Document Detail

Oseltamivir pharmacokinetics and clinical experience in neonates and infants during an outbreak of H1N1 influenza A virus infection in a neonatal intensive care unit.
MedLine Citation:
PMID:  22564835     Owner:  NLM     Status:  MEDLINE    
Detailed oseltamivir pharmacokinetics have yet to be reported in neonates and infants; this group is at high risk of serious influenza-associated complications. Extrapolation of doses from older patients is complicated by rapid organ and drug-metabolizing enzyme maturation. A pharmacokinetic study has been conducted during an influenza A(H1N1) outbreak in a neonatal intensive care unit. Each included patient provided 4 samples for oseltamivir and 4 samples for its active metabolite oseltamivir carboxylate. A population pharmacokinetic model was developed with NONMEM. Allometric weight scaling and maturation functions were added a priori to scale for size and age based on literature values. Nine neonates and infants were recruited. A physiologically parameterized pharmacokinetic model predicted typical day 1 area under the curve (AUC(0-12)) values of 1,966 and 2,484 μg · h/liter for neonates and infants of ≤ 37 weeks of postmenstrual age (PMA) and >37 weeks of PMA treated with 1 mg/kg of body weight and 2 mg/kg, respectively. The corresponding steady-state AUC(0-12) values were 3,670 and 4,559 μg · h/liter. Premature neonates treated with 1 mg/kg and term babies treated with 2 mg/kg should have average oseltamivir carboxylate concentrations in a range similar to that for adults treated with 75 mg, corresponding to >200-fold above the half-maximal inhibitory concentration (IC(50)) value for influenza A(H1N1) from the start of therapy.
Joseph F Standing; Angela Nika; Vasileios Tsagris; Ioannis Kapetanakis; Helena C Maltezou; Dimitris A Kafetzis; Maria N Tsolia
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Publication Detail:
Type:  Clinical Trial; Journal Article; Research Support, Non-U.S. Gov't     Date:  2012-05-07
Journal Detail:
Title:  Antimicrobial agents and chemotherapy     Volume:  56     ISSN:  1098-6596     ISO Abbreviation:  Antimicrob. Agents Chemother.     Publication Date:  2012 Jul 
Date Detail:
Created Date:  2012-06-15     Completed Date:  2012-10-17     Revised Date:  2013-06-25    
Medline Journal Info:
Nlm Unique ID:  0315061     Medline TA:  Antimicrob Agents Chemother     Country:  United States    
Other Details:
Languages:  eng     Pagination:  3833-40     Citation Subset:  IM    
Infectious Diseases and Microbiology Unit, University College London, Institute of Child Health, London, United Kingdom.
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MeSH Terms
Antiviral Agents / pharmacokinetics*,  therapeutic use*
Disease Outbreaks
Infant, Newborn
Influenza A Virus, H1N1 Subtype / drug effects,  pathogenicity*
Influenza, Human / drug therapy*
Intensive Care Units
Oseltamivir / pharmacokinetics*,  therapeutic use*
Grant Support
G1002305//Medical Research Council
Reg. No./Substance:
0/Antiviral Agents; 0/Oseltamivir

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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