FDA Approves Tapentadol Immediate-Release Tablets for Relief of Moderate to Severe ...(tion in patients with head injury intrac...),Health

Date:11/21/2008

tion in patients with head injury, intracranial lesions, or other sources of preexisting increased intracranial pressure. Tapentadol should be used with caution in patients with pancreatic or biliary tract disease, and moderate hepatic impairment. Because elderly patients are more likely to have decreased renal and hepatic function, consideration should be given to starting elderly patients with the lower range of recommended doses.

Tapentadol can be abused in a manner similar to other mu-opioid agonists, legal or illicit. This should be considered when prescribing or dispensing tapentadol in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion. Abuse of tapentadol poses a risk of overdose and death. This risk is increased with concurrent abuse of tapentadol with alcohol and other substances. Monitor patients closely for signs of abuse and addiction.

Tapentadol may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Tapentadol should be prescribed with care in patients with a history of a seizure disorder or any condition that would put the patient at risk of seizures.

The development of a potentially life-threatening serotonin syndrome may occur with use of SNRI products, including tapentadol, particularly with concomitant use of serotonergic drugs such as SSRIs, SNRIs, TCAs, MAOIs and triptans, and with drugs which impair metabolism of serotonin (including MAOIs).

The most common adverse events (greater than or equal to 10% in any tapentadol dose group) in clinical trials were nausea, dizziness, vomiting, somnolence and headache.

For information about the package insert for tapentadol, consult the FDA Web site.

Johnson & Johnson Pharmaceutical Research & Development
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SOURCE Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Copyright©2008 PR Newswire. All rights reserved

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