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Tapentadol SR is an S8 scheduled (controlled) drug indicated for the management of moderate to severe chronic pain unresponsive to non-opioid analgesia. Tapentadol SR may be another option for people with chronic, severe disabling pain for whom non-opioid analgesics provide insufficient pain relief, and for whom a trial of opioids as an alternative is indicated. Addiction, Abuse, and Misuse: Tapentadol oral tablets or extended-release tablets expose users to risks of addiction, abuse, and misuse, which can lead to overdose. Assess patient’s risk before prescribing and monitor regularly for these behaviors and conditions. To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a Risk Evaluation and Mitigation Strategy for these products.

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