Effect of Body Weight and Age on the Pharmacokinetics of Dihydroartemisinin: Food and Drug Administration Basis for Dose Determination of Artesunate for Injection in Pediatric Patients With Severe Malaria.

Kitabi, Eliford; Bensman, Timothy J; Earp, Justin C; Chilukuri, Dakshina M; Smith, Heidi; Ball, Leslie; O'Shaughnessy, Elizabeth; Yasinskaya, Yuliya et al. · Clin Infect Dis · 2021

expert_opinion · Level V

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Abstract

For treatment of severe malaria, the World Health Organization recommends 3 mg/kg intravenous artesunate in pediatric patients weighing less than 20 kg. Here we describe the Food and Drug Administration's rationale for selecting 2.4 mg/kg in pediatric patients weighing less than 20 kg based on literature review and independent analyses.

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