title: Fluconazole pharmacokinetics and safety in premature infants.
abstract: Invasive candidiasis (IC) in the premature infant population is a common infection that results in substantial morbidity and mortality. For these patients, fluconazole is among the first line therapies to treat and prevent IC, and yet few prospective studies investigating its pharmacokinetics (PK) and safety have been performed in this vulnerable population. We review five phase I studies examining the PK of fluconazole in premature infants, which demonstrate markedly differing kinetics compared to adults. Based on these data, a treatment dose of 12 mg/kg/day, with the potential need of a loading dose of 25 mg/kg to achieve rapid steady state concentrations, achieves surrogate pharmacodynamic targets. Additionally, fluconazole appears to be safe to use in this population, with only minimal reversible hepatobiliary effects.
authors.affiliation: Department of Pediatrics, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
authors.forename: K
authors.initials: K
authors.lastname: Turner
authors.forename: P
authors.initials: P
authors.lastname: Manzoni
authors.forename: D K
authors.initials: DK
authors.lastname: Benjamin
authors.forename: M
authors.initials: M
authors.lastname: Cohen-Wolkowiez
authors.forename: P B
authors.initials: PB
authors.lastname: Smith
authors.forename: M M
authors.initials: MM
authors.lastname: Laughon
mesh_terms: D000935:Antifungal Agents / Q000493:pharmacokinetics / Q000627:therapeutic use; D058365:Candidiasis, Invasive / Q000188:drug therapy; D002986:Clinical Trials as Topic; D015725:Fluconazole / Q000493:pharmacokinetics* / Q000627:therapeutic use; D006207:Half-Life; D006801:Humans; D007231:Infant, Newborn; D007234:Infant, Premature
chemical_list: D000935:Antifungal Agents; D015725:Fluconazole