	Black Box Warning information researched and published by: Joyce Generali, MS, RPh, FASHP Director of Drug Information Black Box Information Center jgenerali@blackboxrx.com

Oxycodone (Controlled Release)

Abuse liability similar to morphine
Indications for management of moderate to severe pain with around the clock dosing. Not intended for prn use.
Dosage forms: 80 mg and 160 mg tablets for use in opioid tolerant patients only. Respiratory depression reported when used in opioid-naļve patients
Swallow tablets whole. Do not crush , chew or break as rapid release results and absorption may result in potentially fatal dose of oxycodone.

MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA

Black Box data revised July 2001 (FDA Safety Alert Posted)

Black Box Added: Dear Health Professional Letter (July 2001)

FDA Talk Paper (July 2001)

Full Revised Label (July 2001)

Note: Products are listed by generic names. Combination products are not included as such. If a combination product contains a drug with a black box (BBx) warning (e.g. metformin/rosiglitazone), it will be found under the drug name with the BBx (metformin or rosiglitazone).

Disclaimer: This information presents a SUMMARY of Black Box data from product information labeling and does not address additional warnings, precautions, or other important safety data in the product insert. Patient care decisions SHOULD NOT be made without reviewing the most recent product information insert, which may be obtained from the manufacturer. This table may not be complete as it was prepared using product information from package inserts. It is periodically updated with supplemental information from FDA safety alerts, the FDA labeling announcements, and new drug approvals. Last update: 2/2/2010

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