毒理性
乳酸钠、钙、镁和钾羟酸是γ-羟基丁酸(GHB)的盐。GHB是一种内源性物质,通常在母乳中可以发现少量。大剂量的GHB曾被用作滥用物质。有母亲在治疗发作性睡病时服用乳酸钠,并成功哺乳婴儿。在典型的每晚两次剂量的治疗方案下,通常应该从第一次服药时开始到第二次服药后4到6小时不哺乳,白天可以继续哺乳。目前没有关于在哺乳期间滥用GHB作为药物的使用或安全性的信息。监测婴儿是否出现镇静、进食不良和体重增长不良的情况。
◉ 对哺乳婴儿的影响:一位妇女在怀孕和哺乳期间每天两次服用4.5克乳酸钠治疗发作性睡病和猝倒症。她哺乳了她的婴儿(哺乳的程度和时间未说明)。未报告婴儿出现不良反应。
一位患有发作性睡病的妇女在怀孕和产后期间每晚10点和凌晨2点各服用4克乳酸钠,以及每天服用20毫克氟西汀和5毫克西替利嗪。她在服用乳酸钠后4小时内不哺乳,除了在每次服用乳酸钠前泵取母乳或哺乳婴儿。婴儿在6个月大时开始引入固体食物,之前是纯母乳喂养或用母乳喂养。婴儿在2、4和6个月时进行了评估,使用的是年龄和阶段问卷,结果在正常范围内,婴儿的生长和儿科医生对婴儿的生长和发展的临床印象也是正常的。
◉ 对泌乳和母乳的影响:截至修订日期,未找到相关的已发布信息。
◉ Summary of Use during Lactation:Sodium, calcium, magnesium and potassium oxybate are salts of gamma-hydroxybutyric acid (GHB). GHB is an endogenous substance and low amounts are normally found in breastmilk. Large doses of GHB have been used as a substance of abuse. Infants have been successfully breastfed by mothers taking sodium oxybate therapeutically for narcolepsy. With the typical 2 doses per night treatment regimen, nursing should usually be withheld from the time of the first dose to 4 to 6 hours after the second dose and breastfeeding can be continued during the day. No information is available on the use or safety of GHB as a drug of abuse during breastfeeding. Monitor the infant for sedation, poor feeding and poor weight gain.
◉ Effects in Breastfed Infants:A woman was taking 4.5 grams of sodium oxybate twice daily (exact times not reported) for narcolepsy and cataplexy throughout pregnancy and lactation. She breastfed her infant (extent and times not stated). No adverse infant effects were reported.
A woman with narcolepsy took sodium oxybate 4 grams each night at 10 pm and 2 am as well as fluoxetine 20 mg and cetirizine 5 mg daily throughout pregnancy and postpartum. She breastfed her infant except for 4 hours after the 10 pm oxybate dose and 4 hours after the 2 am dose. She either pumped breastmilk or breastfed her infant just before each dose of oxybate. The infant was exclusively breastfed or breastmilk fed for 6 months when solids were introduced. The infant was evaluated at 2, 4 and 6 months with the Ages and Stages Questionnaires, which were withing the normal range as were the infant's growth and pediatrician's clinical impressions regarding the infant's growth and development.
◉ Effects on Lactation and Breastmilk:Relevant published information was not found as of the revision date.
来源:Drugs and Lactation Database (LactMed)