Characteristics of the studies, pharmacokinetics and dose recommendations of isolated studies on fluconazole
Study | n | PNA | Weight | Study design | Group | Model | Modality | Administered dose | Vd | CL | t1/2 (hours) | Recommended dose |
Watt et al,24 USA | 40 | 22 | 3.4 | P 2 groups | Infants | 1-compartment with NONMEM | VV | 25 mg/kg loading dose followed by 12 mg/kg/day maintenance therapy | For neonates (ECMO vs non-ECMO): 1.5 (1.3–1.8) vs 0.96 (0.55– 1.4) L/kg ↑56.2% For infants (ECMO vs non-ECMO): 1.2 (0.91– 1.6) vs 0.83 (0.72–1.0) L/kg ↑44.6% | For neonates (ECMO vs non-ECMO): 0.018 (0.013– 0.043) vs 0.018 (0.008– 0.042) L/hour/kg ↔ For infants (ECMO vs non-ECMO): 0.022 (0.011– 0.039) 0.017 (0.008–0.029) L/hour/kg ↑29.4% | — | 12 mg/kg for prophylaxis 35 mg/kg for invasive candidiasis treatment |
Boldfaced fonts represent comparisons with controls within the same study. In other studies, they represent comparisons with non-ECMO neonates from a different published study.
CL, clearance; ECMO, extracorporeal membrane oxygenation; NONMEM, non-linear mixed-effects modelling; P, prospective; PNA, postnatal age; t1/2, elimination half-life; Vd, volume of distribution; VV, veno-venous.