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Dosage and Administration

-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.

-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.

-For patients currently on tramadol IR, calculate the total 24-hr IR dose, and initiate ULTRAM ER at a dose rounded down to next lower 100 mg increment; then adjust the dose according to need and tolerance. See full prescribing information for instructions on conversion, titration, and maintenance of therapy.

-Do not abruptly discontinue ULTRAM ER in a physically-dependent patient

Side Effects

The most common side effects of tramadol include nausea, dizziness, dry mouth, indigestion, abdominal pain, vertigo, vomiting, constipation, drowsiness and headache. Compared to other opioids respiratory depression and constipation is considered less of a problem with tramadol.

CONTRAINDICATIONS

ULTRAM® should not be administered to patients who have previously demonstrated hypersensitivity to tramadol, any other component of this product or opioids. ULTRAM® is contraindicated in any situation where opioids are contraindicated, including acute intoxication with any of the following: alcohol, hypnotics, narcotics, centrally acting analgesics, opioids, or psychotropic drugs. ULTR AM® may worsen central nervous system and respiratory depression in these patients.

Should not be administered to 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

Hypersensitivity to tramadol

Concurrent use of monoamine oxidase inhibitors (MAOIs) or use within the last 14 days

 

WARNINGS

Seizure Risk Seizures have been reported in patients receiving ULTRAM within the recommended dosage range. Spontaneous post226 marketing reports indicate that seizure risk is increased with doses of ULTRAM above the recommended range. Concomitant use of ULTRAM increases the seizure risk in patients taking:

Selective serotonin reuptake inhibitors (SSRI antidepressants or anorectics), Tricyclic antidepressants (TCAs), and other tricyclic compounds (e.g., cyclobenzaprine, promethazine, etc.), or Opioids.

-Administration of ULTRAM may enhance the seizure risk in patients taking:

-MAO inhibitors (see also WARNINGS – Use with MAO Inhibitors),

-Neuroleptics, or Other drugs that reduce the seizure threshold. The risk of convulsions may also increase in patients with epilepsy, those with a history of seizures, or in patients with a recognized risk for seizure (such as head trauma, metabolic disorders, alcohol and drug withdrawal, CNS infections). In ULTRAM overdose, naloxone administration may increase the risk of seizure.

-Anaphylactoid Reactions Serious and rarely fatal anaphylactoid reactions have been reported in patients receiving therapy with ULTRAM. These reactions often occur following the first dose. Other reported reactions include pruritus, hives,bronchospasm, and angioedema. Patients with a history of anaphylactoid reactions to codeine and other opioids . More Info : WIKI

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