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(See Managing Opiate Therapy for Acute Pain under Dosage and Administration.) Optimize concomitant use of other appropriate therapies. Use smallest effective dosage for shortest possible duration since long-term opiate use often begins with treatment of acute pain. In symptomatic treatment of acute pain, reserve opiate analgesics for pain resulting from severe injuries, severe medical conditions, or surgical procedures, or when nonopiate alternatives for relieving pain and restoring function are expected to be ineffective or are contraindicated. Tramadol/acetaminophen tablets: Short-term (≤5 days) management of acute pain that is severe enough to require an opiate analgesic and for which alternative treatment options (e.g., nonopiate analgesics) have not been, or are not expected to be, adequate or tolerated.Īmerican College of Rheumatology (ACR) states tramadol can be considered in patients with osteoarthritis in whom NSAIAs are contraindicated (e.g., those with renal impairment) or in whom acetaminophen or NSAIAs have not produced an adequate response. Efficacy established in 2 studies in patients with moderate to moderately severe chronic pain associated with osteoarthritis several other studies failed to provide adequate evidence of efficacy. Efficacy established in patients with moderately severe acute or chronic pain, including postoperative, gynecologic, obstetric, and cancer pain.Įxtended-release tablets or capsules: Management of pain that is severe enough to require long-term, daily, around-the-clock use of an opiate analgesic and for which alternative treatment options (e.g., nonopiate analgesics, immediate-release opiates) are inadequate or not tolerated not indicated for as-needed (“prn”) use. Uses for traMADol PainĬonventional tablets: Management of pain that is severe enough to require an opiate analgesic and for which alternative treatment options (e.g., nonopiate analgesics) have not been, or are not expected to be, adequate or tolerated.
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Synthetic opiate agonist and inhibitor of norepinephrine and serotonin uptake not an opium derivative or a semisynthetic derivative of morphine or thebaine. The REMS may apply to one or more preparations of tramadol and consists of the following: medication guide and elements to assure safe use. Risk Evaluation and Mitigation Strategy (REMS):įDA approved a REMS for tramadol to ensure that the benefits outweigh the risk. Reserve concomitant use of opiate analgesics and benzodiazepines or other CNS depressants for patients in whom alternative treatment options are inadequate use lowest effective dosages and shortest possible duration of concomitant therapy and monitor closely for respiratory depression and sedation. (See Interactions.)Ĭoncomitant Use with Benzodiazepines or Other CNS DepressantsĬoncomitant use of opiate agonists with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. (See Pregnancy under Cautions.)Ĭarefully consider the effects of initiation or discontinuance of CYP3A4 inhibitors, CYP3A4 inducers, or CYP2D6 inhibitors on the pharmacokinetics of tramadol and its active metabolite, M1. Advise women who require such therapy during pregnancy of this risk and ensure appropriate treatment will be available. Prolonged maternal use of opiates during pregnancy can result in neonatal withdrawal syndrome, which may be life-threatening if not recognized and treated. Patients must swallow extended-release tablets or capsules whole to avoid exposure to a potentially fatal dose.Īccidental ingestion, especially by a child, can result in a fatal overdose. (See Respiratory Depression under Cautions.) Monitor for respiratory depression, especially during initiation of therapy and following dosage increases. Serious, life-threatening, or fatal respiratory depression may occur. (See Addiction, Abuse, and Misuse under Cautions.) Assess each patient’s risk for addiction, abuse, and misuse before prescribing tramadol monitor all patients regularly for development of these behaviors or conditions. Risk of addiction, abuse, and misuse, which can lead to overdosage and death.