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Purdue Pharma L.P. to Present Data From Clinical Program for Butrans™ (buprenorphine) Transdermal System CIII at PAINWeek® 2010
Date:9/9/2010

require 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).  

Three strengths of Butrans will be available: 5, 10, and 20 mcg/hour; each single transdermal system is intended to be worn for seven days.  Do 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 released from the system may result in overdose and death.

Warnings and Precautions

  • Use with extreme caution in patients at risk of respiratory depression.
  • Use with caution in patients who are receiving other central nervous system (CNS) depressants.
  • Additive CNS effects are expected when used with alcohol, benzodiazepines, other opioids, or illicit drugs.
  • Avoid in patients with Long QT Syndrome, a family history of Long QT Syndrome, or those taking Class IA or Class III antiarrhythmic medications.
  • Butrans may worsen increased intracranial pressure and obscure its signs, such as level of consciousness or pupillary signs.
  • Use with caution in patients at increased risk of hypotension and in patients in circulatory shock.
  • Ileus may occur; monitor for decreased bowel motility.
  • Use with caution in patients with biliary tract disease, including acute pancreatitis.

    • Clinical Trial Experience The efficacy of Butrans has been evaluated in four 12-week double-blind, controlled clinical trials in opioid-naive and opioid-experienced patients with moderate to severe chronic low back pain or osteoarthritis using pain scores as the primary efficacy variable.  Two studies in low back pain (described below) demonstrated efficacy while one study in low back pain failed to s
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    SOURCE Purdue Pharma L.P.
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