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Results of a Pivotal Phase 3 Efficacy and Safety Study for Butrans® (Buprenorphine) Transdermal System CIII Published in The Journal of Pain
Date:9/23/2011

ion, severe bronchial asthma, who have or are suspected of having paralytic ileus or known hypersensitivity to any of its components or the active ingredient, buprenorphine, as well as those who require opioid analgesia for a short period of time, for the management of post-operative pain, including use after out-patient or day surgeries, the management of mild pain, and the management of intermittent pain (e.g., use on an as needed basis).  

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
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SOURCE Purdue Pharma L.P.
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