毒理性
母乳喂养期间的使用总结:由于在母乳喂养期间使用齐拉西酮的经验很少被发表,可能更倾向于使用其他抗精神病药物,特别是在哺乳新生儿或早产儿时。一个安全评分系统认为在母乳喂养期间可以谨慎使用齐拉西酮。在使用齐拉西酮的母亲进行母乳喂养的婴儿应该被监测是否有过度镇静、烦躁不安、喂养困难以及锥体外系症状,如颤抖和异常肌肉运动。
对哺乳婴儿的影响:一名妇女在怀孕和产后期间每天服用齐拉西酮40毫克和西酞普兰60毫克。她广泛进行母乳喂养,偶尔由其他人用配方奶喂养。在6个月大时,儿科医生发现婴儿健康,生长和发育正常。
在国家非典型抗精神病药物怀孕登记处登记的患者中,有576名在母乳喂养期间服用第二代抗精神病药物的患者与未接受第二代抗精神病药物治疗的818名母乳喂养患者进行了比较。在服用第二代抗精神病药物的患者中,有60.4%的人服用了多种精神药物。在回顾儿科病历时,暴露于第二代抗精神病药物单药治疗或多药治疗的婴儿并未发现不良影响。没有报告服用齐拉西酮的妇女数量。
对泌乳和母乳的影响:在齐拉西酮治疗期间发生了催乳素升高,并且报告了通常发生在青春期的乳汁分泌过多。然而,催乳素升高可能比吩噻嗪类药物更短暂且程度较轻。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。
在国家非典型抗精神病药物怀孕登记处登记的患者中,有576名在母乳喂养期间服用第二代抗精神病药物的患者与主要诊断为重性抑郁障碍和焦虑障碍的818名母乳喂养患者进行了比较,这些患者通常使用SSRI或SNRI类抗抑郁药治疗,但不使用第二代抗精神病药物。在服用第二代抗精神病药物的妇女中,有60.4%的人服用了多种精神药物,而在对照组中这一比例为24.4%。在服用第二代抗精神病药物的妇女中,有59.3%的人报告“曾经母乳喂养”,而对照组的这一比例为88.2%。在产后3个月,服用第二代抗精神病药物的妇女中有23%的人进行纯母乳喂养,而对照组的这一比例为47%。没有报告服用齐拉西酮的妇女数量。
◉ Summary of Use during Lactation:Because there is little published experience with ziprasidone during breastfeeding, other antipsychotic agents may be preferred, especially while nursing a newborn or preterm infant. A safety scoring system finds ziprasidone possible to use cautiously during breastfeeding. Infants breastfed during maternal use of ziprasidone should be monitored for excess sedation, irritability, poor feeding, and extrapyramidal symptoms, such as tremors and abnormal muscle movements.
◉ Effects in Breastfed Infants:A woman took ziprasidone 40 mg and citalopram 60 mg daily throughout pregnancy and postpartum. She breastfed extensively, except for occasional formula feedings by others. At 6 months of age, a pediatrician found the infant to be healthy with normal growth and development.
Patients enlisted in the National Pregnancy Registry for Atypical Antipsychotics who were taking a second-generation antipsychotic drug while breastfeeding (n = 576) were compared to control breastfeeding patients who were not treated with a second-generation antipsychotic (n = 818). Of the patients who were taking a second-generation antipsychotic drug, 60.4% were on more than one psychotropic. A review of the pediatric medical records, no adverse effects were noted among infants exposed or not exposed to second-generation antipsychotic monotherapy or to polytherapy. The number of women taking ziprasidone was not reported.
◉ Effects on Lactation and Breastmilk:Prolactin elevation has occurred during ziprasidone treatment, and galactorrhea has been reported, often in adolescents. However, prolactin elevation might be more transient and less severe than with phenothiazines. The prolactin level in a mother with established lactation may not affect her ability to breastfeed.
Patients enlisted in the National Pregnancy Registry for Atypical Antipsychotics who were taking a second-generation antipsychotic drug while breastfeeding (n = 576) were compared to control breastfeeding patients who had primarily diagnoses of major depressive disorder and anxiety disorders, most often treated with SSRI or SNRI antidepressants, but not with a second-generation antipsychotic (n = 818). Among women on a second-generation antipsychotic, 60.4% were on more than one psychotropic compared with 24.4% among women in the control group. Of the women on a second-generation antipsychotic, 59.3% reported “ever breastfeeding” compared to 88.2% of women in the control group. At 3 months postpartum, 23% of women on a second-generation antipsychotic were exclusively breastfeeding compared to 47% of women in the control group. The number of women taking ziprasidone was not reported.
来源:Drugs and Lactation Database (LactMed)