A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Abelcet Online, Description, Chemistry, Ingredients - Amphotericin B
Abelcet Online, Description, Chemistry, Ingredients - Amphotericin B
DESCRIPTION
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
|
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