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U.S. Department of Health and Human Services

Safety

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Combunox (Oxycodone HCl/ibuprofen) tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – September 2010

Summary View

 

WARNINGS

Pregnancy
  • Starting at 30 weeks gestation, Combunox, and other NSAIDs, should be avoided by pregnant women as premature closure of the ductus arteriosus may occur.

PRECAUTIONS

Carcinogenicity, Mutagenicity and Impairment of Fertility
  • Studies to evaluate the potential effects of the combination of oxycodone and ibuprofen on carcinogenicity and mutagenicity have not been conducted.
Pregnancy
  • Pregnancy Category C prior to 30 weeks gestation; Category D starting at 30 weeks gestation
  • Starting at 30 weeks gestation, Combunox, and other NSAIDS, should be avoided by pregnant women as premature closure of the ductus arteriosus in the fetus may occur. Combunox can cause fetal harm when administered to a pregnant woman starting at 30 weeks…