Buprenorphine / naloxone Pregnancy and Breastfeeding Warnings
Buprenorphine / naloxone Pregnancy Warnings
Postimplantation losses, acephalus, and omphacele have been reported with high doses in animal studies. High doses have also been associated with statistically nonsignificant skeletal abnormalities in animal studies. Dystocia has been reported in pregnant rats. There are no controlled data in human pregnancy. Buprenorphine use during pregnancy has been associated with neonatal withdrawal symptoms. Buprenorphine-naloxone should only be used during pregnancy if the potential benefit justifies the risk to the fetus. FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
FDA pregnancy category: C Potential benefit should outweigh the potential risk.
Buprenorphine / naloxone Breastfeeding Warnings
Use of buprenorphine-naloxone is not recommended. Excreted into human milk: Yes Excreted into animal milk: Yes Limited study data showed no adverse reactions in breastfed infants at prescribed doses.
Extradural buprenorphine was associated with decreased milk production and infant weight gain in a clinical trial (n=20). In animal studies, a lack of milk production was observed. The manufacturer recommends against breast-feeding during buprenorphine-naloxone therapy.
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