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. (19th February 2021)

• Record Type: Journal Article
• Authors: Kitabi, Eliford; Bensman, Timothy J; Earp, Justin C; Chilukuri, Dakshina M; Smith, Heidi; Ball, Leslie; O'Shaughnessy, Elizabeth; Yasinskaya, Yuliya; Colangelo, Philip M; Reynolds, Kellie S
• Is Part Of: Clinical infectious diseases. Volume 73:Number 5(2021)
• Page Start: 903
• Page End: 906
• Publication Date: 2021-02-19
• Subjects: artesunate -- dihydroartemisinin -- severe malaria -- pediatric dose selection -- pharmacokinetic modeling and simulation; Communicable diseases -- Periodicals; 616.905
• DOI: 10.1093/cid/ciab149
• Languages: English
• ISSNs: 1058-4838

Abstract

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.