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MYCOSPOR®Cream
MYCOSPOR® Solution
SCHEDULING STATUS:
S2
PROPRIETARY NAME
(and dosage form):
MYCOSPOR
®
Cream
MYCOSPOR
®
Solution
COMPOSITION:
CREAM:
Bifonazole
10 mg
Benzyl Alcohol (as preservative) 1% m/m
Inert cream base o/w to 1 g.
SOLUTION: Bifonazole 10 mg
Inert solvent to 1 mL.
PHARMACOLOGICAL CLASSIFICATION:
A.13.9.2. Fungicides
PHARMACOLOGICAL ACTION:
Bifonazole is a broad-spectrum antifungal, which suppresses cell wall synthesis.
Its in vitro activity against dermatophytes (e.g. Trichophyton spp.) is primarily fungicidal whereas that against yeasts is
primarily fungistatic.
INDICATIONS:
Indicated in mycoses of the skin and mucocutaneous parts due to dermatophytes,Candida species, Malassezia furfur,
Corynebacterium minutissimum and Aspergillus species.
CONTRA-INDICATIONS:
Hypersensitivity to bifonazole and cetyl stearyl alcohol (cream).
WARNINGS:
In the first 3 months of pregnancy MYCOSPOR should not be used without first consulting a doctor.
Solution is inflammable. Keep away from open flame.
For external use only.
DOSAGE AND DIRECTIONS FOR USE:
MYCOSPOR Cream or Solution is used once daily, preferably before retiring. It is applied thinly to the affected skin
areas, and rubbed in. Usually only a few drops (about 3 drops) of solution or when using the pump spray, 1 or 2
depressions of the spray head, or a small amount (approximately ½ cm) of cream, will suffice for the treatment of an area
the size of the palm of the hand.
For hygienic support of treatment it is advisable to wash and thoroughly dry the skin areas affected before applying
MYCOSPOR Cream or Solution.
Treatment with MYCOSPOR Cream or Solution should not be stopped when the acute inflammatory symptoms and signs
have subsided, but depending on the disease being treated, be continued for 2 to 4 weeks.
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