Summary of Use during Lactation

Piritramide is not approved for marketing in the United States by the U.S. Food and Drug Administration, but is available in other countries. Limited data indicate that the amounts of piritamide in colostrum is very low after use of intravenous piritamide by patient-controlled analgesia.

Maternal use of oral opioids during breastfeeding can cause infant drowsiness, which may progress to rare but severe central nervous system depression. Newborn infants seem to be particularly sensitive to the effects of even small dosages of narcotic analgesics. If piritramide is required by the mother of a newborn, it is not a reason to discontinue breastfeeding; however, once the mother's milk comes in, it is best to provide pain control with a nonnarcotic analgesic and limit maternal intake of piritramide to 2 to 3 days at a low dosage with close infant monitoring. If the baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness, a physician should be contacted immediately.

Drug Levels

Maternal Levels. Ten women who had received piritamide intravenously by patient-controlled analgesia during the first 48 hours following a cesarean section had drug concentrations measured in their colostrum. The timing of samples was not reported. Six of the women had concentration of piritamide below the lower limit of quantification (<30 mcg/L). Of the other 4 women, the highest concentration was 75 mcg/L.[1]

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

Relevant published information was not found as of the revision date.

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

References

1.

Van Eeckhaut A, Vanfleteren P, Van Schoors J, et al. Quantification of piritramide in human colostrum. J Clin Pharm Ther 2017;42:306-10. [PubMed: 28295465]

Substance Name

Piritramide

CAS Registry Number

302-41-0

Drug Class

Breast Feeding

Lactation

Milk, Human

Analgesics, Opioid

Narcotics