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Fluconazole

Classification: A

Drug products: Diflucan, Diflucan®, Fluconazol Actavis, Fluconazol Aurobindo, Fluconazol Bluefish, Fluconazol Copyfarm, Fluconazol Fresenius Kabi, Fluconazol Hexal, Fluconazol HEXAL, Fluconazol Krka, Fluconazol Pharmathen, Fluconazol Sandoz, Fluconazol Takeda, Fluconazol Villerton, Fluconazole Accord, Fluconazole B. Braun, Fluconazole Baxter, Flukonazol 2care4, Flukonazol Ebb, Flukonazol IVAX, Flukonazol Medartuum, Flukonazol Mylan, Flukonazol NM Pharma, Solona

ATC code: J02AC01

Substances: fluconazole

Summary

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.

Additional information

Pharmacokinetics and dosing

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 [1]. Similar results were observed in a study in Chinese volunteers (5 men, 5 women) receiving fluconazole 200 mg single dose [2]. A study in HIV-positive patients (93 men, 29 women) observed no effect on patient’s sex on fluconazole pharmacokinetics [3].

Effects

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 [4].

Adverse effects

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 [5].

Reproductive health issues

Regarding teratogenic aspects, please consult the Drugs and Birth Defects Database (in Swedish, Janusmed fosterpåverkan).

Updated: 2019-02-26

Date of litterature search: 2016-08-02

References

  1. Carrasco-Portugal Mdel C, Flores-Murrieta FJ. Gender differences in the oral pharmacokinetics of fluconazole. Clin Drug Investig. 2007;27:851-5. PubMed
  2. Guo T, Sun WJ, Xia DY, Zhao LS. The pharmacokinetics of fluconazole in healthy Chinese adult volunteers: influence of ethnicity and gender. J Clin Pharm Ther. 2010;35:231-7. PubMed
  3. Csajka C, Décosterd LA, Buclin T, Pagani JL, Fattinger K, Bille J et al. Population pharmacokinetics of fluconazole given for secondary prevention of oropharyngeal candidiasis in HIV-positive patients. Eur J Clin Pharmacol. 2001;57:723-7. PubMed
  4. Flynn PM, Cunningham CK, Kerkering T, San Jorge AR, Peters VB, Pitel PA et al. Oropharyngeal candidiasis in immunocompromised children: a randomized, multicenter study of orally administered fluconazole suspension versus nystatin The Multicenter Fluconazole Study Group. J Pediatr. 1995;127:322-8. PubMed
  5. Diflucan (flukonazol). Summary of Product Characteristics. Medical Products Agency Sweden; 2015.
  6. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2015 [cited 2016-08-02.] Socialstyrelsens statistikdatabas

Authors: Linnéa Karlsson Lind

Reviewed by: Mia von Euler

Approved by: Karin Schenck-Gustafsson