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OPANA ER contains oxymorphone, which is a morphine-like opioid agonist and a Schedule II controlled substance, with an abuse liability similar to other opioid analgesics. Oxymorphone can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing OPANA ER in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion.

OPANA ER is an extended-release oral formulation of oxymorphone indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.

OPANA ER is NOT intended for use as a prn analgesic.

OPANA ER TABLETS are to be swallowed whole and are not to be broken, chewed, dissolved, or crushed. Taking broken, chewed, dissolved, or crushed

OPANA ER TABLETS leads to rapid release and absorption of a potentially fatal dose of oxymorphone. Patients must not consume alcoholic beverages, or prescription or non-prescription medications containing alcohol, while on OPANA ER therapy. The co-ingestion of alcohol with OPANA ER may result in increased plasma levels and a potentially fatal overdose of oxymorphone.

INDICATIONS AND USAGE OPANA ER is indicated for the relief of moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time.

OPANA ER is not intended for use as a prn analgesic.

OPANA ER is not indicated for pain in the immediate post-operative period (12-24 hours following surgery) for patients not previously taking opioids because of the risk of oversedation and respiratory depression requiring reversal with opioid antagonists.

 OPANA ER is not indicated for pain in the post-operative period if the pain is mild or not expected to persist for an extended period of time.

CONTRAINDICATIONS OPANA ER is contraindicated in patients with a known hypersensitivity to oxymorphone hydrochloride or to any of the other ingredients in OPANA ER, or with known hypersensitivity to morphine analogs such as codeine. Oxymorphone ER Placebo % P a t i e n t s I m p r o v e d 0 10 20 30 40 50 60 70 80 90 100 Percent of Reduction/Improvement in Pain >0 ≥10 ≥20 ≥30 ≥40 ≥50 ≥60 ≥70 ≥80 ≥90 100 Page 11 OPANA ER is not indicated for pain in the immediate post-operative period (the first 12- 24 hours following surgery), or if the pain is mild, or not expected to persist for an extended period of time.

 OPANA ER is only indicated for post-operative use if the patient is already receiving the drug prior to surgery or if the post-operative pain is expected to be moderate or severe and persist for an extended period of time. Physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate. (See American Pain Society guidelines).

OPANA ER is contraindicated in any situation where opioids are contraindicated such as: patients with respiratory depression (in the absence of resuscitative equipment or in unmonitored settings), and in patients with acute or severe bronchial asthma or hypercarbia.

OPANA ER, like all opioids, is contraindicated in any patient who has or is suspected of having paralytic ileus. OPANA ER is contraindicated in patients with moderate and severe hepatic .

WARNINGS OPANA ER TABLETS are to be swallowed whole, and are not to be broken, chewed, crushed or dissolved. Taking broken, chewed, crushed or dissolved

OPANA ER TABLETS could lead to the rapid release and absorption of a potentially fatal dose of oxymorphone. Patients must not consume alcoholic beverages, or prescription or non-prescription medications containing alcohol, while on OPANA ER therapy. The co-ingestion of alcohol with OPANA ER may result in increased plasma levels and a potentially fatal overdose of oxymorphone.