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首页> 外文期刊>The Journal of Clinical Pharmacology: Official Journal of the American College of Clinical Pharmacology >Pharmacokinetics of montelukast in asthmatic patients 6 to 24 months old.
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Pharmacokinetics of montelukast in asthmatic patients 6 to 24 months old.

机译：孟鲁司特在6至24个月大的哮喘患者中的药代动力学。

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摘要

Montelukast is a cysteinyl leukotriene receptor antagonist approved for the treatment of asthma for those ages 1 year old to adult. The purpose of this study was to evaluate the pharmacokinetic comparability of a 4-mg dose of montelukast oral granules in patients > or = 6 to < 24 months old to the 10-mg approved dose in adults. This was an open-label study in 32 patients. Population pharmacokinetic parameters included estimates of AUC(pop), C(max), and t(max). Results were compared with estimates from adults (10-mg film-coated tablet [FCT]). Dose selection criteria were for the 95% confidence interval (CI) for the AUC(pop) estimate ratio (pediatric/adult 10 mg FCT) to be within comparability bounds of (0.5, 2.00). The AUC(pop) ratio and the 95% CI for children compared with adults were within the predefined comparability bounds. Observed plasma concentrations were also similar. Based on systemic exposure of montelukast, a 4-mg dose of montelukast appears appropriate for children as young as 6 months ofage.
机译：孟鲁司特是一种半胱氨酰白三烯受体拮抗剂，已被批准用于治疗1岁至成人的哮喘。这项研究的目的是评估4毫克剂量的孟鲁司特口服颗粒在大于或等于6至<24个月大的患者与成人的10毫克批准剂量之间的药代动力学可比性。这是一项针对32位患者的开放标签研究。群体药代动力学参数包括AUC（pop），C（max）和t（max）的估计值。将结果与成人的估计值进行比较（10毫克薄膜衣片[FCT]）。剂量选择标准的AUC（pop）估计比率（儿科/成人10 mg FCT）的95％置信区间（CI）在可比范围（0.5，2.00）之内。儿童与成人相比的AUC（pop）比率和95％CI在预定的可比性范围内。观察到的血浆浓度也相似。根据孟鲁司特的全身暴露，孟鲁司特4 mg剂量似乎适合6个月大的儿童。

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