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Meperidine / promethazine Pregnancy and Breastfeeding Warnings

Brand names: Mepergan, Mepergan Fortis, Meprozine

Meperidine / promethazine Pregnancy Warnings

Neural tube defects (exencephaly and cranioschisis) have been reported in hamsters administered 1 dose of meperidine during a critical period of organogenesis at 2.6 and 4.4 times the total human daily dose of 400 mg. There are no controlled data in human pregnancy.

Chronic use of opioids may cause reduced fertility in male and females; it is unknown if these effects are reversible.

Benefit should outweigh risk

US FDA pregnancy category: Not formally assigned to a pregnancy category

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.
-Promethazine administered 2 weeks prior to delivery may inhibit platelet aggregation in the newborn.
-Neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression.

See references

Meperidine / promethazine Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Yes (meperidine); Unknown (promethazine)
Excreted in animal milk: Data not available (promethazine)

Comments:
-Promethazine can inhibit prolactin release and may interfere with lactation.
-Withdrawal symptoms may occur in breastfed infants when maternal administration of an opioid is stopped or when breast-feeding is stopped.

Phenothiazine derivatives are minimally excreted in breastmilk; specific data on excretion of promethazine is not available. A less potent histamine blocking is generally preferred in nursing mothers. Oral opioids during breastfeeding can cause infant drowsiness, CNS depression, and death. Once a mother's milk is in, it is best to provide pain control with a nonopioid analgesic.

See references

References for pregnancy information

  1. Product Information. Mepergan (meperidine-promethazine). Wyeth Laboratories. 2001;PROD.
  2. Product Information. Meperidine HCl-Promethazine HCl (meperidine-promethazine). ECI Pharmaceuticals LLC. 2004.

References for breastfeeding information

  1. Product Information. Mepergan (meperidine-promethazine). Wyeth Laboratories. 2001;PROD.
  2. Product Information. Meperidine HCl-Promethazine HCl (meperidine-promethazine). ECI Pharmaceuticals LLC. 2004.
  3. United States National Library of Medicine. Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT 2013.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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