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New Phase 3 Study of Tapentadol Immediate Release Tablets Published in Current Medical Research and Opinion Journal
Date:5/26/2009

ated in patients with a seizure disorder, and such patients were excluded from clinical studies. NUCYNTA(TM) 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 NUCYNTA(TM), 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). Serotonin syndrome may include mental-status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).

Pregnancy-Category C. There are no adequate and well-controlled studies of NUCYNTA(TM) in pregnant women. NUCYNTA(TM) should be used during pregnancy ONLY if the potential benefit justifies the potential risk to the fetus.

Withdrawal symptoms may occur if NUCYNTA(TM) is discontinued abruptly. These symptoms may include: anxiety, sweating, insomnia, rigors, pain, nausea, tremors, diarrhea, upper respiratory symptoms, piloerection, and rarely, hallucinations. Withdrawal symptoms may be reduced by tapering NUCYNTA(TM).

NUCYNTA(TM) is not recommended in patients with severe renal or hepatic impairment. NUCYNTA(TM) should be used with caution in patients with moderate hepatic impairment. Like other drugs with mu-opioid agonist activity, NUCYNTA(TM) may cause spasm of the sphincter of Oddi and should be used with caution in patients with biliary tract disease, including acute pancreatitis.

The most common adverse events are nausea, dizziness, vomiting, somnolence and headache.

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SOURCE Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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