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Hydrocodone Pregnancy and Breastfeeding Warnings

Hydrocodone is also known as: Hysingla ER, Vantrela ER, Zohydro ER

Hydrocodone Pregnancy Warnings

May cause fetal harm; this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

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.
-Long-acting opioids should not be used during and immediately prior to labor, when short acting analgesics or other analgesic techniques are more appropriate.

Animal studies showed no fetal malformations in the offspring of mothers given 2 to 10 times an adult human dose. There are no adequate and well-controlled studies in pregnant women. Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome. There are no controlled data in human pregnancy.

Chronic opioid use may cause reduced fertility in males and females; it is unknown whether these effects on fertility are reversible.

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.

See references

Hydrocodone Breastfeeding Warnings

Maternal use of oral narcotics during breastfeeding can cause infant drowsiness, central nervous system depression, and even death. Newborns are particularly sensitive. Once a mother's milk comes in, it is best to provide pain control with a nonnarcotic analgesic. There are no studies describing drug levels of extended-release hydrocodone or its metabolites in breast milk. Hydrocodone is metabolized to 6 active metabolites including hydromorphone.

Use is not recommended and 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

Comments: Infants exposed to this drug through breast milk should be closely monitored for excess sedation and respiratory depression; withdrawal symptoms can occur when maternal administration of hydrocodone is stopped or breastfeeding is stopped.

See references

References for pregnancy information

  1. "Product Information. Zohydro ER (HYDROcodone)." Zogenix, Inc, San Diego, CA.
  2. "Product Information. Hysingla ER (HYDROcodone)." Purdue Pharma LP, Stamford, CT.

References for breastfeeding information

  1. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  2. "Product Information. Hysingla ER (HYDROcodone)." Purdue Pharma LP, Stamford, CT.
  3. "Product Information. Zohydro ER (HYDROcodone)." Zogenix, Inc, San Diego, CA.

Further information

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

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