BUPRENORPHINE HYDROCHLORIDE (BELBUCA) Nursing Considerations

What is the generic name?

BUPRENORPHINE HYDROCHLORIDE

What is the Trade Name for BUPRENORPHINE HYDROCHLORIDE?

BELBUCA

What are the Indications for BUPRENORPHINE HYDROCHLORIDE?

• 1 INDICATIONS AND USAGE BELBUCA is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. BELBUCA buccal film contains buprenorphine, a partial opioid agonist. BELBUCA is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. ( 1 ) Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with long-acting opioid formulations, reserve BELBUCA for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. ( 1 ) BELBUCA is not indicated as an as-needed (prn) analgesic. ( 1 ) Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with long-acting opioid formulations [see Warnings and Precautions (5.1) ] , reserve BELBUCA for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. BELBUCA is not indicated as an as-needed (prn) analgesic.

References: https://open.fda.gov/