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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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Tapentadol comes as a tablet and an extended-release (long acting) tablet to take by mouth. The tablets are usually taken with or without food every 4 to 6 hours as needed. If you are taking tapentadol tablets, your doctor may tell you that you may take a second dose as soon as 1 hour after the first dose on your first day of treatment if needed to treat your pain. Do not take extra doses at any other time during your treatment and do not ever take extra doses of the extended-release tablets. The extended-release tablets are taken once every 12 hours. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take tapentadol exactly as directed.

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Tapentadol is typically started at a low dose and gradually increased until pain is under control. Dosage should be individualized based on pain severity, therapy response, prior treatment experience and risk factors of addiction, abuse and misuse. Immediate-release tapentadol tablets are typically prescribed with an initial dosage of 50 to 100 mg taken orally every four to six hours as needed for pain relief. Additional doses may be prescribed for the first day of use to achieve optimum pain relief. The maximum dosage for immediate-release tapentadol tablets is 700 mg on the first day and 600 mg on subsequent days. Extended-release tapentadol tablets are typically prescribed with an initial dosage of 50 mg taken twice per day. The maximum dosage of extended-release tapentadol tablets is 500 mg per day.

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