MICOZOLE CREAM

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

MICONAZOLE NITRATE

Disponible desde:

TARO PHARMACEUTICALS INC

Código ATC:

G01AF04

Designación común internacional (DCI):

MICONAZOLE

Dosis:

2%

formulario farmacéutico:

CREAM

Composición:

MICONAZOLE NITRATE 2%

Vía de administración:

VAGINAL

Unidades en paquete:

45G

tipo de receta:

OTC

Área terapéutica:

AZOLES

Resumen del producto:

Active ingredient group (AIG) number: 0110272001; AHFS:

Estado de Autorización:

CANCELLED POST MARKET

Fecha de autorización:

2023-08-09

Ficha técnica

PRODUCT MONOGRAPH
MICOZOLE
(MICONAZOLE NITRATE USP)
VAGINAL CREAM 2%
ANTIFUNGAL AGENT
Taro Pharmaceuticals Inc.
Date of Revision:
130 East Drive
August 11, 2015
Brampton, ON
L6T 1C1
Control #: 185852
Page 2 of 26
NAME OF DRUG
MICOZOLE
(Miconazole Nitrate USP)
Vaginal Cream 2%
THERAPEUTIC CLASSIFICATION
Antifungal Agent
CLINICAL PHARMACOLOGY
Depending upon concentration, miconazole nitrate exhibits
broad-spectrum in vitro fungistatic
or fungicidal activity against species of the genus Candida.
Miconazole nitrate also inhibits
several other genera of fungi, including dermatophytes and yeasts, as
well as gram positive
bacteria.
Miconazole nitrate inhibits the biosynthesis of ergosterol or other
sterols, damaging the fungal
cell wall membrane and altering its permeability. In fungi, it also
inhibits biosynthesis of
triglycerides and phospholipids as well as oxidative and peroxidative
enzymes. The latter
action results in intracellular buildup of toxic concentrations of
hydrogen peroxide, which may
contribute to deterioration of subcellular organelles and cellular
necrosis.
Candida albicans cells have been observed to exhibit progressive
cytoplasmic deterioration and
prominent shape changes resulting in complete cell necrosis depending
on the dose and
duration of exposure to miconazole nitrate. The sequence of
morphologic alterations induced
by miconazole nitrate at fungistatic doses (10
-6
M) are lysis of cytoplasmic organelles, focal to
complete loss of cell plasmalemma and irregular thickening of the cell
wall containing multiple
inclusions.
Administration of fungicidal doses (10
-4
M) induces a completely necrotic cell interior with an
unaltered cell wall.
Page 3 of 26
In Candida albicans, miconazole nitrate inhibits the transformation of
blastospores into
invasive mycelial form. Not all species or strains of a particular
organism may be susceptible
to miconazole nitrate.
To date, no wild strains or fungal mutants with substantial acquired
resistance to miconazole
have been reported; however, miconazole resistant