buprenorphine
Drug Details
- Generic Name
- buprenorphine
- Brand Names
- buprenorphine transdermal system, Butrans, SUBLOCADE
- Application Number
- ANDA207490
- Sponsor
- LTS Therapy Systems, LLC
- NDC Codes
- 12
- Dosage Forms
- PATCH, EXTENDED RELEASE, SOLUTION
- Routes
- TRANSDERMAL, SUBCUTANEOUS
- Active Ingredients
- BUPRENORPHINE
Indications and Usage
1 INDICATIONS AND USAGE Buprenorphine transdermal system is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate release opioids. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions ( 5.1 )] , reserve opioid analgesics, including buprenorphine transdermal system, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Buprenorphine transdermal system is not indicated as an as-needed (prn) analgesic Buprenorphine transdermal system is a partial opioid agonist indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. ( 1 ) Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including buprenorphine transdermal system, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. ( 1 , 5.1 ) Buprenorphine transdermal system is not indicated as an as-needed (prn) analgesic. ( 1 )