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Nalbuphine Pregnancy and Breastfeeding Warnings

Nalbuphine is also known as: Nubain

Nalbuphine Pregnancy Warnings

The placental transfer of nalbuphine is high, rapid, and variable with a maternal to fetal ratio ranging from 1:0.37 to 1:6. Fetal and neonatal adverse effects that have been reported following the administration of nalbuphine to the mother during labor include fetal bradycardia, respiratory depression at birth, apnea, cyanosis, and hypotonia. Some of these events may be life-threatening. Maternal administration of naloxone during labor has normalized these effects in some cases.

Nalbuphine has been assigned to pregnancy category B by the FDA. Nalbuphine has been assigned to pregnancy Risk Factor D by Briggs if used for prolonged periods or in high doses at term. Animal studies have failed to reveal evidence of teratogenicity, but have revealed decreased neonatal body weight and reduced neonatal survival rates with doses up to 4 times the recommended human dose. There are no controlled data in human pregnancy. Nalbuphine is only recommended for use during pregnancy when benefit outweighs risk.

Nalbuphine Breastfeeding Warnings

Nalbuphine is excreted in human milk in amounts that are considered clinically insignificant. The effects to the nursing infant are unknown. The manufacturer recommends that caution be used when administering nalbuphine to nursing women.

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