| Pharmacokinetics
Steinhorn et al10 performed a multicentre, open-label, dose-escalation, pilot, pharmacokinetics study of 36 near-term and term neonates with echo-confirmed idiopathic PHN or secondary PHN with MAS, RDS, sepsis or pneumonia and OI ≥ 15. The study included 8 sequential ‘‘step-up’’ dosing groups. Most infants received a loading dose of sildenafil to bring the plasma concentration of sildenafil to a target, followed by a maintenance infusion for the remainder of the study. The duration of IV sildenafil was for at least 48 hours and up to 7 days. They found sildenafil to be well tolerated, particularly with a dosing regimen comprising a loading dose of 0.4 mg/kg delivered over 3 hours, followed by a maintenance infusion at 1.6 mg/kg/day.
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