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Once versus twice daily amikacin in neonates: prospective study on toxicity.

Author(s): Kotze A, Bartel PR, Sommers DK

Affiliation(s): Department of Pharmacology, Faculty of Medicine, University of Pretoria, South Africa. akotze@medic.up.ac.za

Publication date & source: 1999-06, J Paediatr Child Health., 35(3):283-6.

Publication type: Clinical Trial; Comparative Study ; Randomized Controlled Trial

OBJECTIVE: To compare the potentially toxic effects in fullterm neonates of amikacin administered once daily, versus amikacin administered twice daily. METHODOLOGY: A controlled, randomized, prospective study in which one group of fullterm neonatal patients received amikacin 15 mg/kg per dose once daily (n = 20), and the other received amikacin 7.5 mg/kg per dose twice daily (n = 20). Impairment of renal glomerular function was defined as a decline of less than 50% of the expected physiological drop in serum creatinine over time. Brainstem auditory evoked potentials were also evaluated and amikacin blood levels taken. RESULTS: Fifteen patients in the once-daily group and 12 patients in the twice-daily group demonstrated at least one period of renal function impairment while in hospital. This decreased to five of 16 and four of 16 patients during follow-up. These differences were not statistically significant. Brainstem auditory evoked potentials did not find signs of ototoxicity at any time. CONCLUSION: In fullterm neonatal patients, once daily dosing of amikacin is no more toxic than the twice daily regimen.

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