MONISTAT 7 VAGINAL CREAM

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

MICONAZOLE NITRATE

Available from:

INSIGHT PHARMACEUTICALS, LLC

ATC code:

G01AF04

INN (International Name):

MICONAZOLE

Dosage:

2%

Pharmaceutical form:

CREAM

Composition:

MICONAZOLE NITRATE 2%

Administration route:

VAGINAL

Units in package:

7X5G

Prescription type:

OTC

Therapeutic area:

AZOLES

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2011-11-03

Summary of Product characteristics

PRODUCT MONOGRAPH
MONISTAT* 7 VAGINAL CREAM
MICONAZOLE NITRATE 2%
MONISTAT* 3 VAGINAL OVULES
MICONAZOLE NITRATE 400 MG
MONISTAT* 7 DUAL-PAK*
MICONAZOLE NITRATE 100 MG SUPPOSITORIES + 2% CREAM
MONISTAT* 3 DUAL-PAK*
MICONAZOLE NITRATE 400 MG OVULES + 2% CREAM
Antifungal Agent
_ATC code: _G01A F04
_ _
Insight Pharmaceuticals Corp.
Langhorne, PA, U.S.A. 19047-1749
Date of Preparation:
November 24, 2011
Control #: 151075
*Trademark © 1994
_ _
PRODUCT MONOGRAPH
MONISTAT* 7 VAGINAL CREAM
MICONAZOLE NITRATE 2%
MONISTAT* 3 VAGINAL OVULES
MICONAZOLE NITRATE 400 MG
MONISTAT* 7 DUAL-PAK*
MICONAZOLE NITRATE 100 MG SUPPOSITORIES + 2% CREAM
MONISTAT* 3 DUAL-PAK*
MICONAZOLE NITRATE 400 MG OVULES + 2% CREAM
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 com