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Ultracet (Tramadol/Acetaminophen) Appears Effective, Well Tolerated for Post-Surgical Pain

RARITAN, NJ -- April 5, 2004 -- A new study published in the latest edition of a leading medical journal has shown that treatment with Ultracet® (37.5 mg tramadol hydrochloride/325 mg acetaminophen tablets) demonstrates similar efficacy and better tolerability than TYLENOL® with Codeine No. 3 when each is compared to placebo.

Study results published in the April issue of American Journal of Surgery found that pain associated with orthopedic or abdominal surgery was successfully reduced following treatment with Ultracet, a leading combination pain reliever marketed by Ortho-McNeil Pharmaceutical, Inc. In an overall review, 69% of patients taking Ultracet rated it as very good or good compared with 62% of patients who were prescribed Tylenol with Codeine No. 3.

"Treating pain following surgery with narcotics including Tylenol with Codeine No. 3 has long been the preferred method of health care professionals, but this often leaves patients in a state of immobility due to narcotic side effects, like fatigue, nausea or abdominal discomfort," said Adam B. Smith, D.O., Department of Surgery, University of North Texas Health Science Center, Fort Worth, Texas. "This study found that Ultracet delivers efficacy but with fewer side effects."

The rate of constipation for patients treated with Ultracet was less than half the rate experienced by patients treated with Tylenol with Codeine No. 3 (4.1% vs. 10.1%). Also, patients treated with Ultracet experienced less vomiting (9.2% vs. 14.7%) and discontinuation due to adverse events (8.2% vs. 10.1%) than in patients treated with Tylenol with Codeine No. 3.

This multicenter, randomized, double-blind, placebo-controlled trial evaluated Ultracet in 153 orthopedic patients (arthroscopic procedure of the knee or shoulder) and 152 abdominal surgery patients (inguinal or ventral hernia repair) for post-surgical pain. Patients with moderate pain or greater were treated with Ultracet, Tylenol with Codeine No. 3 or placebo. Outcome measures were pain relief and pain intensity. The study was supported by Ortho-McNeil Pharmaceutical, Inc.

Ultracet combines tramadol, a leading prescription pain reliever, with acetaminophen, the most commonly recommended nonprescription pain treatment. Single-dose dental pain studies demonstrated that the Ultracet combination of tramadol and acetaminophen provides faster onset, longer duration and better pain relief over either medication alone.

Ultracet is indicated for the short-term (five days or less) management of acute pain.

Ultracet is contraindicated in any situation where opioids are contraindicated.

Seizures have been reported in patients receiving tramadol. The risk of seizures is increased with doses of tramadol above the recommended range. Tramadol increases the seizure risk in patients taking certain medications (e.g., tricyclic antidepressants, SSRIs, opioids). Tramadol may enhance the seizure risk in patients taking MAO inhibitors, neuroleptics, or other drugs that reduce the seizure threshold or 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). See WARNINGS in full Prescribing Information.

Patients with a history of anaphylactoid reactions to codeine and other opioids may be at increased risk and therefore should not receive Ultracet.

Ultracet should not be used concomitantly with alcohol consumption. The use of Ultracet in patients with liver disease is not recommended. Withdrawal symptoms may occur if Ultracet is discontinued abruptly.

Ultracet should not be used concomitantly with other acetaminophen- containing products.

Tramadol may induce psychic and physical dependence of the morphine type (mu - opioid). Cases of abuse and dependence on tramadol have been reported. Tramadol should not be used in opioid-dependent patients. Since tramadol can reinitiate physical dependence, Ultracet is not recommended for patients with a tendency to drug abuse, a history of drug dependence, or chronically using opioids.

The most frequently reported side effects experienced with Ultracet were constipation, somnolence, and sweating.

For more information on warnings, precautions, and additional adverse reactions that may occur, regardless of drug relationship, please see the full U.S. Prescribing Information available upon request or at http://www.ultracet.com or http://www.ortho-mcneil.com.


SOURCE: Ortho-McNeil Pharmaceutical, Inc.

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