毒理性
◉ 母乳喂养期间使用总结:醋酸赛戈斯特龙在美国以复方阴道避孕环(Annovera)的形式提供,该环释放醋酸赛戈斯特龙和乙炔雌二醇。目前没有关于在哺乳期间使用该产品的信息;然而,赛戈斯特龙口服生物利用度低,因此哺乳婴儿对赛戈斯特龙的全身暴露将最小化。在哺乳期间不需要特别的预防措施。
根据现有证据,美国的专家意见认为,由于凝血风险,不应在产后3周前使用复方避孕产品。在产后3周到6个月之间,使用该方法的好处通常超过了理论上的或已证实的风险,尽管对哺乳无影响的证据不足,且不包括早产或患病婴儿。产后6个月后,可以使用复方避孕药,包括口服片剂、透皮贴剂和阴道环,但如果将继续哺乳,则更推荐仅含孕激素的方法。世界卫生组织的指南更为严格,指出在哺乳母亲中,不应在产后42天前使用复方口服避孕药,在产后6周到6个月之间,使用该方法的不利因素通常超过了有利因素。Annovera的制造商建议在停止哺乳之前使用其他形式的避孕。
◉ 对哺乳婴儿的影响:截至修订日期,没有找到关于醋酸赛戈斯特龙和乙炔雌二醇阴道插入物的相关已发布信息。关于使用醋酸赛戈斯特龙植入剂的研究发现,对生长和发育没有不良影响。
◉ 对泌乳和母乳的影响:截至修订日期,没有找到相关已发布信息。
◉ Summary of Use during Lactation:Segesterone acetate is available in the United States in a combination contraceptive vaginal ring (Annovera) that releases segesterone acetate and ethinyl estradiol. No information is available on the use of this product during breastfeeding; however, segesterone is poorly bioavailable orally, so systemic exposure to segesterone in breastfed infants will be minimal. No special precautions are necessary during breastfeeding.
Based on the available evidence, expert opinion in the United States holds that because of the clotting risk, combination contraceptive products should not be used before 3 weeks postpartum. Between 3 weeks and 6 months postpartum, the advantages of using the method generally outweigh the theoretical or proven risks, although the evidence of lack of effect on lactation is poor and does not include preterm or ill infants. After 6 months postpartum, combination contraceptives, including oral tablets, the transdermal patch and vaginal ring, can be used, but progestin-only methods are preferred if breastfeeding will be continued. World Health Organization guidelines are more restrictive, stating that combined oral contraceptives should not be used in nursing mothers before 42 days postpartum and the disadvantages of using the method generally outweigh the advantages between 6 weeks and 6 months postpartum. The manufacturer of Annovera recommends that another form of contraception should be used until breastfeeding is discontinued.
◉ Effects in Breastfed Infants:Relevant published information on segesterone acetate and ethinylestradiol vaginal insert was not found as of the revision date. Studies on the use of segesterone acetate implants have found no adverse effects on growth and development.
◉ Effects on Lactation and Breastmilk:Relevant published information was not found as of the revision date.
来源:Drugs and Lactation Database (LactMed)