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High-dose therapy with fluconazole > or = 800 mg day-1
K H Duswald1, A Penk, L Pittrow
1Chirurgische Klinik, Ludwig-Maximilians-Universität München, FR Germany.
Mycoses
|February 26, 1998
Summary
Higher fluconazole doses (over 800 mg/day) show good tolerance and improved efficacy for severe fungal infections in select patients. Further research is needed to optimize fluconazole treatment for candidemia and mycoses.
Area of Science:
- Mycology
- Infectious Diseases
- Clinical Pharmacology
Background:
- Fluconazole is a widely used antifungal agent.
- Current approved dosages may not be optimal for severe fungal infections.
Purpose of the Study:
- To evaluate the safety and efficacy of higher fluconazole dosages (greater than 800 mg/day).
- To assess dose-dependent responses in patients with serious fungal infections.
Main Methods:
- Review of data from approximately 900 patients treated with fluconazole dosages exceeding 800 mg/day.
- Analysis of dose-finding trials in non-neutropenic and HIV-infected patients.
Main Results:
- Higher fluconazole doses were well tolerated in patients with candidemia, oropharyngeal candidiasis, and cryptococcal meningitis.
- Dose-dependent responses were observed in patients with life-threatening infections caused by Candida spp., Cryptococcus neoformans, and Coccidioides immitis.
- An excellent safety profile was noted for dosages up to 2000 mg/day, with linear pharmacokinetics up to 1600 mg/day.
Conclusions:
- Higher daily fluconazole doses than currently approved appear safe and effective in selected patient populations.
- Further clinical investigation is warranted to determine optimal fluconazole dosage and treatment duration for severe fungal infections.