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Purdue Pharma L.P. To Present Analysis Of Butrans® (buprenorphine) Transdermal System CIII Clinical Data At American Pain Society Annual Meeting
Date:5/18/2012

s who have or are suspected of having paralytic ileus. 

Butrans is also contraindicated in the management of: acute pain or in patients who require opioid analgesia for a short period of time, postoperative pain, mild pain, or intermittent pain (e.g., use on an as-needed basis [prn]).

The Full Prescribing Information for Butrans contains the following Boxed Warning:WARNING: IMPORTANCE OF PROPER PATIENT SELECTION, POTENTIAL FOR ABUSE, AND LIMITATIONS OF USEProper Patient SelectionButrans is a transdermal formulation of buprenorphine indicated for the management of moderate-to-severe chronic pain in patients requiring a continuous, around-the-clock opioid analgesic for an extended period of time.  Potential for Abuse Butrans contains buprenorphine which is a mu opioid partial agonist and a Schedule III controlled substance.  Butrans can be abused in a manner similar to other opioid agonists, legal or illicit.  Consider the abuse potential when prescribing or dispensing Butrans in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion. Persons at increased risk for opioid abuse include those with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression).  Assess patients for their clinical risks for opioid abuse or addiction prior to being prescribed opioids.  Routinely monitor all patients receiving opioids for signs of misuse, abuse and addiction.  Limitations of UseDo not exceed a dose of one 20 mcg/hour Butrans system due to the risk of QTc interval prolongation.  Avoid exposing the Butrans application site and surrounding area to direct external heat sources.  Temperature dependent increases in buprenorphine release from the system may result in overdose and death.Warnings and Precautions

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