MICATIN MICONAZOLE NITRATE CREAM 2% USP

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

MICONAZOLE NITRATE

Available from:

WELLSPRING PHARMACEUTICAL CANADA CORP

ATC code:

D01AC02

INN (International Name):

MICONAZOLE

Dosage:

2%

Pharmaceutical form:

CREAM

Composition:

MICONAZOLE NITRATE 2%

Administration route:

TOPICAL

Units in package:

9G/30G

Prescription type:

OTC

Therapeutic area:

AZOLES

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2007-07-04

Summary of Product characteristics

PRODUCT MONOGRAPH
Micatin
®
miconazole nitrate cream 2% USP
Miconazole nitrate cream USP, 2%
Micatin
®
powder spray
–
unscented 2% Miconazole nitrate USP
aerosol, 2%
ANTIFUNGAL AGENT
WellSpring Pharmaceutical Canada Corp.
4 Innovation Drive
Dundas, Ontario
Canada L9H 7P3
Date of
Revision
May 12, 2020
Control
Nos. 235783 and 235806
PRODUCT MONOGRAPH
Micatin
®
miconazole nitrate cream 2% USP
Micatin
®
powder spray - unscented 2%
THERAPEUTIC CLASSIFICATION
Antifungal Agent
CLINICAL PHARMACOLOGY
Miconazole nitrate exhibits broad spectrum in vitro fungistatic
activity; for example,
against species of the genus Candida. Studies with Candida albicans
(strain R.V.
4688) indicate that at low concentrations, miconazole nitrate acts
primarily on the
yeast cell membrane resulting in selective inhibition of the uptake of
precursors of
RNA and DNA (purines) and mucopolysaccharide (glutamine).
In addition, in vitro antibacterial activity has been reported
(gram-positive baccilli and
cocci).
INDICATIONS AND CLINICAL USE
Micatin
®
is indicated for the topical treatment of dermatophytes and Candida
infections and also lesions caused by mixed infections involving
susceptible fungi. It
has been clinically effective in treating tinea pedis (athlete's
foot), tinea cruris (jock
itch), tinea corporis (ringworm), and tinea versicolor (fungal
infection of the skin) caused
by dermatophytes.
3
Micatin
®
is also effective in cutaneous candidiasis (skin infections caused by
candida
fungi), excluding moderate to severe
candidal paronychia (inflammation and infection of the
nail folds caused by candida fungi). Among the organisms against which
Micatin
®
has
been found effective are Trichophyton rubrum, Trichophyton
mentagrophytes, Trichophyton
interdigitale, Epidermophyton floccosum, Microsporum canis,
Microsporum gypseum,
species of Candida including C. Albicans, and Malassezia furfur.
CONTRAINDICATIONS
Ask a doctor or pharmacist before use if you are taking the
prescription blood thinning
medicine warfarin, because bleeding or bruisi