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Once-daily gentamicin dosing of 4 Mg/Kg/dose in neonates

Pakaphan Kiatchoosakun1, Pope Kosalaraksa, Junya Jirapradittha

  • 1Division of Neonatology, Department of Pediatrics, Faculty of Medicine, Khon Kaen University, Khon Kaen 40002, Thailand.

Journal of the Medical Association of Thailand = Chotmaihet Thangphaet
|October 26, 2005
PubMed

Insights

A once-daily gentamicin dose of 4 mg/kg is effective and safe for neonatal sepsis treatment. This optimized neonatal gentamicin regimen achieved therapeutic peak levels while maintaining safe trough levels, avoiding nephrotoxicity and ototoxicity.

Area of Science:

  • Neonatal pharmacology
  • Pediatric infectious diseases
  • Antibiotic stewardship

Background:

  • Gentamicin is a critical antibiotic for neonatal sepsis, but optimal dosing requires balancing efficacy and toxicity.
  • Traditional twice-daily dosing may not be ideal due to gentamicin's pharmacokinetic properties in neonates.
  • Previous studies indicated potential toxicity with higher once-daily doses.

Purpose of the Study:

  • To evaluate the efficacy and safety of a once-daily gentamicin regimen of 4 mg/kg in neonates.
  • To determine peak and trough serum gentamicin concentrations.
  • To assess for nephrotoxicity and ototoxicity.

Main Methods:

  • A study of 105 neonates (gestational age ≥34 wk or weight ≥2,000 g) with suspected or confirmed sepsis.
  • Intravenous administration of gentamicin at 4 mg/kg once daily.
  • Serum gentamicin concentrations (peak and trough) measured on day 3.
  • Nephrotoxicity assessed by serum creatinine and ototoxicity by hearing tests on days 1 and 3.

Main Results:

  • Mean steady-state peak concentration was 7.33 µg/mL (therapeutic), and trough concentration was 0.99 µg/mL (safe).
  • 97% of neonates achieved therapeutic peak levels (>4 µg/mL).
  • Only 6.67% had undesirable trough levels (>2 µg/mL), with no identified nephrotoxic or ototoxic effects.

Conclusions:

  • Once-daily gentamicin at 4 mg/kg is effective for neonatal sepsis in neonates ≥34 wk gestation.
  • This dosing regimen achieves appropriate trough levels and is convenient.
  • The 4 mg/kg once-daily regimen did not increase renal or ototoxicity in the studied neonates.

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