University of Washington Department of Pharmacy, Seattle, WA 98195-7630, USA.
J Clin Pharmacol. 2010 Nov;50(11):1301-9. doi: 10.1177/0091270009358708. Epub 2010 Feb 9.
The objectives were to evaluate the time course for atenolol pharmacokinetics in lactating women postpartum and to quantify atenolol plasma concentrations in the women's 3- to 4-month-old nursing infants. Data were collected during 1 dosing interval from lactating women treated with atenolol for therapeutic reasons, at 2 to 4 weeks (n = 32), 3 to 4 months (n = 22), and 6 to 8 months (n = 17) postpartum. A single blood sample was collected from 15 nursing infants (3-4 months of age) of the mothers participating in the study. At 2 to 4 weeks, 3 to 4 months, and 6 to 8 months postpartum, atenolol infant doses, relative to the mother's weight-adjusted dose, were 14.6% ± 7.6%, 8.3% ± 5.2% and 5.9% ± 2.9%, respectively. Over this time, maternal atenolol pharmacokinetics did not change to a clinically significant extent. Atenolol concentrations were below assay quantification limits (<10 ng/mL) in the plasma of all 3- to 4-month-old nursing infants studied. These findings support the careful use of atenolol during breastfeeding, because in the vast majority of healthy, term infants, atenolol concentrations will be too low to be clinically relevant. Premature infants and those with kidney disease require further study. Infant exposure depends on maternal dose and decreases during the first 6 to 8 months postpartum.
目的是评估产后哺乳期妇女阿替洛尔药代动力学的时间过程,并定量分析哺乳期妇女 3 至 4 个月大的哺乳婴儿的阿替洛尔血浆浓度。研究期间,对因治疗原因接受阿替洛尔治疗的哺乳期妇女进行了 1 个给药间隔的数据收集,这些妇女分别在产后 2 至 4 周(n = 32)、3 至 4 个月(n = 22)和 6 至 8 个月(n = 17)。从参与研究的母亲中 15 名 3 至 4 个月大的哺乳婴儿中采集了单次血样。产后 2 至 4 周、3 至 4 个月和 6 至 8 个月时,婴儿的阿替洛尔剂量相对于母亲的体重调整剂量分别为 14.6% ± 7.6%、8.3% ± 5.2%和 5.9% ± 2.9%。在此期间,母亲的阿替洛尔药代动力学没有发生到有临床意义的变化。在所有研究的 3 至 4 个月大的哺乳婴儿的血浆中,阿替洛尔浓度均低于检测限(<10 ng/mL)。这些发现支持在母乳喂养期间谨慎使用阿替洛尔,因为在绝大多数健康的足月婴儿中,阿替洛尔浓度太低,不会产生临床相关影响。早产儿和患有肾脏疾病的婴儿需要进一步研究。婴儿的暴露量取决于母亲的剂量,且在产后 6 至 8 个月内逐渐减少。