毒理性
◉ 母乳喂养期间使用总结：罗红霉素在美国未获得食品药品监督管理局的市场批准，但在其他国家可用。由于母乳中罗红霉素含量较低，预计不会对哺乳婴儿造成不良影响。监测婴儿可能出现的影响胃肠道菌群的情况，如腹泻、念珠菌病（鹅口疮、尿布疹）。未经证实的流行病学证据表明，在母乳喂养的前两周内，母亲使用大环内酯类抗生素可能会增加婴儿肥厚性幽门狭窄的风险，但也有人对此关系表示质疑。
◉ 对哺乳婴儿的影响：一项对诊断为婴儿肥厚性幽门狭窄的婴儿进行的队列研究发现，受影响的婴儿在出生后90天内，母亲使用大环内酯类抗生素的可能性是未受影响婴儿的2.3至3倍。对婴儿进行分层分析发现，女性婴儿的比值比为10，男性婴儿为2。所有受影响婴儿的母亲都哺乳了她们的婴儿。大多数大环内酯类药物的处方是红霉素，但19%是罗红霉素。然而，作者没有说明受影响婴儿的母亲使用了哪种大环内酯类药物。
一项在丹麦进行的15年数据回顾性数据库研究发现，在分娩后前13天内使用大环内酯类药物的母亲所生的婴儿，婴儿肥厚性幽门狭窄的风险增加了3.5倍，但之后的暴露没有增加风险。哺乳的婴儿比例未知，但可能很高。使用每种大环内酯类药物的母亲比例也没有报告。
一项比较了使用阿莫西林的母亲和服用大环内酯类抗生素的母亲的哺乳婴儿的研究发现，没有出现幽门狭窄的情况。在母乳中大环内酯类药物暴露的婴儿中，有67%暴露于罗红霉素。暴露于大环内酯类药物的婴儿中有12.7%出现了不良反应，这与阿莫西林暴露婴儿的发生率相似。反应包括皮疹、腹泻、食欲减退和嗜睡。
两项荟萃分析未能证明母亲在哺乳期间使用大环内酯类药物与婴儿肥厚性幽门狭窄之间存在关系。
◉ 对泌乳和母乳的影响：在冈比亚进行的一项双盲对照研究中，给鼻咽部携带金黄色葡萄球菌、肺炎链球菌或B组链球菌的妇女在分娩时单次给予2克阿奇霉素。接受阿奇霉素的妇女的乳汁样本中携带这些微生物的流行率为9.6%，而接受安慰剂的妇女为21.9%。母亲和婴儿在分娩后第6天的鼻咽部携带率也有所降低。
◉ Summary of Use during Lactation:Roxithromycin is not approved for marketing in the United States by the U.S. Food and Drug Administration, but is available in other countries. Because of the low levels of roxithromycin in breastmilk, it would not be expected to cause adverse effects in breastfed infants. Monitor the infant for possible effects on the gastrointestinal flora, such as diarrhea, candidiasis (thrush, diaper rash). Unconfirmed epidemiologic evidence indicates that the risk of infantile hypertrophic pyloric stenosis might be increased by maternal use of macrolide antibiotics during the first two weeks of breastfeeding, but others have questioned this relationship.
◉ Effects in Breastfed Infants:A cohort study of infants diagnosed with infantile hypertrophic pyloric stenosis found that affected infants were 2.3 to 3 times more likely to have a mother taking a macrolide antibiotic during the 90 days after delivery. Stratification of the infants found the odds ratio to be 10 for female infants and 2 for male infants. All of the mothers of affected infants nursed their infants. Most of the macrolide prescriptions were for erythromycin, but 19% were for roxithromycin. However, the authors did not state which macrolide was taken by the mothers of the affected infants.
A retrospective database study in Denmark of 15 years of data found a 3.5-fold increased risk of infantile hypertrophic pyloric stenosis in the infants of mothers who took a macrolide during the first 13 days postpartum, but not with later exposure. The proportion of infants who were breastfed was not known, but probably high. The proportion of women who took each macrolide was also not reported.
A study comparing the breastfed infants of mothers taking amoxicillin to those taking a macrolide antibiotic found no instances of pyloric stenosis. Sixty-seven percent of the infants exposed to a macrolide in breastmilk were exposed to roxithromycin. Adverse reactions occurred in 12.7% of the infants exposed to macrolides which was similar to the rate in amoxicillin-exposed infants. Reactions included rash, diarrhea, loss of appetite, and somnolence.
Two meta-analyses failed to demonstrate a relationship between maternal macrolide use during breastfeeding and infantile hypertrophic pyloric stenosis.
◉ Effects on Lactation and Breastmilk:In a double-blind, controlled study in Gambia, women who were nasopharyngeal carriers of Staphylococcus aureus, Streptococcus pneumoniae or group B streptococcus were given a single 2 gram dose of azithromycin during labor. Milk samples from women who received azithromycin had 9.6% prevalence of carriage of the organisms compared to 21.9% in women who received placebo. Nasopharyngeal carriage in mothers and infants was also reduced on day 6 postpartum.
来源:Drugs and Lactation Database (LactMed)
