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Pharmacokinetics of oral ibuprofen for patent ductus arteriosus closure in preterm infants
  1. Bernard Barzilay1,2,
  2. Ilan Youngster2,3,
  3. David Batash1,2,
  4. Rimona Keidar1,2,
  5. Shaul Baram4,
  6. Michael Goldman2,5,
  7. Matithiahu Berkovitch2,3,
  8. Eli Heyman1
  1. 1Neonatal Intensive Care Unit, Assaf Harofeh Medical Center, Zerifin, Israel
  2. 2Sackler faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
  3. 3Clinical Pharmacology Unit, Assaf Harofeh Medical Center, Zerifin, Israel
  4. 4Paediatric Cardiology Unit, Assaf Harofeh Medical Center, Zerifin, Israel
  5. 5Paediatric Division, Assaf Harofeh Medical Center, Zerifin, Israel
  1. Correspondence to Ilan Youngster, Clinical Pharmacology Unit, Assaf Harofeh Medical Center, Zerifin 70300, Israel; ilanyoungster{at}


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.

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  • BB and IY contributed equally to this work.

  • Competing interests None.

  • Ethics approval This study was conducted with the approval of the Institutional review board – Assaf Harofeh Medical Center, Israel.

  • Provenance and peer review Not commissioned; externally peer reviewed.