Tapentadol is an opioid analgesic prescribed to treat moderate to severe pain. Tapentadol works by changing the way the nervous system and brain respond to pain.
It is available in both immediate-release and extended-release oral tablets. Tapentadol extended-release can also be prescribed to treat severe neuropathic pain associated with diabetic peripheral neuropathy. Tapentadol may be prescribed when alternative pain treatments fail to provide any relief. Immediate-release tapentadol tablets are used to treat acute pain. Extended-release tapentadol tablets are prescribed to provide 24-hour chronic pain relief and should not be used on an as-needed basis for pain. Tapentadol works best if taken at the onset of pain; it may not work as well if pain levels are already high. Tapentadol should only be taken as prescribed.
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. Life-Threatening Respiratory Depression: Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. Accidental Ingestion:Accidental ingestion of tapentadol oral tablets or extended-release tablets, especially by children, can result in a fatal overdose of tapentadol.Neonatal Opioid Withdrawal SyndromeProlonged use of tapentadol oral tablets or extended-release tablets during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If prolonged opioid use is required in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
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. Dosage should be individualized to provide adequate pain relief yet minimize adverse reactions. If changing from immediate-release to extended-release tapentadol, the current daily dosage of immediate-release should be divided into two equal doses of extended-release and taken orally twice per day, 12 hours apart.
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.
Do not stop taking tapentadol without talking to your doctor. Your doctor will probably decrease your dose gradually. If you suddenly stop taking tapentadol, you may experience withdrawal symptoms such as restlessness; anxiety; irritability; teary eyes; yawning; chills; sweating; difficulty falling asleep or staying asleep; shivering; uncontrollable shaking of a part of your body; muscle, back, or joint pain; weakness; nausea; vomiting; diarrhea; stomach cramps; loss of appetite; runny nose, sneezing, or coughing; hair on your skin standing on end; fast breathing; fast heartbeat; widening of the pupils (black circles in the middle of the eyes); or hallucinations (seeing things or hearing voices that do not exist).
While you are taking tapentadol, you may be told to always have a rescue medication called naloxone available (e.g., home, office). Naloxone is used to reverse the life-threatening effects of an overdose. It works by blocking the effects of opiates to relieve dangerous symptoms caused by high levels of opiates in the blood. You will probably be unable to treat yourself if you experience an opiate overdose. You should make sure that your family members, caregivers, or the people who spend time with you know how to tell if you are experiencing an overdose, how to use naloxone, and what to do until emergency medical help arrives. Your doctor or pharmacist will show you and your family members how to use the medication. Ask your pharmacist for the instructions or visit the manufacturer's website to get the instructions. If someone sees that you are experiencing symptoms of an overdose, he or she should give you your first dose of naloxone, call 911 immediately, and stay with you and watch you closely until emergency medical help arrives. Your symptoms may return within a few minutes after you receive naloxone. If your symptoms return, the person should give you another dose of naloxone. Additional doses may be given every 2 to 3 minutes, if symptoms return before medical help arrives.