Negara: Kanada
Bahasa: Inggris
Sumber: Health Canada
CLOTRIMAZOLE
PRESTIGE PHARMA INC
G01AF02
CLOTRIMAZOLE
2%
CREAM
CLOTRIMAZOLE 2%
VAGINAL
25G
OTC
AZOLES
Active ingredient group (AIG) number: 0110231003; AHFS:
APPROVED
2012-10-26
1 PRODUCT MONOGRAPH NEO-ZOL VAGINAL CREAM 1% CLOTRIMAZOLE VAGINAL CREAM USP 1% NEO-ZOL VAGINAL CREAM 2% CLOTRIMAZOLE VAGINAL CREAM USP 2% ANTIFUNGAL AGENT PRESTIGE PHARMA INC. DATE OF PREPARATION: 6565 DUNCAN STREET NOVEMBER 13 , 2015 MONTREAL, QUEBEC H4B 1#8 CONTROL #187895 2 PRODUCT MONOGRAPH NEO-ZOL VAGINAL CREAM 1% Clotrimazole Vaginal Cream USP 1% NEO-ZOL VAGINAL CREAM 2% Clotrimazole Vaginal Cream USP 2% THERAPEUTIC CLASSIFICATION Antifungal Agent ACTION Clotrimazole acts primarily by damaging the permeability barrier in the cell membrane of fungi. Clotrimazole brings about inhibition of ergosterol biosynthesis, an essential constituent of fungal cell membranes. If ergosterol synthesis is completely or partially inhibited, the cell is no longer able to construct an intact cell membrane. This leads to death of the fungus. Exposure of Candida albicans to clotrimazole causes leakage of intracellular phosphorus compounds into the ambient medium with a concomitant breakdown of cellular nucleic acids and potassium eflux. The onset of these events is rapid and extensive after exposure of the organism to the drug, and causes a time-dependent and concentration- dependent inhibition of fungal growth. INDICATIONS Neo-Zol Vaginal Cream 1% is indicated for the 6-day treatment of vaginal candidiasis and associated vulval candidiasis. Neo-Zol Vaginal Cream 2% is indicated for the 3-day treatment of vaginal candidiasis and associated vulval candidiasis. CONTRAINDICATIONS Neo-Zol Vaginal Cream is contraindicated in patients who are hypersensitive to clotrimazole or any nonmedicinal ingredients in the formulation of Neo-Zol vaginal cream. For a complete listing, see the Composition section of the product monograph. 3 PRECAUTIONS Neo-Zol Vaginal Cream is not for ophthalmic use. Neo-Zol Vaginal Cream is not for oral use. As with all topical agents, skin sensitization may result. Use of Neo-Zol topical preparations should be discontinued should such reactions occur, and appropriate therapy instituted. Treatment during the menst Baca dokumen lengkapnya