毒理性
哺乳期使用概要:阿米舒必利进入母乳的量比其他药理上相似的药物要高。关于阿米舒必利的大部分信息是作为精神治疗药物持续口服使用。对于这些用途,可能更倾向于使用替代药物,特别是在哺乳新生儿或早产儿时。对于手术后恶心和呕吐的单次剂量,制造商建议在恢复哺乳前等待48小时;然而,由于半衰期为4到5小时,等待12到24小时应该足够避免大量药物进入母乳。
对哺乳婴儿的影响:一名13个月大的婴儿部分由一名正在服用阿米舒必利400毫克、氟伏沙明200毫克和硫唑嘌呤150毫克每日的母亲哺乳,并且该母亲正在使用尼古丁口香糖来戒烟。母亲服用阿米舒必利已有9天;其他药物的服用时长未说明。儿科检查发现婴儿发育良好。
一名长期患有精神分裂症的女性在怀孕的大部分期间和哺乳期间(具体程度未说明)接受了阿米舒必利400毫克和氯丙嗪5毫克的治疗。儿科医生对哺乳婴儿进行了13个月的随访,未发现不良反应,婴儿发育正常。
对泌乳和母乳的影响:阿米舒必利会增加血清催乳素水平,并可能比其他精神药物更频繁地导致乳汁分泌过多。在已建立泌乳的母亲中,催乳素水平可能不会影响她的哺乳能力。
◉ Summary of Use during Lactation:Excretion of amisulpride into breastmilk is higher than with other pharmacologically similar drugs. Most information on amisulpride is with continuous oral use as a psychotherapeutic agent. For these uses, an alternate drug may be preferred, especially while nursing a newborn or preterm infant. After a single dose for post-operative nausea and vomiting, the manufacturer suggests waiting 48 hours before resuming breastfeeding; however, with a half-life of 4 to 5 hours, a waiting period of 12 to 24 hours should be adequate to avoid large amounts being excreted into breastmilk.
◉ Effects in Breastfed Infants:A 13-month-old infant was partially breastfed by a mother who was taking amisulpride 400 mg, fluvoxamine 200 mg, and azathioprine 150 mg daily, and was using nicotine chewing gum for smoking cessation. The mother had been taking amisulpride for 9 days; the duration of the other medications was not stated. A pediatric examination found the infant to be developing well.
A woman with long-standing schizophrenia was treated with amisulpride 400 mg and haloperidol 5 mg daily throughout most of her pregnancy and during breastfeeding (extent not stated). Follow-up of the breastfed infant for 13 months by a pediatrician found no adverse effects and normal development of the infant.
◉ Effects on Lactation and Breastmilk:Amisulpride increases serum prolactin and may cause galactorrhea at a higher rate than other psychotropic drugs. The prolactin level in a mother with established lactation may not affect her ability to breastfeed.
来源:Drugs and Lactation Database (LactMed)