Efficacy and safety of gentamicin by interval and intravenous dosage adjustment based on the gestational age in Thai neonates.
OBJECTIVE
To determine the pharmacological efficacy and safety of the gentamicin regimen that adjusts intravenous dose and interval based on the gestational age (GA) in Thai neonates.


METHODS
Neonates aged < or = 7 days, who had received gentamicin for clinically suspected or high risk of sepsis and had no contraindication to gentamicin usage were enrolled. They were stratified into four groups by GA as < or = 29, 30-33, 34-37 and > or = 38 weeks gestation. Gentamicin administration in each group was 5, 4.5, 4 and 4 mg/kg/dose every 48, 36, 36 and 24 hours respectively according to Neofax regimen. Peak serum gentamicin concentration (SGC), trough SGC and serum creatinine (Cr) were obtained.


RESULTS
Forty-nine neonates were enrolled. Forty-four (89.7%) had peak SGC within the desirable range (5-12 mg/L). Three neonates had slightly high peak SGC. Their peak SGCs were 13.0, 12.21 and 12.20 mg/L. Two neonates had slightly low peak SGC. Their peak SGCs were 4.91 and 4.4 mg/L. All neonates had trough SGC below 2 mg/L. None had significant rising of serum Cr during the present study period.


CONCLUSIONS
This gentamicin regimen yielded good pharmacological efficacy and safety in Thai neonates, who were in the first week of life and had no renal function impairment.
Tantiprabha
Watcharee
W
Department of Pediatrics, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.
Juntarakana
Sujitra
S
Chotinaruemol
Somporn
S
Rojanasthien
Noppamas
N
D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D005839:Gentamicins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005865:Gestational Age; D006801:Humans; D007229:Infant Welfare; D007231:Infant, Newborn; D007275:Injections, Intravenous; D008297:Male; D011446:Prospective Studies; D012307:Risk Factors; D018805:Sepsis / Q000188:drug therapy* / Q000517:prevention & control; D013785:Thailand; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D005839:Gentamicins