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ULTRAM is an opioid agonist indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve ULTRAM for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]:
• Have not been tolerated or are not expected to be tolerated
• Have not provided adequate analgesia, or are not expected to provide adequate analgesia.
- The most common incidence of treatment-emergent adverse events (≥15.0%) in patients from clinical trials were dizziness/vertigo, nausea, constipation, headache, somnolence, vomiting and pruritus.
- Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics: Avoid use with ULTRAM because they may reduce analgesic effect of ULTRAM or precipitate withdrawal symptoms.
• Serotonin Syndrome: May be life-threatening. Can occur with use of tramadol alone, with concomitant use of serotonergic drugs, with drugs that impair metabolism of serotonin or tramadol.
• Risk of Seizure: Can occur at the recommended dose of tramadol. Concomitant use with other drugs may increase seizure risk. Risk may increase in patients with epilepsy, a history of seizures, and in patients with a recognized risk for seizures.
• Risk of Suicide: Do not prescribe for suicidal or addiction-prone patients.
• Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off the opioid.
• Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients: Monitor closely, particularly during initiation and titration.
• Severe Hypotension: Monitor during dosage initiation and titration. Avoid use of ULTRAM in patients with circulatory shock.
• Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness: Monitor for sedation and respiratory depression. Avoid use of ULTRAM in patients with impaired consciousness or coma.
