Propranolol concentrations after oral administration in term and preterm neonates

L Filippi1, G Cavallaro, P Fiorini

  • 1Neonatal Intensive Care Unit, Medical Surgical Feto-Neonatal Department, A. Meyer University Children's Hospital, Florence, Italy. l.filippi@meyer.it

Insights

This study evaluated propranolol pharmacokinetics in neonates, finding drug levels proportional to dose but with a longer elimination half-life, suggesting slower metabolism in newborns. This is the first such evaluation in this population.

Area of Science:

  • Neonatal pharmacology
  • Pediatric pharmacokinetics
  • Drug metabolism

Background:

  • Propranolol pharmacokinetics is well-established in adults.
  • Limited data exists on propranolol pharmacokinetics in neonates.
  • Understanding neonatal drug metabolism is crucial for safe and effective treatment.

Purpose of the Study:

  • To evaluate propranolol pharmacokinetics in term and preterm neonates.
  • To compare neonatal propranolol pharmacokinetic parameters with adult values.
  • To assess the influence of gestational age and sex on propranolol pharmacokinetics in neonates.

Main Methods:

  • Oral propranolol administered at 0.5 or 0.25 mg/kg every 6 hours.
  • Propranolol concentrations measured via serial dried blood spots.
  • Pharmacokinetic parameters analyzed at steady state.

Main Results:

  • Propranolol levels were proportional to the administered dose.
  • Maximal, minimal, and average concentrations were similar to adults.
  • Elimination half-life was significantly longer in neonates compared to adults.
  • Apparent total body clearance was lower in neonates, indicating slower metabolism.
  • No significant differences observed between different gestational ages or sexes.

Conclusions:

  • Neonates achieve propranolol concentrations proportional to the administered dose.
  • Neonates exhibit a significantly longer elimination half-life for propranolol.
  • These findings suggest slower propranolol metabolism in neonates compared to adults.
Abstract

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