Pharmacokinetics of oral ibuprofen for patent ductus arteriosus closure in preterm infants.

BACKGROUND: Oral ibuprofen has been shown to be associated with excellent patent ductus arteriosus (PDA) closure rates and a favourable safety profile, but limited data exist regarding its pharmacokinetics in preterm infants.

OBJECTIVE: To evaluate pharmacokinetic parameters of oral ibuprofen in preterm infants.

METHODS: Plasma ibuprofen levels were determined at various time points, and pharmacokinetic profiles were calculated after a single dose of 10 mg/kg of oral ibuprofen. The rate of ductal closure, adverse effects and patients' clinical course were recorded.

RESULTS: The authors studied 13 preterm infants (mean gestational age±SD 27.8±2.4 weeks, mean birth weight 1052±443 g). PDA closure was obtained in all patients after a single dose. Ibuprofen levels were detectable 1 h after administration, peaked after 8 h and remained in a relative plateau until 24 h postadministration. Area under the curve (AUC)0→24 was higher than levels reported with intravenous treatment. No adverse effects were observed.

CONCLUSION: Oral administration of ibuprofen in very preterm infants is associated with excellent absorption and a high AUC0→24, and may be an alternative to intravenous administration.