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-Reference-Cited by-同舟云学术

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

Published:2021-02-19 Issue:5 Volume:73 Page:903-906
ISSN:1058-4838
Container-title:Clinical Infectious Diseases
language:en
Short-container-title:

Author:

Kitabi Eliford¹,Bensman Timothy J²,Earp Justin C¹,Chilukuri Dakshina M²,Smith Heidi³,Ball Leslie³,O’Shaughnessy Elizabeth³,Yasinskaya Yuliya³,Colangelo Philip M²,Reynolds Kellie S²

Affiliation:

1. Division of Pharmacometrics, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA

2. Division of Infectious Disease Pharmacology, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA

3. Division of Anti-infectives, Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA

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.

Publisher

Oxford University Press (OUP)

Subject

Infectious Diseases,Microbiology (medical)

Link

http://academic.oup.com/cid/advance-article-pdf/doi/10.1093/cid/ciab149/36781372/ciab149.pdf

Reference18 articles.

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2. Artesunate versus quinine in the treatment of severe falciparum malaria in African children (AQUAMAT): an open-label, randomised trial;Dondorp;Lancet,2010

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