NUCYNTA ER (tapentadol): US FDA label indications

Indications and usage (label excerpt)

1 INDICATIONS AND USAGE NUCYNTA ® ER (tapentadol) is indicated for the management of: moderate to severe chronic pain in adults neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults when a continuous, around-the-clock opioid analgesic is needed for an extended period of time [see Clinical Studies (14.1 , 14.2) ] . Limitations of Usage NUCYNTA ® ER is not intended for use: As an as-needed (prn) analgesic For pain that is mild or not expected to persist for an extended period of time For acute pain For postoperative pain unless the patient is already receiving chronic opioid therapy prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time. NUCYNTA ® ER is an opioid agonist indicated for the management of: moderate to severe chronic pain in adults ( 1 ) neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults ( 1 ) when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. Limitations of Use NUCYNTA ® ER is not for use:, As an as-needed (prn) analgesic ( 1 ), For pain that is mild or not expected to persist for an extended period of time ( 1 ), For acute pain ( 1 ), For postoperative pain, unless the patient is already receiving chronic opioid therapy prior to surgery, or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time. ( 1 )

Warnings (label excerpt)

5 WARNINGS AND PRECAUTIONS See Boxed WARNINGS Elderly, cachectic, and debilitated patients and patients with chronic pulmonary disease: Monitor closely because of increased risk of respiratory depression. ( 5.5 , 5.6 ) Interaction with CNS depressants: Consider dose reduction of one or both drugs because of additive effects. ( 5.7 , 7.3 ) Hypotensive effect: Monitor during dose initiation and titration. ( 5.8 ) Patients with head injury or increased intracranial pressure: Monitor for sedation and respiratory depression. Avoid use of NUCYNTA ® ER in patients with impaired consciousness or coma susceptible to intracranial effects of CO 2 retention. ( 5.9 ) Seizures: Use with caution in patients with a history of seizures. ( 5.10 ) Serotonin Syndrome: Potentially life-threatening condition could result from concomitant administration of drugs with serotonergic activity. ( 5.11 ) 5.1 Abuse Potential NUCYNTA ® ER contains tapentadol, an opioid agonist and a Schedule II controlled substance.…

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Trials whose interventions mention this drug

Canadian trials first. A match on the drug name does not mean the trial studied this specific product.