Validation of a Dosage Individualization Table for Extended-Interval Gentamicin in Neonates

Abstract

BACKGROUND: Extended-interval aminoglycoside dosing is increasingly used in neonates; however, guidance on how to monitor concentrations and adjust dosages accordingly is limited. OBJECTIVE: To prospectively validate the use of a 22-hour gentamicin concentration dosing table for the individualization of extended-interval dosing in the neonatal population by examining the peak and trough concentrations achieved through its use. METHODS: A prospective observational study was carried out on gentamicin concentrations achieved using a 22-hour post–first-dose gentamicin concentration dosing table for determining dosing intervals in neonates. Neonates (N = 104) in the first week of life, gestational age 23 weeks to full term, in level II and III neonatal intensive care units were included. Neonates were given gentamicin 5 mg/kg intravenously; a table using 22-hour post-first-dose gentamicin concentrations was then used to individualize dosing intervals. Pre- and post-serum gentamicin concentrations on the dosing interval indicated were measured with the second or third doses and used to calculate the peak and trough concentrations achieved. RESULTS: Use of the 22-hour post-first-dose gentamicin concentration dosing table resulted in dosing intervals that provided appropriate peak (mean 10.55 mg/L) and trough (mean 0.75 mg/L) concentrations (with second or third doses) in all neonates. All patients had trough concentrations less than 2 mg/L, and 73% had a trough concentration less than 1 mg/L. No peak concentrations were less than 5 mg/L, 82% of patients had a peak concentration from 5 to 12 mg/L, and the remaining 18% had concentrations from 12.1 to 16 mg/L. Peak and trough concentrations were similar across all gestational ages. CONCLUSIONS: Use of a 22-hour post-first-dose gentamicin concentration dosing table to individualize extended-interval gentamicin dosages in neonates resulted in appropriate peak and trough concentrations in all neonates studied. Use of this table will result in appropriate extended-interval aminoglycoside dosages in neonates early in treatment, using a single serum concentration.