Buprenorphine Pregnancy and Breastfeeding Warnings

Buprenorphine is also known as: Buprenex, Butrans, Subutex

Buprenorphine Pregnancy Warnings

Animal studies have failed to reveal evidence of teratogenicity; however, use of buprenorphine has been associated with difficult parturition and fetotoxicity, including pre- and postimplantation loss and decreased postnatal survival in animals. There are no controlled data in human pregnancy. AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details. US 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.

AU: Use is contraindicated UK and US: This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus AU TGA pregnancy category: C US FDA pregnancy category: C Comments: Prolonged use of opioids during pregnancy for medical or non-medical reasons can result in physical dependence in the neonate. Women should be advised of the risk of neonatal opioid withdrawal and ensure that appropriate treatment will be available.

Buprenorphine Breastfeeding Warnings

Low levels of this drug are found in breast milk; the estimated maximum intake of an exclusively breastfed infant would be 2.4% of the maternal weight-adjusted dosage. There are numerous reports of breast fed infants of mothers in abstinence programs who have shown no adverse effects. Infants should be monitored for drowsiness, adequate weight gain, and developmental milestones. Women who received this drug for opiate abuse during pregnancy and are stable should be encouraged to breastfeed their infants postpartum, unless there is another contraindication. The amount of drug in breast milk may not be sufficient to prevent neonatal withdrawal and treatment of infant for neonatal abstinence syndrome (NAS) may be required. If breastfeeding is stopped abruptly, observe for signs and symptoms of opioid withdrawal in the infant.

AU: Use is contraindicated UK and US: Benefit should outweigh risk Excreted into human milk: Yes Comments: This drug has been used without apparent harmful effects in the nursing infant.

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