排泄该药进入乳汁,哺乳期妇女健康药物动力学。

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Korth-Bradley JM,公园V,沙龙餐厅年代,古尔力我,Matschke K, Gossart年代,弗莱克斯坦布赖森P L

排泄该药进入乳汁,哺乳期妇女健康药物动力学。

Antimicrob代理Chemother。2011年11月,55 (11):5200 - 4。doi: 10.1128 / AAC.00311-11。Epub 2011年9月6日。

PubMed ID

21896908 (在PubMed

]

文摘

该药,全球注册兽医抗剂,目前正在开发的治疗盘尾丝虫病的人类与世界卫生组织合作。本研究的目的是评估该药的药物动力学在哺乳期妇女健康,包括排泄到母乳。十二个女性,年龄在23岁到38年,体重54到79公斤,都5个多月产后,后被录取,他们计划让婴儿和知情同意的条款。一个8毫克,开放后剂量的口服药物消费标准的早餐。完整的牛奶收集了大约28天,和血浆样本收集了90天。该药浓度测定用荧光高效液相色谱法(HPLC)检测,验证范围为0.08 - 120 ng / ml。Noncompartmental药代动力学方法被用来发现以下结果:在等离子体浓度峰值(C (max)), 87 + / - 25 ng / ml;时间C (max) (t (max)) 4.18 + / - 1.59 h;末期消除半衰期(t (1/2)) 832 + / - 321 h;曲线下面积(AUC), 4046 + / - 1796 ng。 h/ml; apparent oral dose clearance (CL/F), 2.35 +/- 1.07 l/h; ratio of CL/F to the terminal-phase disposition rate constant, lambda(z) (Vlambda(z)/F), 2,526 +/- 772 liters; percentage of maternal dose excreted in milk, 0.701 +/- 0.299%; absolute amount excreted in milk, 0.056 +/- 0.024 mg; relative infant dose, 8.73 +/- 3.17% of maternal dose assuming complete absorption; clearance in milk (CL(milk)), 0.016 +/- 0.009 liter/h. Nine of 12 subjects reported adverse events, all of which were considered treatment emergent but not drug related and were mostly reported during the long outpatient period 8 to 90 days after dose administration. The most frequently reported adverse events were headache and nausea (n = 4), oropharyngeal pain (n = 2), rhinitis, viral pharyngitis, and viral upper respiratory tract infection (n = 2).

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