AMPHOTEC 100 MG POWDER FOR SUSPENSION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

AMPHOTERICIN B

Available from:

THREE RIVERS PHARMACEUTICALS LLC

ATC code:

J02AA01

INN (International Name):

AMPHOTERICIN B

Dosage:

100MG

Pharmaceutical form:

POWDER FOR SUSPENSION

Composition:

AMPHOTERICIN B 100MG

Administration route:

INTRAVENOUS

Units in package:

6X100MG- DILUTION 20ML

Prescription type:

Prescription

Therapeutic area:

POLYENES

Product summary:

Active ingredient group (AIG) number: 0105864003; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2013-08-22

Summary of Product characteristics

PRODUCT MONOGRAPH
AMPHOTEC
®
(Amphotericin B Cholesteryl Sulfate Complex for Injectable Suspension)
50 mg and 100 mg Amphotericin B per vial
THERAPEUTIC CLASSIFICATION
Antifungal Agent
Three Rivers Pharmaceuticals, LLC
Date of Preparation:
312 Commerce Park Drive
January 12, 2006
Cranberry Township, PA 16066
Distributed in Canada by:
Not currently distributed in Canada
Control # 103270
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PRODUCT MONOGRAPH
AMPHOTEC
®
(Amphotericin B Cholesteryl Sulfate Complex for Injectable Suspension)
50 mg and 100 mg Amphotericin B per vial
THERAPEUTIC CLASSIFICATION
Antifungal Agent
ACTION and CLINICAL PHARMACOLOGY
The active ingredient of AMPHOTEC
®
, amphotericin B, is a polyene antibiotic that acts by binding
to sterols (primarily ergosterol) in cell membranes of sensitive
fungi, with subsequent leakage of
intracellular contents and cell death due to changes in membrane
permeability. Amphotericin B also
binds to the sterols (primarily cholesterol) in mammalian cell
membranes, which is believed to
account for its toxicity in animals and humans.
AMPHOTEC
®
(Amphotericin B Cholesteryl Sulfate Complex for Injectable Suspension)
is a unique
formulation and 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.
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Note: The liposomal encapsulation or incorporation into a lipid
complex can substantially
affect a drug’s functional properties relative to those of
non-encapsulated drug or non-lipid
associated drug. Although the various liposomal and lipid-complexed
products all contain
amphotericin B, they differ significantly in their chemical
composition, stability, and physical
form of the lipid component and resultant pharmacokinetic profiles of
amphotericin B.
Pharmacokinetics (see PHARMACOLOGY-Pharmacokinetics)
The pharmacokinetics of amphotericin B administered as AMPHOTEC
®
are best described by an
open, two-compartment structural model with non-linear elimination.
For AMPHOTEC