Department of Pediatrics, Texas Tech University Health Sciences Center, Amarillo, Texas, USA.
Department of Obstetrics and Gynecology, Texas Tech University Health Sciences Center, Amarillo, Texas, USA.
Breastfeed Med. 2021 Oct;16(10):843-845. doi: 10.1089/bfm.2021.0074. Epub 2021 Apr 16.
Vortioxetine (Trintellix) is a serotonin modulator used in the treatment of major depressive disorder in adults. There are no data presently published on the transfer of vortioxetine into human breast milk. The present study determined the drug concentration-time profile of vortioxetine in milk samples collected from three lactating mothers, two consuming 10 mg once daily and one consuming 20 mg once daily. Milk levels were measured using liquid chromatography mass spectrometry. At a dose of 10 mg/day, the maximum concentration of vortioxetine in milk was 13.89 ng/mL. At a dose of 20 mg/day, the maximum concentration in milk was 52.32 ng/mL. The relative infant dose was calculated to be 1.1% for 10 mg dose and 1.7% for 20 mg dose. In these three cases, we found the levels of vortioxetine in breast milk to be low and dose proportional. However, both RID's for 10 and 20 mg doses (1.1% and 1.7%, respectively) fall below the 10% theoretical level of concern and no adverse effects were reported by the mothers. As this is a small patient sample, caution should be exercised until further studies report the safety profile of vortioxetine in breastfeeding infants.
文拉法辛（Trintellix）是一种用于治疗成人重度抑郁症的 5-羟色胺调节剂。目前尚未发表文拉法辛进入人乳的转移数据。本研究旨在确定三种哺乳期母亲的乳汁样本中文拉法辛的药物浓度-时间曲线，其中两名母亲每天服用 10mg，一名母亲每天服用 20mg。采用液相色谱-质谱法测量乳汁中的药物浓度。每天服用 10mg 时，乳汁中文拉法辛的最大浓度为 13.89ng/ml。每天服用 20mg 时，乳汁中的最大浓度为 52.32ng/ml。计算得出，10mg 剂量的婴儿相对剂量为 1.1%，20mg 剂量的婴儿相对剂量为 1.7%。在这三种情况下，我们发现母乳中文拉法辛的水平较低且与剂量成比例。然而，10mg 和 20mg 剂量的 RID（分别为 1.1%和 1.7%）均低于 10%的理论关注水平，且母亲未报告任何不良反应。由于这是一个小患者样本，应谨慎使用，直到进一步的研究报告文拉法辛在母乳喂养婴儿中的安全性概况。
