When a continuous, around-the-clock opioid analgesic is needed for an extended period of time.
WARNING: ABUSE POTENTIAL, LIFE-THREATENING RESPIRATORY DEPRESSION, ACCIDENTAL EXPOSURE, and INTERACTION WITH ALCOHOL
NUCYNTA® ER contains tapentadol, an opioid agonist and Schedule II controlled substance with an abuse liability similar to other opioid agonists, legal or illicit. Assess each patient’s risk for opioid abuse or addiction prior to prescribing NUCYNTA® ER. The risk for opioid abuse is increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depressive disorder). Routinely monitor all patients receiving NUCYNTA® ER for signs of misuse, abuse, and addiction during treatment.
Life-threatening Respiratory Depression
Respiratory depression, including fatal cases, may occur with use of NUCYNTA® ER, even when the drug has been used as recommended and not misused or abused. Proper dosing and titration are essential, and NUCYNTA® ER should only be prescribed by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain. Monitor for respiratory depression, especially during initiation of NUCYNTA® ER or following a dose increase. Instruct patients to swallow NUCYNTA® ER tablets whole. Crushing, dissolving, or chewing NUCYNTA® ER can cause rapid release and absorption of a potentially fatal dose of tapentadol.
Accidental ingestion of NUCYNTA® ER, especially in children, can result in a fatal overdose of tapentadol.
Interaction With Alcohol
The co-ingestion of alcohol with NUCYNTA® ER may result in an increase of plasma levels and potentially fatal overdose of tapentadol. Instruct patients not to consume alcoholic beverages or use prescription or nonprescription products that contain alcohol while on NUCYNTA® ER.