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Pharmacokinetics of oseltamivir in infants under the age of 1 year

BACKGROUND: Oseltamivir is the only antiviral treatment recommended for influenza in young children over the age of 1 year. There is scant data on oseltamivir pharmacokinetics (PK) in infants <1 year. We set out to perform PK measurements in infants who received oseltamivir. METHODS: This study w...

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Autores principales: Dixit, Rashmi, Matthews, Slade, Khandaker, Gulam, Walker, Karen, Festa, Marino, Booy, Robert
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Berlin Heidelberg 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5011461/
https://www.ncbi.nlm.nih.gov/pubmed/27596232
http://dx.doi.org/10.1186/s40169-016-0118-1
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author Dixit, Rashmi
Matthews, Slade
Khandaker, Gulam
Walker, Karen
Festa, Marino
Booy, Robert
author_facet Dixit, Rashmi
Matthews, Slade
Khandaker, Gulam
Walker, Karen
Festa, Marino
Booy, Robert
author_sort Dixit, Rashmi
collection PubMed
description BACKGROUND: Oseltamivir is the only antiviral treatment recommended for influenza in young children over the age of 1 year. There is scant data on oseltamivir pharmacokinetics (PK) in infants <1 year. We set out to perform PK measurements in infants who received oseltamivir. METHODS: This study was a prospective, uncontrolled, open label evaluation of the pharmacokinetics of oseltamivir metabolism, safety of oseltamivir, viral clearance in infants <12 months diagnosed with influenza by nasopharyngeal influenza nucleic acid antigen test (NAAT). Blood levels of the prodrug oseltamivir and its active carboxylate were measured prior to a dose of oseltamivir and at 4 time points afterwards, to calculate C(max) (ng/mL), T(max) (h), AUC(0−t) (ng h/mL) and time for AUC (h). RESULTS: Four children with influenza A received oral oseltamivir, 2.35–3 mg/kg/dose. This dose range produced a target oseltamivir carboxylate plasma concentration in excess of the proposed 12-h target AUC of 3800 ng h/mL, selected from earlier studies to avert resistance. One patient developed GIT adverse event: dry retching. CONCLUSION: Oseltamivir was well tolerated at a dose of 2.35–3 mg/kg/dose twice a day in infants under the age of 1 year. In general agreement with earlier data, these doses produced a target oseltamivir carboxylate plasma exposure in excess of the proposed 12-h target exposure of AUC equal to 3800 ng h/mL in two patients. The limited plasma concentration data in the remaining two patients were not inconsistent with the target exposure being reached.
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spelling pubmed-50114612016-09-22 Pharmacokinetics of oseltamivir in infants under the age of 1 year Dixit, Rashmi Matthews, Slade Khandaker, Gulam Walker, Karen Festa, Marino Booy, Robert Clin Transl Med Research BACKGROUND: Oseltamivir is the only antiviral treatment recommended for influenza in young children over the age of 1 year. There is scant data on oseltamivir pharmacokinetics (PK) in infants <1 year. We set out to perform PK measurements in infants who received oseltamivir. METHODS: This study was a prospective, uncontrolled, open label evaluation of the pharmacokinetics of oseltamivir metabolism, safety of oseltamivir, viral clearance in infants <12 months diagnosed with influenza by nasopharyngeal influenza nucleic acid antigen test (NAAT). Blood levels of the prodrug oseltamivir and its active carboxylate were measured prior to a dose of oseltamivir and at 4 time points afterwards, to calculate C(max) (ng/mL), T(max) (h), AUC(0−t) (ng h/mL) and time for AUC (h). RESULTS: Four children with influenza A received oral oseltamivir, 2.35–3 mg/kg/dose. This dose range produced a target oseltamivir carboxylate plasma concentration in excess of the proposed 12-h target AUC of 3800 ng h/mL, selected from earlier studies to avert resistance. One patient developed GIT adverse event: dry retching. CONCLUSION: Oseltamivir was well tolerated at a dose of 2.35–3 mg/kg/dose twice a day in infants under the age of 1 year. In general agreement with earlier data, these doses produced a target oseltamivir carboxylate plasma exposure in excess of the proposed 12-h target exposure of AUC equal to 3800 ng h/mL in two patients. The limited plasma concentration data in the remaining two patients were not inconsistent with the target exposure being reached. Springer Berlin Heidelberg 2016-09-05 /pmc/articles/PMC5011461/ /pubmed/27596232 http://dx.doi.org/10.1186/s40169-016-0118-1 Text en © The Author(s) 2016 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
spellingShingle Research
Dixit, Rashmi
Matthews, Slade
Khandaker, Gulam
Walker, Karen
Festa, Marino
Booy, Robert
Pharmacokinetics of oseltamivir in infants under the age of 1 year
title Pharmacokinetics of oseltamivir in infants under the age of 1 year
title_full Pharmacokinetics of oseltamivir in infants under the age of 1 year
title_fullStr Pharmacokinetics of oseltamivir in infants under the age of 1 year
title_full_unstemmed Pharmacokinetics of oseltamivir in infants under the age of 1 year
title_short Pharmacokinetics of oseltamivir in infants under the age of 1 year
title_sort pharmacokinetics of oseltamivir in infants under the age of 1 year
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5011461/
https://www.ncbi.nlm.nih.gov/pubmed/27596232
http://dx.doi.org/10.1186/s40169-016-0118-1
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