Drug products: Diflucan, Diflucan®, Fluconazol Actavis, Fluconazol Aurobindo, Fluconazol Bluefish, Fluconazol Copyfarm, Fluconazol Fresenius Kabi, Fluconazol Hexal, Fluconazol HEXAL, Fluconazol Krka, Fluconazol Pharmathen, Fluconazol Takeda, Fluconazol Villerton, Fluconazole Abacus Medicine, Fluconazole Accord, Fluconazole B. Braun, Fluconazole Baxter, Flukonazol 2care4, Flukonazol Ebb, Flukonazol Medartuum, Flukonazol Mylan, Solona
ATC code: J02AC01
Controlled studies on differences between men and women regarding fluconazole efficacy in adults are lacking.
The present evidence concerning differences between men and women is limited and do not motivate differentiation in dosing or treatment.
A pharmacokinetic study in healthy volunteers (26 men, 33 women) receiving an oral dose of fluconazole 100 mg showed that women had 36% higher Cmax, 17% lower volume of distribution and 20% shorter half-life than men, after adjusting for total bodyweight. The authors suggest that the observed differences in volume of distribution are likely because of differences in total body water, which generally is higher in men . Similar results were observed in a study in Chinese volunteers (5 men, 5 women) receiving fluconazole 200 mg single dose . A study in HIV-positive patients (93 men, 29 women) observed no effect on patient’s sex on fluconazole pharmacokinetics .
Fluconazole efficacy was compared with nystatin in a randomized study in immunocomprised children with oropharyngeal thrush (in total 182, 5 months-14 years old). No differences in responses between girls and boys were observed (data not shown). Reported side effects were not stratified by sex .
Fluconazole has been associated with rare cases of serious hepatic toxicity, but no obvious relationship to sex or age of the patient has been observed. Caution is recommended if fluconazole is used in patients with liver dysfunction .
Regarding teratogenic aspects, please consult the Drugs and Birth Defects Database (in Swedish, Janusmed fosterpåverkan).
Date of litterature search: 2016-08-02
Reviewed by: Mia von Euler
Approved by: Karin Schenck-Gustafsson