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ULTRAM ER is an opioid agonist indicated for the management of pain severe enough to require daily around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate . Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve ULTRAM ER for use in patients for whom alternative treatment options (e.g., nonopioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. ULTRAM ER is not indicated as an as-needed (prn) analgesic .
DOSAGE AND ADMINISTRATION
To be prescribed only by healthcare providers knowledgeable in use of potent opioids for management of chronic pain.
Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals.
Individualize dosing based on the severity of pain, patient response, prior analgesic experience, and risk factors for addiction, abuse, and misuse.
Do not exceed a daily dose of 300 mg tramadol. Do not use with other tramadol products.
For opioid-naïve and opioid non-tolerant patients, initiate ULTRAM ER at a dose of 100 mg once daily, then titrate up by 100 mg increments every 5 days according to need and tolerance.
For patients currently on tramadol IR, calculate total 24-hr IR dose, and initiate ULTRAM ER at a dose rounded down to next lower 100 mg increment; then adjust dose according to need and tolerance. See full prescribing information for instructions on conversion, titration, and maintenance of therapy. (2.2, 2.3) • Do not abruptly
Constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain, seizure. Call your healthcare provider if you have any of these symptoms and they are severe.
Children younger than 12 years of age.
Postoperative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy.
Significant respiratory depression
Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment
Known or suspected gastrointestinal obstruction, including paralytic ileus (4) • Hypersensitivity to tramadol
• Concurrent use of monoamine oxidase inhibitors (MAOIs) or use within the last 14 days.
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