毒理性
哺乳期使用总结:偶尔小剂量的羟嗪不会预期对哺乳婴儿产生任何不良影响。较大剂量或更长时间的使用可能会导致婴儿昏昏欲睡或其他影响,或者减少乳汁供应,特别是在与伪麻黄碱等拟交感神经药联合使用或哺乳尚未稳定时。在哺乳新生儿或早产儿时,首选其他药物。
对哺乳婴儿的影响:在一项电话随访研究中,母亲报告10%的暴露于各种抗组胺药的婴儿出现烦躁和肠绞痛症状,1.6%的婴儿出现嗜睡。所有反应均未需要医疗关注。
在1985年1月至2011年6月期间,法国报告的所有哺乳婴儿的不良反应由一个法国药物警戒中心汇编。在174份报告中,羟嗪被报告在8名婴儿中引起不良反应,并且是最常被认为是严重不良反应的主要嫌疑药物,主要是镇静。
对哺乳和乳汁的影响:相对高剂量的抗组胺药通过注射可以减少非哺乳期妇女和产后早期妇女的基础血清催乳素。然而,哺乳诱导的催乳素分泌不受产后母亲抗组胺药预处理的影响。尚未研究较低口服剂量的抗组胺药是否对血清催乳素有相同的影响,或者催乳素的效果是否对哺乳成功有任何影响。在已经建立哺乳的母亲中,催乳素水平可能不会影响她的哺乳能力。
一位5周大婴儿的哺乳母亲被诊断为双相情感障碍、恐慌发作和焦虑症。她开始服用羟嗪50毫克,不定时服用,持续3至5天,对乳汁产量没有影响。然后她开始不定时服用阿立哌唑5毫克。5天后,她报告乳汁产量减少,需要用配方奶粉补充。停用两种药物9天后,她的乳汁供应恢复正常。乳汁减少可能是由于药物引起的,最可能是阿立哌唑。
◉ Summary of Use during Lactation:Small occasional doses of hydroxyzine would not be expected to cause any adverse effects in breastfed infants. Larger doses or more prolonged use may cause drowsiness and other effects in the infant or decrease the milk supply, particularly in combination with a sympathomimetic such as pseudoephedrine or before lactation is well established. Other agents are preferred, especially while nursing a newborn or preterm infant.
◉ Effects in Breastfed Infants:In one telephone follow-up study, mothers reported irritability and colicky symptoms 10% of infants exposed to various antihistamines and drowsiness was reported in 1.6% of infants. None of the reactions required medical attention.
All adverse reactions in breastfed infants reported in France between January 1985 and June 2011 were compiled by a French pharmacovigilance center. Of 174 reports, hydroxyzine was reported to cause adverse reactions in 8 infants and to be one of the drugs most often suspected in serious adverse reactions, primarily sedation.
◉ Effects on Lactation and Breastmilk:Antihistamines in relatively high doses given by injection can decrease basal serum prolactin in nonlactating women and in early postpartum women However, suckling-induced prolactin secretion is not affected by antihistamine pretreatment of postpartum mothers. Whether lower oral doses of antihistamines have the same effect on serum prolactin or whether the effects on prolactin have any consequences on breastfeeding success have not been studied. The prolactin level in a mother with established lactation may not affect her ability to breastfeed.
The breastfeeding mother of a 5-week-old infant was diagnosed with bipolar disorder, panic attacks and anxiety disorder. She was started on hydroxyzine 50 mg at an unspecified interval and took it for 3 to 5 days with no effect on milk production. She was then started on aripiprazole 5 mg at an unspecified interval. After 5 days, she reported a decrease in milk production that required supplementation with formula. Nine days after stopping both drugs, her milk supply returned to normal. The decreased milk supply was possibly caused by the medications, with aripiprazole most likely.
来源:Drugs and Lactation Database (LactMed)