Ultram Information

Ultram, a synthetic opioid, was approved for the treatment of moderate to moderately severe pain nearly nine years ago. In the first year after approval, the FDA received 83 reports of seizures among people taking this analgesic.

Tramadol HC1 (Ultram), a centrally acting analgesic, is approved for the management of moderate to moderately severe pain. Recommended dose is 50 to 100 mg every 4 to 6 hours as needed for relief of pain, not to exceed 400 mg/d. Dosage should not exceed 300 mg/d in patients over age 75.

In clinical studies, patients with such chronic conditions as low back pain, cancer, neuropathic pain, and orthopedic and joint conditions received an average daily dose of 250 mg of tramadol in divided doses. At this dose, tramadol produced analgesia comparable with five doses of acetaminophen (300 mg) with codeine phosphate (30 mg).

The most common side effects were dizziness/vertigo, nausea, constipation, headache, somnolence, and vomiting. Tramadol may increase the risk of seizures in patients with epilepsy and in those taking MAO inhibitors or neuroleptics.

Tramadol is thought to have two mechanisms of action. First, there are Mu, Kappa, and Delta opioid-receptor effects, with an active metabolite of tramadol having Mu specificity. Decreased serotonin and norepinephrine uptake may also contribute to tramadol's analgesic effect.

Laura H. Kahn, M.D., M.P.H., and colleagues at the Federal agency searched the FDAs database of adverse drug events and found that by July 31, 1996, 124 unduplicated seizure cases occurred within one day following the initial dose of Ultram.

This adverse effect occurred at recommended doses (50 mg to 100 mg every four to six hours, not to exceed 400 mg daily). Most of those affected were healthy and between the ages of 20 and 39 years. Doctors are warned that people taking antidepressants and Ultram were at the highest risk for seizures.