OPANA ER- oxymorphone hydrochloride tablet, extended release
Lake Erie Medical DBA Quality Care Products LLC
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use OPANA® ER safely and effectively.  See full prescribing information for OPANA® ER. 
OPANA® ER (oxymorphone hydrochloride) Extended-Release tablets, for oral use, CII
Initial U.S. Approval: 1959
WARNING: ABUSE POTENTIAL, LIFE-THREATENING RESPIRATORY DEPRESSION, ACCIDENTAL EXPOSURE, and INTERACTION WITH ALCOHOL
See full prescribing information for complete boxed warning.
OPANA ER contains oxymorphone, a Schedule II controlled substance.  Monitor for signs of misuse, abuse, and addiction during OPANA ER therapy. (5.1, 9)
Fatal respiratory depression may occur, with highest risk at initiation and with dose increases.  Instruct patients on proper administration of OPANA ER tablets to reduce the risk. (5.2)
Accidental ingestion of OPANA ER can result in fatal overdose of oxymorphone, especially in children. (5.3)
Instruct patients not to consume alcoholic beverages or use prescription or non-prescription products containing alcohol while taking OPANA ER because of the risk of increased, and potentially fatal, plasma oxymorphone levels. (5.4)
RECENT MAJOR CHANGES
Boxed Warning                                             7/2012
Indications and Usage (1)                            7/2012
Dosage and Administration (2)                    7/2012
Contraindications (4)                                    7/2012
Warnings and Precautions (5)                     7/2012
INDICATIONS AND USAGE
OPANA ER is an opioid agonist indicated for the relief of moderate to severe pain in patients requiring continuous around-the-clock opioid treatment for an extended period of time. (1)
Limitations of Us
• OPANA ER is not for use:
-As an as-needed (prn) analgesic (1)
-For pain that is mild or not expected to persist for an extended period of time (1)
-For acute pain (1)
-For postoperative pain, unless the patient is already receiving chronic opioid therapy prior to surgery, or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time (1)
DOSAGE AND ADMINISTRATION
Individualize dosing based on patient’s prior analgesic treatment experience, and titrate as needed to provide adequate analgesia and minimize adverse reactions. (2.1 , 2.2)
Administer on an empty stomach, at least 1 hour prior to or 2 hours after eating. (2.1)
In