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Oxycodone Pregnancy and Breastfeeding Warnings

Oxycodone is also known as: Dazidox, ETH-Oxydose, Endocodone, M-Oxy, Oxaydo, Oxecta, OxyContin, OxyIR, Oxydose, Oxyfast, Percolone, Roxicodone, Roxicodone Intensol, RoxyBond, Xtampza ER

Medically reviewed on December 12, 2017

Oxycodone Pregnancy Warnings

Not recommended

AU TGA pregnancy category: C
US FDA pregnancy category: Not Assigned

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.

Opioid analgesics cross the placenta. The use of this drug during labor may cause respiratory depression in the newborn infant. 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.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

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.

See references

Oxycodone Breastfeeding Warnings

Maternal use of opioids during breastfeeding can cause infant drowsiness, central nervous system depression, and even death. Infant sedation is common with maternal use of this drug. Newborn infants are particularly sensitive to the effects of even small dosages of opioid analgesics. When possible, pain control should be with a non opioid analgesic. However, if needed, use should be limited to the immediate-release products with a maximum dosage of 30 mg per day. Infants should be monitored closely for drowsiness, adequate weight gain, and developmental milestones, especially younger, exclusively breastfed infants.

Not recommended unless benefits outweigh risks

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.

See references

References for pregnancy information

  1. "Product Information. Tylox (acetaminophen-oxycodone)." McNeil Pharmaceutical, Raritan, NJ.
  2. "Product Information. OxyContin (oxycodone)." Purdue Frederick Company, Norwalk, CT.
  3. Koren G, Pastuszak A, Ito S "Drugs in pregnancy." N Engl J Med 338 (1998): 1128-37
  4. Cerner Multum, Inc. "Australian Product Information." O 0
  5. "Product Information. Percocet (acetaminophen-oxycodone)." DuPont Pharmaceuticals, Wilmington, DE.
  6. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

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. Tylox (acetaminophen-oxycodone)." McNeil Pharmaceutical, Raritan, NJ.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. "Product Information. Percocet (acetaminophen-oxycodone)." DuPont Pharmaceuticals, Wilmington, DE.
  5. Cerner Multum, Inc. "Australian Product Information." O 0
  6. "Product Information. OxyContin (oxycodone)." Purdue Frederick Company, Norwalk, CT.

Further information

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

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