Butrans: US FDA label indications

Indications and usage (label excerpt)

1 INDICATIONS AND USAGE BUTRANS is indicated for the management of moderate to severe chronic pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. Limitations of Use BUTRANS is not for use: As an as-needed (prn) analgesic For pain that is mild or not expected to persist for an extended period of time For acute pain For postoperative pain unless the patient is already receiving chronic opioid therapy prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time BUTRANS is a partial opioid agonist product 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. ( 1 ) Limitations of Use BUTRANS is not for use: As an as-needed (prn) analgesic ( 1 ) For pain that is mild or not expected to persist for an extended period of time ( 1 ) For acute pain ( 1 ) For postoperative pain, unless the patient is already receiving chronic opioid therapy prior to surgery, or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time ( 1 )

Warnings (label excerpt)

5 WARNINGS AND PRECAUTIONS Elderly, cachectic, and debilitated patients, and patients with chronic pulmonary disease: Monitor closely because of increased risk of respiratory depression. ( 5.4 , 5.5 ) Interaction with CNS depressants, especially benzodiazepines: Consider dose reduction of one or both drugs because of additive effects. ( 5.6 , 7.2 , 7.3 ) Avoid in patients with Long QT Syndrome, family history of Long QT Syndrome, or those taking Class IA or Class III antiarrhythmic medications. ( 5.7 , 12.2 ) Hypotensive effects: Monitor during dose initiation and titration. ( 5.8 ) Patients with head injury or increased intracranial pressure: Monitor for sedation and respiratory depression and avoid use of BUTRANS in patients with impaired consciousness or coma susceptible to intracranial effects of CO 2 retention. ( 5.9 ) 5.1 Abuse Potential BUTRANS contains buprenorphine, a partial agonist at the mu opioid receptor and a Schedule III controlled substance. Buprenorphine can be abused…

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