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Pharmacokinetics of oral and intravenous indomethacin in preterm infants
Insights
Indomethacin
Area of Science:
- Neonatal pharmacology
- Pediatric pharmacokinetics
- Cardiology in neonates
Background:
- Patent ductus arteriosus (PDA) is common in preterm infants.
- Indomethacin is a common treatment for PDA.
- Understanding indomethacin pharmacokinetics in neonates is crucial.
Purpose of the Study:
- To characterize the pharmacokinetic profile of indomethacin in preterm infants with PDA.
- To compare oral versus intravenous administration.
- To assess the influence of gestational age on indomethacin pharmacokinetics.
Main Methods:
- 13 preterm infants with significant PDA were studied.
- 9 received oral indomethacin, 4 received intravenous therapy.
- Plasma concentrations and half-life were measured.
Main Results:
- Plasma half-life was significantly prolonged in preterm infants compared to adults.
- Half-life correlated with gestational age (shorter in >32 weeks gestation).
- Oral bioavailability was 13%; protein binding and distribution volume were similar to adults.
Conclusions:
- Indomethacin exhibits prolonged half-life in preterm infants, influenced by gestational age.
- No serious complications were observed at the studied doses.
- Pharmacokinetic data supports appropriate dosing for neonates with PDA.
Abstract:
The pharmacokinetic profile of indomethacin administered either orally or intravenously in 13 preterm infants with significant patent ductus arteriosus (PDA) is reported. 9 infants received oral indomethacin and 4 received intravenous therapy. Plasma half-life was significantly prolonged as compared to adult values and demonstrated significant correlation with gestational age. Mean half-life in neonates less than 32 weeks gestation was 17.2 (0.8) vs. 12.5 (0.5) h for neonates greater than 32 weeks gestation. Bioavailability of the oral dosage based on AUC was 13% but no difference was observed in the plasma protein binding or distribution volume of drug as compared to adult values. No serious complications could be attributed to the use of indomethacin at these dose levels in the premature infant.