Administration of fluconazole in children below 1 year of age.

For this review, 78 studies regarding the use of fluconazole in a total of 726 children below 1 year of age were evaluated. The range of fluconazole dosage was 2-50 mg kg-1 day-1, with 162 days being the maximum duration of treatment. According to current experience, fluconazole seems to be well tolerated and efficacious against systemic candidosis and candidaemia in children below 1 year of age, including neonates and very low-birthweight infants (VLBWIs). The recommended daily dosage is 6 mg kg-1. (In Germany, fluconazole is approved for children between 1 and 16 years in cases in which there is no therapeutic alternative for treatment of systemic infections caused by Candida spp. and Cryptococcus neoformans in a dosage of 3-6 mg kg-1 day-1 and for superficial Candida infections in a dosage of 1-2 mg kg-1 day-1.) In patients with impaired renal function, the daily dose should be reduced in accordance with the guidelines given for adults. In neonates during the first 2 weeks of life, this dosage should be administered only every 72 h. In weeks 2-4 of life, the same dose should be given every 48 h, following which daily dosing is appropriate. This posology is derived from the age-related pharmacokinetics of fluconazole, with a higher volume of distribution and a prolonged plasma elimination half-life, especially during the first month of life. Drug monitoring during treatment should be performed to ensure therapeutic plasma concentrations of fluconazole within a range between 4 and 20 micrograms ml-1. The benefit of fluconazole should be investigated in prospective studies for treatment of systemic candidosis with administration of higher dosages as well as for early empiric therapy in VLBWIs.