buprenorphine

FDA Drug Profile — buprenorphine transdermal system, Butrans, SUBLOCADE

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 )