Population Pharmacokinetics of Amikacin in Indian Pediatric Patients

Clinical Research and Regulatory Affairs Pub Date : 2008-01-01 DOI:10.1080/10601330802383441

Butchi Raju Akondi, R. Chodavarapu, K. Devarakonda

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Abstract

The aim of this study was to describe population pharmacokinetics of amikacin in Indian pediatric population. Dosage adjustment based on individual pharmacokinetic parameters is of considerable importance for effective and safe use of drugs. Extensive work on amikacin and other aminoglycosides was carried out in different pediatric patient populations but no data are available in Indian pediatric patients. In the present study 74 steady state concentrations of amikacin were analyzed from 42 patients. Pharmacostatistical work was done by using NONMEM. The covariates evaluated in this study were age, body weight, height, and sex and creatinine clearance. The model found to best describe the data following FO method was: Clearance (CL) = θ1*(wt/14.2)*exp. (η1) and volume (V) = θ2*exp (η2) and following FOCE method was: Clearance (CL) = θ1*(age/5.38) + θ3*(wt/14.2)*exp.(η1) and volume(V) = θ2*exp(η2). The final model estimates of CL and V estimated by FO method were1.02 L/h and 4.55L respectively and by FOCE method were1.07L/hr and 4.91L respectively. These parameters are utilized for individualizing the loading and maintenance doses in pediatric patients.

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阿米卡星在印度儿科患者中的人群药代动力学

本研究的目的是描述阿米卡星在印度儿科人群中的群体药代动力学。基于个体药代动力学参数的剂量调整对于药物的有效和安全使用具有相当重要的意义。对阿米卡星和其他氨基糖苷的广泛研究在不同的儿科患者群体中进行，但没有印度儿科患者的数据。本研究分析了42例患者的74例阿米卡星稳态浓度。采用NONMEM进行药物统计工作。本研究评估的协变量包括年龄、体重、身高、性别和肌酐清除率。采用FO方法得到的最能描述数据的模型为:Clearance (CL) = θ1*(wt/14.2)*exp。(η1)，体积(V) = θ2*exp(η2)，采用的FOCE方法为:清除率(CL) = θ1*(年龄/5.38)+ θ3*(wt/14.2)*exp (η1)，体积(V) = θ2*exp(η2)。FO法估算的CL和V最终模型估计值分别为1.02 L/h和4.55L, FOCE法估算的CL和V最终模型估计值分别为1.07L/h和4.91L。这些参数用于个性化儿科患者的负荷和维持剂量。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Clinical Research and Regulatory Affairs

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