Is Nalbuphine safe while breastfeeding?

Effects on the breastfed infant

A study compared pain control in women give, morphine sulfate by intravenous patient-controlled analgesia (PCA) following cesarean section or a single dose of intramuscular dinalbuphine sebecate 150 mg followed by PCA with morphine sulfate. All women were also given mefenamic acid 500 mg four times daily and propacetamol as needed. The dinalbuphine group used a lower amount of morphine by PCA, although the difference was not statistically significant, and a significantly lower amount of propacetamol. No instances of respiratory suppression, urinary retention, constipation, vomiting, or skin rash were observed after breastfeeding in either group.[ 4 ]

Effects on milk supply

Nalbuphine can increase serum prolactin.[ 5 ] However, the prolactin level in a mother with established lactation may not affect her ability to breastfeed. A study compared women who received nalbuphine or butorphanol during labor (n = 26) to those who received no analgesia (n = 22). The time to effective breastfeeding was longer (46.5 minutes) in the analgesia group than in the no analgesia group (35.4 minutes).[ 6 ] A national survey of women and their infants from late pregnancy through 12 months postpartum compared the time of lactogenesis II in mothers who did and did not receive pain medication during labor. Categories of medication were spinal or epidural only, spinal or epidural plus another medication, and other pain medication only. Women who received medications from any of the categories had about twice the risk of having delayed lactogenesis II ( 72 hours) compared to women who received no labor pain medication.[ 7 ] A study compared pain control in women give, morphine sulfate by intravenous patient-controlled analgesia (PCA) following cesarean section or a single dose of intramuscular dinalbuphine sebecate 150 mg followed by PCA with morphine sulfate. All women were also given mefenamic acid 500 mg four times daily and propacetamol as needed. Within 4 days of the procedure, 67% of morphine-only and 72% of participants in the dinalbuphine sebecate group gave breastmilk, 17 (52%) participants in morphine-only and 20 (63%) in dinalbuphine group breastfed at least once during the assessment period, and 15% in the morphine-only and 9% in dinalbuphine group gave pumped breast milk via a baby bottle only. The time between cesarean section and feeding via a baby bottle or breastfeeding was shorter in the group who received dinalbuphine, 1 day vs 1.7 days.[ 4 ]

Levels in milk

In adults, nalbuphine has very poor oral bioavailability and is metabolized to inactive metabolites. Parenteral doses of 75 to 300 mcg/kg are used in infant and children. Nalbuphine sebecate is a nalbuphine prodrug that undergoes a prolonged release into the bloodstream where it is rapidly converted into nalbuphine. Maternal Levels. Seven women who were 3 to 7 days postpartum received a single 20 mg IM dose of nalbuphine. Milk samples were collected several times, beginning at 1 hour and finishing at 24 hours after the dose. The half-life of elimination from milk was about 8 hours. A reported peak milk level in one mother was about 25 mcg/L, and it occurred 1 hour after the dose. The average milk level over the 24 hour study period in all 7 mothers was about 5 mcg/L (range 1.5 to 20 mcg/L).[ 1 ] Using the peak level reported in this study, an exclusively breastfed infant would receive a dosage of 3.7 mcg/kg daily, equivalent to 1.1% of the maternal weight-adjusted dosage. Using the average milk level from this study, an exclusively breastfed infant would ingest 0.75 mcg/kg daily, equivalent to 0.2% of the maternal weight-adjusted dosage or 0.25 to 1% of the infant parenteral dosage. Eighteen women were administered nalbuphine 0.2 mg/kg intravenously every 4 hours (average 25.5 mcg/kg daily) for pain following cesarean section. Milk samples were collected every 3 hours during the second day of drug administration. Because of small milk volumes, only 32 samples from 14 of the women were collected. The average milk nalbuphine concentration was 42 mcg/L, and the average maximum milk concentration was 61 mcg/L. The authors estimated that a fully breastfed infant would receive an average of 7 mcg/kg daily which amounts to about 0.6% of the weight-adjusted maternal dosage.[ 2 ] Sixteen women who had undergone a cesarean section were administered one dose of 150 mg of nalbuphine sebecate intramuscularly and pooled milk samples were collected from each breast every 12 hours

Alternatives LactMed lists

• Acetaminophen
• Butorphanol
• Fentanyl
• Hydromorphone
• Ibuprofen
• Morphine