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 in patients requiring a continuous, around-the-clock opioid analgesic for an extended period of time. Butrans is 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)

Warnings (label excerpt)

5 WARNINGS AND PRECAUTIONS Use with extreme caution in patients at risk of respiratory depression. (5.1 , 7.2) Use with caution in patients who are receiving other central nervous system (CNS) depressants. (5.2 , 7.2 , 12.2) Additive CNS effects are expected when used with alcohol, benzodiazepines, other opioids, or illicit drugs. (5.3 , 7.2) Avoid in patients with Long QT Syndrome, family history of Long QT Syndrome, or those taking Class IA or Class III antiarrhythmic medications. (5.4 , 12.2) Butrans may worsen increased intracranial pressure and obscure its signs, such as level of consciousness or pupillary signs. (5.5) Use with caution in patients at increased risk of hypotension and in patients in circulatory shock. (5.6 , 12.2) Ileus may occur. Monitor for decreased bowel motility. (5.16) Use with caution in patients with biliary tract disease, including acute pancreatitis. (5.16) 5.1 Respiratory Depression Respiratory depression is the chief hazard of Butrans. Respiratory depre…

Excerpts are shortened. Read the full label, and ask a pharmacist or prescriber about any medicine. Full label on DailyMed(opens in a new tab) For products sold in Canada, see the Health Canada Drug Product Database(opens in a new tab).