To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: FDA Approves Ultracet (Tramadol/Acetominophen) For Acute Pain URL: http://www.pslgroup.com/dg/2040FE.htm Doctor's Guide August 20, 2001
RARITAN, NJ -- August 20, 2001 -- The U.S. Food and Drug Administration has approved Ultracet™ (37.5 mg tramadol hydrochloride/325 mg acetaminophen tablets), a new centrally acting prescription pain medication. Ultracet provides long-lasting pain relief and flexible dosing. Ortho-McNeil Pharmaceutical, Inc. will market the product in the United States.
Ultracet combines Ultram® (tramadol hydrochloride), a leading prescription pain reliever, with acetaminophen, the most commonly recommended nonprescription pain treatment. Clinical trials demonstrated that the combination offers better pain relief over either medication alone. In the trials, Ultracet consistently began working faster than tramadol alone, and pain relief with Ultracet lasted significantly longer than with acetaminophen alone.
Ultracet is indicated for the short-term (five days or less) management of acute pain.
"Pain is one of the most prevalent medical symptoms in the United States," said Warren A. Katz, MD, chief of Rheumatology at Presbyterian Medical Center/University of Pennsylvania Healthcare System in Philadelphia. "Millions of people suffer from acute pain without relief, in part because their medications don't work or have side-effects that interfere with treatment. With Ultracet, we have a product that offers effective relief and a positive side-effect profile."
Ultracet™ is a centrally acting analgesic that controls pain via different mechanisms of action than non-steroidal anti-inflammatory drugs (NSAIDs), the most commonly used pain medications. Ultracet is not an NSAID, and is not associated with potentially life-threatening gastrointestinal ulcers or bleeding that can occur with NSAIDs and the newer COX-2 NSAIDs.
In addition, Ultracet does not compromise the efficacy of certain antihypertensive agents, like NSAIDs and COX-2 NSAIDs. Ultracet can also be prescribed in sulfa-sensitive patients. The most frequently reported side effects with Ultracet were constipation, somnolence (sleepiness) and increased sweating.
Ultracet should not be used concomitantly with alcohol. The use of Ultracet in patients with liver disease is not recommended. In addition, acetaminophen may cause liver damage.
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 or alcohol abuse, a history of drug or alcohol dependence or a history of chronic opioid use.
Patients with a history of severe, life-threatening allergic (anaphylactoid) reactions to codeine and other opioids may be at increased risk and therefore should not receive Ultracet.
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, selective serotonin reuptake inhibitors, opioids) and 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, and CNS infections). See WARNINGS in the full Prescribing Information.
SOURCE: Ortho-McNeil Pharmaceutical, Inc.
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