奥司他韦
药代动力学
医学
加药
药理学
药效学
人口
分配量
耐受性
内科学
不利影响
2019年冠状病毒病(COVID-19)
疾病
环境卫生
传染病(医学专业)
作者
Mohamed Kamal,Edward P. Acosta,David W. Kimberlin,Leonid Gibiansky,Penelope Jester,Vis Niranjan,Barbara Rath,Barry Clinch,Pablo J. Sánchez,Kwabena Krow Ampofo,Richard J. Whitley,Craig R. Rayner
标识
DOI:10.1038/clpt.2014.120
摘要
Infants are at increased risk for morbidity and mortality due to influenza. Until recently, few data were available with which to optimize oseltamivir dosing in this high-risk population. Here, data for 133 infants were pooled from two prospective pharmacokinetic/pharmacodynamic safety studies to develop a population pharmacokinetic model. A three-compartment model with allometric scaling of all clearance and volume parameters described the disposition of oseltamivir and its carboxylate metabolite (OC). Weight dependence, OC clearance, and volume of distribution increased linearly with age. Analyses showed no association between OC exposure and viral clearance, the development of resistance (phenotypic/genotypic), normalization of body temperature, or safety endpoints. Pharmacokinetic bridging showed that a 3 mg/kg dose yielded acceptable OC exposure and good tolerability while minimizing the risk of underexposure and resistance/treatment failure. These pharmacological analyses formed the basis of the US Food and Drug Administration's recent approval of oseltamivir treatment for infants with influenza aged as young as 2 weeks. Clinical Pharmacology & Therapeutics (2014); 96 3, 380–389. advance online publication 25 June 2014. doi:10.1038/clpt.2014.120
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