Gentamicin Dosing in Neonates with Normal Renal Function: Trough and Peak Levels

Eur J Drug Metab Pharmacokinet. 2021 Sep;46(5):677-684. doi: 10.1007/s13318-021-00708-x. Epub 2021 Aug 9.

Abstract

BACKGROUND AND OBJECTIVE: Gentamicin is commonly used in neonates, and it requires drug concentration monitoring. The objective of this study was to determine the extent of high trough (≥ 2 mg/l) and therapeutic peak serum gentamicin concentrations (5-12 mg/l) using our current gentamicin regimen and to adjust the dosing regimen accordingly and reassess.

Methods: This was a prospective cohort study of neonates, with normal renal function, who were prescribed gentamicin. Group 1: March 2014-July 2017-gentamicin intravenous (IV) 2.5 mg/kg given every 36 h if < 30 weeks gestational age (GA) and every 24 h if ≥ 30 weeks GA; Group 2: August 2019-February 2020-gentamicin IV 3.5 mg/kg given every 36 h if < 30 weeks GA and every 24 h if ≥ 30 weeks GA. We assessed the number of neonates with aberrant trough and peak serum gentamicin concentrations.

Results: Forty-eight neonates < 30 weeks GA and 34 ≥ 30 weeks GA were given 2.5 mg/kg gentamicin. Eleven (23%) neonates < 30 weeks GA and four (13%) ≥ 30 weeks GA had subtherapeutic peak concentrations (< 5 mg/l); none had supratherapeutic (> 12 mg/l) or toxic trough concentrations (≥ 2 mg/l). Forty-four neonates < 30 weeks GA and 54 ≥ 30 weeks GA were given 3.5 mg/kg gentamicin. Eighty-four (86%) had non-toxic trough concentrations (< 2 mg/l). One (1%) < 30 weeks GA neonate had subtherapeutic (< 5 mg/l) and one (1%) neonate ≥ 30 weeks GA had supratherapeutic (> 12 mg/l) peak concentrations.

Conclusions: Gentamicin regimen of 2.5 mg/kg given every 36 h for neonates < 30 weeks GA and every 24 h for neonates ≥ 30 weeks GA was suboptimal at achieving therapeutic gentamicin peak. Increasing the dosage to 3.5 mg/kg achieved therapeutic peak concentrations in 98% and non-toxic trough concentrations in 86% of all neonates (prior to dose interval adjustment).

Publication types

  • Comparative Study

MeSH terms

  • Administration, Intravenous
  • Anti-Bacterial Agents / administration & dosage*
  • Anti-Bacterial Agents / pharmacokinetics
  • Cohort Studies
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Drug Monitoring / methods*
  • Female
  • Follow-Up Studies
  • Gentamicins / administration & dosage*
  • Gentamicins / pharmacokinetics
  • Gestational Age
  • Humans
  • Infant, Newborn
  • Kidney Function Tests
  • Male
  • Prospective Studies

Substances

  • Anti-Bacterial Agents
  • Gentamicins