MONISTAT 3 VAGINAL CREAM

Страна: Канада

Язык: английский

Источник: Health Canada

Активный ингредиент:

MICONAZOLE NITRATE

Доступна с:

INSIGHT PHARMACEUTICALS, LLC

код АТС:

G01AF04

ИНН (Международная Имя):

MICONAZOLE

дозировка:

4%

Фармацевтическая форма:

CREAM

состав:

MICONAZOLE NITRATE 4%

Администрация маршрут:

VAGINAL

Штук в упаковке:

3X5GM

Тип рецепта:

OTC

Терапевтические области:

AZOLES

Обзор продуктов:

Active ingredient group (AIG) number: 0110272004; AHFS:

Статус Авторизация:

APPROVED

Дата Авторизация:

2011-11-03

Характеристики продукта

PRODUCT MONOGRAPH
MONISTAT* 3 VAGINAL CREAM
MICONAZOLE NITRATE CREAM 4% (W/W) USP
Antifungal Agent
_ATC code: G01A F04_
Insight Pharmaceuticals Corp.
Langhorne, PA, U.S.A. 19047-1749
Date of Preparation:
November 24, 2011
_ _
Control#: 151101
_ _
*Trademark
2
PRODUCT MONOGRAPH
MONISTAT* 3 VAGINAL CREAM
MICONAZOLE NITRATE CREAM 4% (W/W) USP
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.
3
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.
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