Amikacin Pharmacokinetics and a New Dosing Guideline in Korean Neonates
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The objectives of this study is to evaluate the correlations between patient characteristics and amikacin pharmacokinetics, and develop a new dosing regimen for Korean neonates. This study was conducted in the Neonatal Intensive Care Unit at Asan Medical Center in Seoul, Korea, between February 2003 and February 2005. Demographic and pharmacokinetic data were collected for 107 neonates of 24 to 41 weeks` gestational age (GA) treated with amikacin and received therapeutic drug monitoring by a pharmacist. The medication was infused over 30 minutes and 268 serum amikacin concentrations (134 peak and trough pairs) were taken at steady state. The pharmacokinetic parameters of amikacin in the study population were as follows: Vd (0.56 ± 0.13 L/kg), t1/2 (6.6 ± 4.1 hr), K (0.14 ± 0.06 hr-1) and CL (0.07 ± 0.03 L kg-1 hr-1). CL (L kg-1 hr-1) significantly increased with body weight (CL = 1.795 × 10-5 × body weight + 0.038), postnatal age (CL = 0.001 × PNA + 0.057), postconceptional age (CL = 0.004 × PCA - 0.073) and decreased with serum creatinine (CL = -0.045 × Scr + 0.107) (P 0.001). The mean peak and trough concentrations were 26.9 ± 7.8 and 3.4 ± 3.3 μg/mL, respectively. The overall ratios within the therapeutic range of peak (20~30 μg/mL) and trough (2~5 μg/mL) were 50.8 and 44.8%, respectively. Compared to the current therapy, the dose was reduced from 15~18 mg/kg to 13 mg/kg in neonates with PNA ≤ 7 days while dose increased from 12 mg/kg to 13 mg/kg in neonates with PNA ≥ 8 days in the new dosing guideline. The dosing interval was prolonged from 24 to 36 hr in neonates with PCA ≤ 29 and PNA ≥ 8 days. CL was influenced by PCA and PNA, and a new dosing guideline was constructed based on the results.
Abstract
The objectives of this study is to evaluate the correlations between patient characteristics and amikacin pharmacokinetics, and develop a new dosing regimen for Korean neonates. This study was conducted in the Neonatal Intensive Care Unit at Asan Medical Center in Seoul, Korea, between February 2003 and February 2005. Demographic and pharmacokinetic data were collected for 107 neonates of 24 to 41 weeks` gestational age (GA) treated with amikacin and received therapeutic drug monitoring by a pharmacist. The medication was infused over 30 minutes and 268 serum amikacin concentrations (134 peak and trough pairs) were taken at steady state. The pharmacokinetic parameters of amikacin in the study population were as follows: Vd (0.56 ± 0.13 L/kg), t1/2 (6.6 ± 4.1 hr), K (0.14 ± 0.06 hr-1) and CL (0.07 ± 0.03 L kg-1 hr-1). CL (L kg-1 hr-1) significantly increased with body weight (CL = 1.795 × 10-5 × body weight + 0.038), postnatal age (CL = 0.001 × PNA + 0.057), postconceptional age (CL = 0.004 × PCA - 0.073) and decreased with serum creatinine (CL = -0.045 × Scr + 0.107) (P 0.001). The mean peak and trough concentrations were 26.9 ± 7.8 and 3.4 ± 3.3 μg/mL, respectively. The overall ratios within the therapeutic range of peak (20~30 μg/mL) and trough (2~5 μg/mL) were 50.8 and 44.8%, respectively. Compared to the current therapy, the dose was reduced from 15~18 mg/kg to 13 mg/kg in neonates with PNA ≤ 7 days while dose increased from 12 mg/kg to 13 mg/kg in neonates with PNA ≥ 8 days in the new dosing guideline. The dosing interval was prolonged from 24 to 36 hr in neonates with PCA ≤ 29 and PNA ≥ 8 days. CL was influenced by PCA and PNA, and a new dosing guideline was constructed based on the results.