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Acetaminophen / oxycodone Pregnancy and Breastfeeding Warnings

Acetaminophen / oxycodone is also known as: Endocet, Magnacet, Nalocet, Narvox, Oxycet, Percocet, Percocet 10/325, Percocet 10/650, Percocet 2.5/325, Percocet 5/325, Percocet 7.5/325, Percocet 7.5/500, Perloxx, Primlev, Roxicet, Roxilox, Tylox, Xartemis XR, Xolox

Medically reviewed on Dec 12, 2017

Acetaminophen / oxycodone Pregnancy Warnings

Prolonged use of opioids during pregnancy can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. The onset, duration, and severity of the condition will vary based on use (duration of use, timing, and amount of last maternal use) and rate of elimination in the newborn. There are no controlled data in human pregnancy.

Chronic use of opioids may cause reduced fertility; it is unknown whether these effects 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.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

Not recommended

US FDA pregnancy category: C (immediate-release); Not Assigned (extended-release)

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.
-Monitor neonates exposed to opioid analgesics for signs of excess sedation and respiratory depression.

See references

Acetaminophen / oxycodone Breastfeeding Warnings

Not recommended

Excreted into human milk: Yes

Comments:
-If used, monitor breastfed infants for excess sedation and respiratory depression.
-Withdrawal symptoms may occur in breastfed infants when maternal administration of an opioid is stopped or when breast-feeding is stopped.

Maternal use of narcotics during breastfeeding can cause infant drowsiness, central nervous system depression, and even death. Infant sedation is common with maternal use of oxycodone. Newborn infants are particularly sensitive to the effects of even small dosages of narcotic analgesics.

See references

References for pregnancy information

  1. "Product Information. Acetaminophen-Oxycodone Hydrochloride (acetaminophen-oxycodone)." Mallinckrodt Medical Inc, St. Louis, MO.
  2. "Product Information. Percocet 5/325 (acetaminophen-oxycodone)." Endo Laboratories LLC, Chadds Ford, PA.
  3. "Product Information. Xartemis XR (acetaminophen-oxycodone)." Mallinckrodt Medical Inc, St. Louis, MO.
  4. "Product Information. Percocet (acetaminophen-oxycodone)." DuPont Pharmaceuticals, Wilmington, DE.

References for breastfeeding information

  1. "Product Information. Percocet (acetaminophen-oxycodone)." DuPont Pharmaceuticals, Wilmington, DE.
  2. "Product Information. Xartemis XR (acetaminophen-oxycodone)." Mallinckrodt Medical Inc, St. Louis, MO.
  3. "Product Information. Percocet 5/325 (acetaminophen-oxycodone)." Endo Laboratories LLC, Chadds Ford, PA.
  4. "Product Information. Acetaminophen-Oxycodone Hydrochloride (acetaminophen-oxycodone)." Mallinckrodt Medical Inc, St. Louis, MO.
  5. 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 -]):

Further information

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

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