Once versus twice daily dose of gentamicin therapy in Thai neonates

J Med Assoc Thai. 2004 Apr;87(4):372-6.

Abstract

Objective: To compare the peak and trough gentamicin concentrations in neonates after a once (ODD) vs. twice daily dosing (TDD) to establish the appropriate dosage for Thai neonates.

Material and method: Neonates of gestational age > or = 34 weeks, or body weight > or = 2000 g, suspected of having bacterial infection were randomized to receive gentamicin intravenously, either 5 mg/kg every 24 hours or 2.5 mg/kg every 12 hours. The peak and trough serum gentamicin levels (SGLs) were measured. Serum creatinine cued nephrotoxicity.

Results: Neonates were evaluated and baseline characteristics between the groups were compared. The ODD and TDD group had a mean gentamicin peak and trough concentration of 10.1 +/- 3.0 vs. 7.8 +/- 2.0 microg/ml (p < 0.05) and 1.6 +/- 1.1 vs. 2.6 +/- 1.2 microg/ml (p < 0.05), respectively. The peak SGL of > or = 4 microg/ml was achieved in 100% vs. 96% of the ODD vs. TDD group, respectively. SGL troughs > or = 2 microg/ml were detected less often in the ODD group (22% vs. 68%, p < 0.05). Abnormal change in serum creatinine was not observed in either group.

Conclusion: A once daily dose of gentamicin 5 mg/kg achieved a significantly higher peak SGL and safer trough than a twice-daily dose of 2.5 mg/kg albeit about a quarter of the ODD group had high troughs. A single daily dose of gentamicin 3.5-4 mg/kg/d in Thai neonates should be tested.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Anti-Bacterial Agents / administration & dosage*
  • Anti-Bacterial Agents / pharmacokinetics*
  • Drug Administration Schedule
  • Gentamicins / administration & dosage*
  • Gentamicins / pharmacokinetics*
  • Humans
  • Infant, Newborn
  • Sepsis / drug therapy

Substances

  • Anti-Bacterial Agents
  • Gentamicins