Journal of Clinical Pharmacology • April 2026
Randell RL, Maharaj A, Laughon M, Hornik CD, Greenberg RG, Lang JE, Cohen-Wolkowiez M, Hornik CP, Anand R, Martz K, Payne EH, Watt K, Muller WJ, Courtney SE, Atz A, Al-Uzri A, Sokol GM, Bloom BT, Iyengar A, Hanna M, Benjamin DK Jr, Balevic SJ; Best Pharmaceuticals for Children Act – Pediatric Trials Network Steering Committee.
Furosemide is the most commonly used diuretic in preterm infants despite an incompletely understood relationship between dosing, exposure, and safety within this population. The goals of this study were to characterize furosemide population pharmacokinetics (popPK) in preterm infants and to evaluate safety by relating simulated furosemide exposure to events of ototoxicity, nephrocalcinosis, and nephrolithiasis. A total of 146 plasma furosemide concentrations from 51 preterm (23-28.9 weeks’ gestational age) infants across two studies (one randomized, placebo-controlled, dose-escalating safety trial and one opportunistic, observational study) were included in the analysis. Standard nonlinear mixed effects popPK modeling techniques were applied.