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Pharmacokinetics and tolerance of zidovudine in preterm infants

Edmund V Capparelli1, Mark Mirochnick, Wayne M Dankner

  • 1University of California, San Diego, USA. ecapparelli@ucsd.edu

The Journal of Pediatrics
|January 10, 2003
PubMed

Insights

Zidovudine clearance is significantly lower in premature infants. Recommended dosing adjustments are crucial for managing human immunodeficiency virus exposure in this vulnerable population.

Area of Science:

  • Neonatal pharmacology
  • Pediatric infectious diseases
  • Clinical pharmacokinetics

Background:

  • Premature infants exposed to HIV require careful management.
  • Zidovudine (AZT) is a key antiretroviral medication.
  • Understanding AZT pharmacokinetics in preterm neonates is critical for safe and effective dosing.

Purpose of the Study:

  • To evaluate the pharmacokinetics and tolerance of zidovudine in premature infants exposed to HIV.
  • To establish optimal dosing strategies for zidovudine in this specific population.

Main Methods:

  • Prospective, multicentered, open-label study (Pediatric AIDS Clinical Trials Group Study 331).
  • Enrolled 38 infants with gestational age <35 weeks.
  • Administered weight-based zidovudine doses, adjusted based on postnatal age and pharmacokinetic monitoring.

Main Results:

  • Zidovudine clearance was notably lower in premature infants compared to term infants.
  • Nine infants required dose reductions due to elevated zidovudine levels.
  • Postnatal age, gestational age, serum creatinine, and furosemide use were independent predictors of zidovudine clearance.

Conclusions:

  • Zidovudine clearance is substantially reduced in premature infants.
  • A modified dosing schedule is recommended: 1.5 mg/kg IV or 2.0 mg/kg PO every 12 hours, increasing to every 8 hours at 2-4 weeks of age based on gestational age.
  • Zidovudine was generally well-tolerated in this high-risk group.
Abstract

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