毒理性
哺乳期使用总结：有限的信息表明，在哺乳期使用阿莫西林-克拉维酸期间，婴儿出现不良反应是不常见的，偶尔会出现不安、腹泻和皮疹。阿莫西林-克拉维酸在哺乳期母亲中是可以接受的。
对哺乳婴儿的影响：一项小型的、控制的、前瞻性研究让母亲监测她们的婴儿是否有不良反应的迹象（舌头起毛、喂养困难、大便频率和稠度的变化、尿布疹和皮肤疹）。还记录了体重变化和黄疸的发展。在这些参数上，对照组母亲的婴儿和服用阿莫西林-克拉维酸的14位母亲的婴儿之间没有发现统计学的差异。[2]
一项前瞻性、控制性研究询问了打电话咨询信息服务关于她们哺乳婴儿出现不良反应的母亲。母亲们正在服用阿莫西林或阿莫西林-克拉维酸。总体来说，在阿莫西林-克拉维酸组（22.3%）的婴儿中不良反应的发生率在统计学上高于阿莫西林组（7.5%），并且不良反应的几率与剂量有关。阿莫西林-克拉维酸的反应包括不安（8.9%）、腹泻（5.9%）、皮疹（5.9%）和便秘（1.5%），尽管没有单个不良反应在统计学上比阿莫西林组更常见。一名婴儿的母亲每天服用1.5克阿莫西林-克拉维酸，在母亲治疗期间婴儿的肝酶（AST和ALT）轻度升高，停药后10天恢复正常。[3]
一名从出生就开始哺乳的2个月大婴儿。他的母亲在怀孕期间服用了很多药物，但她不记得它们的身份。她患上了乳腺炎，并用阿莫西林-克拉维酸1克口服，每12小时一次，庆大霉素160毫克肌肉注射，每天一次。婴儿在两种药物的首剂后15分钟开始哺乳了10分钟。大约20分钟后，婴儿出现了全身性荨麻疹，30分钟后消失。几个小时后，婴儿再次哺乳，15分钟后荨麻疹再次出现，1小时后消失。在改用配方奶并且不再接触青霉素后，随访到16个月大时，反应没有再出现。不良反应很可能是由于母乳中的抗生素引起的。导致反应的药物无法确定，但很可能是阿莫西林-克拉维酸。[4]
对哺乳和母乳的影响：截至修订日期，没有找到相关的已发布信息。
◉ Summary of Use during Lactation:Limited information indicates that adverse reactions in infants are uncommon during the use of amoxicillin-clavulanic acid during nursing, with restlessness, diarrhea and rash occurring occasionally. Amoxicillin-clavulanic acid is acceptable in nursing mothers.
◉ Effects in Breastfed Infants:A small, controlled, prospective study had mothers monitor their infants for signs of adverse effects (furring of the tongue, feeding difficulties, changes in stool frequency and consistency, diaper rash, and skin rash). Weight change and the development of jaundice were also recorded. No statistical differences in these parameters were found between the infants of the control mothers and those of the 14 mothers taking amoxicillin-clavulanate.[2]
A prospective, controlled study asked mothers who called an information service about adverse reactions experience by their breastfed infants. Mothers were taking either amoxicillin or amoxicillin-clavulanic acid. Overall, adverse reactions in the infants were statistically more frequent in the amoxicillin-clavulanic acid group (22.3%) than in the amoxicillin group (7.5%) and the rate of adverse effects was dose-related. Amoxicillin-clavulanate reactions consisted of restlessness (8.9%), diarrhea (5.9%), rash (5.9%), and constipation (1.5%), although no single adverse effect was statistically more frequent than in the amoxicillin group. One infant whose mother was taking 1.5 g daily of amoxicillin-clavulanic acid developed mildly elevated liver enzymes (AST and ALT) during maternal therapy that returned to normal 10 days after discontinuation of the drug.[3]
A 2-month-old infant breastfed since birth. His mother had taken many medications during pregnancy, but she did not recall their identity. She developed mastitis and was treated with amoxicillin-clavulanic acid 1 gram orally every 12 hours and gentamicin 160 mg intramuscularly once daily. The infant was breastfed for 10 minutes starting 15 minutes after the first dose of both drugs. About 20 minutes later, the infant developed a generalized urticaria which disappeared after 30 minutes. A few hours later, the infant breastfed again and the urticaria reappeared after 15 minutes and disappeared after an hour. After switching to formula feeding and no further infant exposure to penicillins, the reaction did not reappear with follow-up to 16 months of age. The adverse reaction was probably caused by the antibiotics in breastmilk. The drug that caused the reaction cannot be determined, but it was most likely the amoxicillin-clavulanic acid.[4]
◉ Effects on Lactation and Breastmilk:Relevant published information was not found as of the revision date.
来源:Drugs and Lactation Database (LactMed)
