毒理性
◉ 母乳喂养期间使用总结:有限的信息表明,母亲服用尼夫特莫克斯的剂量高达每日15毫克/千克不会对哺乳婴儿造成任何严重的不良影响。通过母乳水平和计算机模拟发现,仅通过母乳喂养的婴儿所接受的剂量远低于用于治疗新生儿查加斯病的剂量。其他作者认为,在使用尼夫特莫克斯期间,母乳喂养并非禁忌。
◉ 对哺乳婴儿的影响:在刚果民主共和国,对一组33名正在服用尼夫特莫克斯的住院母亲哺乳的婴儿进行了随访(哺乳程度未说明)。30位母亲服用了完整的30剂口服尼夫特莫克斯,每日15毫克/千克,并且所有人都接受了为期7天的14剂静脉注射的依氟鸟氨酸,剂量为每日400毫克/千克,用于治疗人类非洲锥虫病(睡眠病)。哺乳母亲还服用了平均4种其他同时使用的药物,包括阿莫西林、环丙沙星、甲硝唑、甲氧苄啶-磺胺甲恶唑、阿司匹林和双氯芬酸(每种1名患者);氢化可的松、异丙嗪和奎宁(每种2名患者);左旋咪唑(6名患者);磺胺多辛-乙胺嘧啶(8名患者);氨基比林(13名患者);对乙酰氨基酚(16名患者);以及甲苯达唑(17名患者)。在哺乳婴儿中没有报告任何严重的不良事件。
◉ 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:Limited information indicates that maternal doses of nifurtimox up to 15 mg/kg daily produce do not cause any adverse serious effects in breastfed infants. Breastmilk levels and a computer simulation found that the dose that an exclusively breastfed infant would receive through breastmilk would be much less than the dose given to treat Chagas disease in newborn infants. Other authors consider that breastfeeding is not contraindicated during the use of nifurtimox.
◉ Effects in Breastfed Infants:A cohort of 33 infants who were breastfed (extent not stated) by hospitalized mothers taking nifurtimox was followed in the Democratic Republic of the Congo. Thirty mothers took a full course of 30 doses of oral nifurtimox 15 mg/kg daily and all received 14 doses of intravenous eflornithine 400 mg/kg daily for 7 days for human African trypanosomiasis. (sleeping sickness). Nursing mothers also took a median of 4 other concomitant medications, including amoxicillin, ciprofloxacin, metronidazole, trimethoprim-sulfamethoxazole, aspirin, and diclofenac (1 patient each); hydrocortisone, promethazine and quinine (2 patients each); levamisole (6 patients); sulfadoxine-pyrimethamine (8 patients); dipyrone (13 patients); acetaminophen (16 patients); and mebendazole (17 patients). No serious adverse events were reported in any of the breastfed infants.
◉ Effects on Lactation and Breastmilk:Relevant published information was not found as of the revision date.
来源:Drugs and Lactation Database (LactMed)