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Ibuprofen / oxycodone Pregnancy and Breastfeeding Warnings

Ibuprofen / oxycodone is also known as: Combunox

Medically reviewed on December 12, 2017

Ibuprofen / oxycodone Pregnancy Warnings

Animal studies have failed to reveal evidence of teratogenicity or developmental toxicity. 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 the specific opioid 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. NSAID use may be associated with a reversible delay in ovulation.

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 D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Not recommended during last trimester of pregnancy
-Prior to 30 weeks gestation: Use only if potential benefit justifies potential risk to the fetus

US FDA pregnancy category: C (prior to 30 weeks gestation)
US FDA pregnancy category: D (starting at 30 weeks gestation)

Comments:
-Avoid use during third trimester as it may cause premature closure of the ductus arteriosus.
-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 during labor for signs of excess sedation and respiratory depression.

See references

Ibuprofen / oxycodone Breastfeeding Warnings

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 doses of narcotic analgesics. Ibuprofen use may be considered acceptable in nursing mothers; however, according to some manufacturers, use is not recommended. Limited published reports indicate ibuprofen is present in human milk at relative infant doses of 0.06% to 0.6% of the maternal weight-adjusted daily dose. When considering risk versus benefit, the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug.

Benefit should outweigh risk

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. Ibuprofen-Oxycodone Hydrochloride (ibuprofen-oxycodone)." Actavis U.S. (Alpharma USPD), Owings Mills, MD.

References for breastfeeding information

  1. "Product Information. Ibuprofen-Oxycodone Hydrochloride (ibuprofen-oxycodone)." Actavis U.S. (Alpharma USPD), Owings Mills, MD.

Further information

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

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