Population pharmacokinetics of fluconazole for prevention or treatment of invasive candidiasis in Chinese young infants.

Fluconazole dosing for young infants at risk of invasive candidiasis has remained largely empirical due to limited pharmacokinetic data in this population. This study used 304 plasma samples from 183 Chinese infants under 120 days old to build a population pharmacokinetic model with Phoenix NLME, then used Monte Carlo simulation to evaluate target attainment for prophylactic and therapeutic dosing regimens. Gestational age, postnatal age, and body weight were significant covariates for fluconazole clearance and volume of distribution, and simulations showed that while standard prophylactic doses were adequate, higher doses might be needed to treat invasive candidiasis, particularly in younger infants. The model supports dosing adjustments based on gestational and postnatal age to achieve target fluconazole exposure in young infants.