Label Changes for:

OxyContin (oxycodone hydrochloride) controlled-release tablets

September 2009

Changes have been made to the PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- September 2009

(included adding the 60-mg strength to opioid tolerance language throughout the label; i.e. Boxed Warning, Warning)

PRECAUTIONS

Drug-Drug Interactions
  • Oxycodone is metabolized in part by cytochrome P450 2D6 and cytochrome P450 3A4 and in theory can be affected by other drugs.
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