tapentadol hydrochloride

1 INDICATIONS AND USAGE NUCYNTA ER (tapentadol) is indicated for the management of: Severe and persistent pain in adults that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Severe and persistent neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. NUCYNTA ER is an opioid agonist indicated for the management of: severe and persistent pain in adults that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. ( 1 ) severe and persistent neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults that requires 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 NUCYNTA ER, 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 ) NUCYNTA ER is not indicated as an as-needed (prn) analgesic. ( 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 [see Warnings and Precautions (5.1) ] , reserve opioid analgesics, including NUCYNTA ER, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. NUCYNTA ER is not indicated as an as-needed (prn) analgesic.