Single dose pharmacokinetics of pleconaril in neonates. Pediatric Pharmacology Research Unit Network

G L Kearns1, J S Bradley, R F Jacobs

  • 1Department of Pediatrics, University of Missouri-Kansas City, MO, USA. gkearns@cmh.edu

Insights

Pleconaril is safe for neonates with suspected enteroviral infections. Pharmacokinetics in neonates differ from children, suggesting a 5.0-mg/kg dose every 8-12 hours may be appropriate.

Area of Science:

  • Pharmacology
  • Neonatal Medicine
  • Infectious Diseases

Background:

  • Pleconaril is a broad-spectrum antipicornaviral agent.
  • It has demonstrated activity against nonpolio enteroviruses.

Purpose of the Study:

  • To evaluate the pharmacokinetics of pleconaril in neonates.
  • To compare pleconaril pharmacokinetics between neonates and children.

Main Methods:

  • 16 neonates received oral pleconaril (5 or 7.5 mg/kg).
  • Plasma concentrations were measured over 24 hours.
  • Pharmacokinetic parameters were determined and compared to data from children.

Main Results:

  • Pleconaril was well-tolerated in all neonates.
  • No significant pharmacokinetic differences were observed between the two doses in neonates.
  • Neonates showed different volume of distribution and Cmax/AUC compared to children, but similar elimination half-life.

Conclusions:

  • Age-dependent pharmacokinetic differences suggest higher bioavailability in older children/adults.
  • A 5.0-mg/kg dose every 8-12 hours is proposed for future neonatal studies.
  • Pleconaril shows promise for treating neonatal enteroviral infections.
Abstract

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