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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

tem (CNS) depressants.  Additive CNS effects are expected when used with alcohol, benzodiazepines, other opioids, or illicit drugs.
  • QTc Prolongation: Avoid in patients with Long QT Syndrome, family history of Long QT Syndrome, or those taking Class IA or Class III antiarrhythmic medications.
  • Head Injury:  Butrans may worsen increased intracranial pressure and obscure its signs, such as level of consciousness or pupillary signs.
  • Hypotensive Effects: Butrans may cause severe hypotension.  Use with caution in patients at increased risk of hypotension and in patients in circulatory shock.
  • Application Site Skin Reactions: In rare cases, severe application site skin reactions with signs of marked inflammation including "burn," "discharge," and "vesicles" have occurred.
  • Anaphylactic/Allergic Reactions: Cases of acute and chronic hypersensitivity to buprenorphine have been reported both in clinical trials and in the post-marketing experience.
  • Use in Pancreatic/Biliary Tract Disease and Other Gastrointestinal Conditions: Use with caution in patients with biliary tract disease, including acute pancreatitis.  Ileus may occur.  Monitor for decreased bowel motility.

  • Adverse Event InformationThe most common adverse events (greater than or equal to 5%) reported by patients treated with Butrans in clinical trials were nausea, headache, application site pruritus, dizziness, constipation, somnolence, vomiting, application site erythema, dry mouth, and application site rash.  The most frequently occurring application site skin reactions were application site pruritus, erythema, rash and irritation.  In rare cases, severe application site skin reactions with signs of marked inflammation including "burn," "discharge," and "vesicles" have occurred.

    Butrans Transdermal System Dosages Three strengths of Butrans are commercially available by
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    SOURCE Purdue Pharma L.P.
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