국가: 캐나다
언어: 영어
출처: Health Canada
FLUCONAZOLE
NU-PHARM INC
J02AC01
FLUCONAZOLE
150MG
CAPSULE
FLUCONAZOLE 150MG
ORAL
100
OTC
AZOLES
Active ingredient group (AIG) number: 0122529004; AHFS:
CANCELLED (UNRETURNED ANNUAL)
2018-03-28
PRODUCT MONOGRAPH NU-FLUCONAZOLE-150 (FLUCONAZOLE) CAPSULES, 150 MG ANTIFUNGAL AGENT NU-PHARM INC. DATE OF PREPARATION: 50 MURAL STREET, UNITS 1 & 2 OCTOBER 20, 2009 RICHMOND HILL, ONTARIO L4B 1E4 CONTROL#: 133358 - 1 - PRODUCT MONOGRAPH NAME OF DRUG NU-FLUCONAZOLE-150 (Fluconazole) Capsules, 150 mg THERAPEUTIC CLASSIFICATION Antifungal Agent ACTIONS AND CLINICAL PHARMACOLOGY Fluconazole is a highly selective inhibitor of fungal cytochrome P-450 sterol C-14-_alpha_- demethylation. Mammalian cell demethylation is much less sensitive to fluconazole inhibition. The subsequent loss of normal sterols correlates with the accumulation of 14-_alpha_-methyl sterols in fungi and may be responsible for the fungistatic activity of fluconazole. A standard, randomized, two-way crossover, single-dose bioavailability study was conducted in twenty (20) healthy, adult, male volunteers to evaluate the relative bioavailability of single oral doses (1 H 150 mg) of NU-FLUCONAZOLE-150 Capsules manufactured by Apotex Inc. and Diflucan 150® Capsules manufactured by Pfizer Canada Inc. The mean pharmacokinetic parameters of the 17 subjects completing the study are listed in the following table: - 2 - SUMMARY TABLE OF THE COMPARATIVE BIOAVAILABILITY DATA FLUCONAZOLE (DOSE: 150 MG) FROM MEASURED DATA GEOMETRIC MEAN ARITHMETIC MEAN (CV%) PARAMETER NU-FLUCONAZOLE-150 DIFLUCAN 150®† RATIO O F GEOMETRIC MEANS AUC 0-72h ( F g A hr/mL) 87.2 89.9 (20.4) 89.6 92.3 (20.8) 97.3 AUC I ( F g A hr/mL) 141.9 147.3 (21.5) 140.8 144.8 (21.8) 100.8 C max ( F g/mL) 2.26 2.29 (19.1) 2.76 2.76 (15.4) 81.8 T max (h)* 5.33 (60.4) 1.67 (45.1) -- t ½ (h)* 44.6 (27.4) 42.1 (21.8) -- *Arithmetic means only (CV%). †Diflucan 150® is manufactured by Pfizer Canada Inc. and was purchased in Canada. INDICATIONS AND CLINICAL USE Fluconazole capsules are indicated for the oral treatment of: • Vaginal candidiasis (yeast infections due to _Candida_). The diagnosis of vaginal candidiasis should be confirmed by KOH smears and/or cultures before initiating therapy with 전체 문서 읽기