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Buprenorphine Pregnancy and Breastfeeding Warnings

Buprenorphine is also known as: Buprenex, Butrans, Subutex

Buprenorphine Pregnancy Warnings

Aromatase is the major enzyme that metabolizes buprenorphine in the human placenta.

Buprenorphine has been assigned to pregnancy category C by the FDA. Post-implantation losses, acephalus, omphacele, dystocia, and statistically insignificant skeletal abnormalities have been reported in animal studies. There are no controlled data in human pregnancy. Buprenorphine use during pregnancy has been associated with neonatal withdrawal symptoms. Buprenorphine should only be used during pregnancy if the potential benefit justifies the risk to the fetus.

Buprenorphine Breastfeeding Warnings

Buprenorphine and norbuprenorphine concentrations determined from ten random breast milk samples collected over four successive days from a lactating woman during buprenorphine maintenance therapy ranged from 1.0 to 14.7 ng/mL and 0.6 to 6.3 ng/mL, respectively. Drug exposure to the infant was considered to be low. In animal studies, a lack of milk production was observed.

Buprenorphine is excreted into human milk in low concentrations. The manufacturer recommends against breast-feeding during buprenorphine therapy.

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