 molar ratio. ABELCET® (amphotericin b) 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-β-D-mannopyranosyl) oxy]-1,3,5,6,9,11,17,37-octahydroxy-15,16,18-trimethyl-13-oxo-14,39-dioxabicy-clo[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. The structural formula is:
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ABELCET® (amphotericin b) is provided as a sterile, opaque suspension in 20 mL glass, single-use vials. Each 20 mL vial contains 100 mg of amphotericin B (see DOSAGE AND ADMINISTRATION), and each mL of ABELCET® contains:
Amphotericin B USP.......................................5 mgL-α-dimyristoylphosphatidylcholine
(DMPC).......................................3.4 mg
L-α-dimyristoylphosphatidylglycerol (DMPG).......................................1.5
mg
Sodium Chloride USP.......................................9 mg
Water for Injection USP, q.s. 1 mL
What are the precautions when taking amphotericin b injection (Abelcet)?
Before using amphotericin/lipid complex, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: white blood cell (leukocyte) transfusions, heart disease (e.g., irregular heartbeat, congestive heart failure), liver disease, kidney disease.
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
It is unknown if this drug passes into breast milk. Consult your doctor before...
Last reviewed on RxList: 4/2/2009
This monograph has been modified to include the generic and brand name in many instances.
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