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Buprenorphine / naloxone Pregnancy and Breastfeeding Warnings

Buprenorphine / naloxone is also known as: Bunavail, Suboxone, Zubsolv

Buprenorphine / naloxone 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 losses 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 can result in physical dependence in the neonate; women should be advised of the risk of neonatal abstinence syndrome and ensure that appropriate treatment will be available. -Infants born of mothers receiving this drug during pregnancy should be closely monitored for symptoms of withdrawal (e.g., hypertonia, neonatal tremor, neonatal agitation, myoclonus, apnea, and bradycardia); onset has ranged from 1 to 8 days following birth with most cases occurring during day 1.

Buprenorphine / naloxone Breastfeeding Warnings

AU: Use is contraindicated UK: Use is not recommended US: Caution is advised Excreted into human milk: Yes (buprenorphine); Unknown (naloxone) Excreted into animal milk: Yes (buprenorphine); Unknown (naloxone) Comments: -Breastfed infants should be monitored closely for increased drowsiness and breathing difficulties. -In considering use of this drug during breastfeeding, the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for treatment and any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition.

Low levels of buprenorphine are found in breast milk. In a study of 7 women taking a median buprenorphine dose of 7 mg/day, the exclusively breastfed infant (assuming milk consumption of 150 mL/kg/day) would receive an estimated mean of 0.55 mcg/kg/day of buprenorphine and 0.29 mcg/kg/day of norbuprenorphine, constituting 0.38% and 0.18% of the maternal weight-adjusted dose, respectively. A second study in 6 lactating women receiving a median buprenorphine dose of 0.29 mg/kg/day 5 to 8 days after delivery yielded mean infant breast milk doses of 0.42 mcg/kg/day of buprenorphine and 0.33 mcg/kg/day of norbuprenorphine, equivalent to 0.2% and 0.12% of the maternal weigh-adjusted dose, respectively. There is no information regarding naloxone in breast milk; however, naloxone is not orally bioavailable so it is unlike to affect the breastfed infant. There are no human data on the use of this combination product in breastfeeding.

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