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Supplemental New Drug Application Submitted to FDA for NUCYNTA® ER (Tapentadol) Extended-Release Tablets for Diabetic Peripheral Neuropathic Pain
Date:10/31/2011

patic function. Tapentadol should be used with caution in patients with moderate hepatic impairment. NUCYNTA® ER has not been studied in patients with severe hepatic impairment, and use in this population is not recommended.
  • Like other drugs with mu-opioid agonist activity, NUCYNTA® ER may cause spasm of the sphincter of Oddi and should be used with caution in patients with biliary tract disease, including acute pancreatitis.
  • NUCYNTA® ER should be used with caution in the following conditions: adrenocortical insufficiency (eg, Addison's disease); delirium tremens; myxedema or hypothyroidism; prostatic hypertrophy or urethral stricture; and toxic psychosis.
  • Pregnancy Category C. There are no adequate and well-controlled studies of NUCYNTA® ER in pregnant women. NUCYNTA® ER should be used during pregnancy ONLY if the potential benefit justifies the potential risk to the fetus.
  • ADVERSE REACTIONS

    • The most common (>/=10%) adverse reactions were nausea, constipation, headache, dizziness, and somnolence.

    Please see full Product Information for NUCYNTA® at http://www.nucynta.com/

    IMPORTANT SAFETY INFORMATION for NUCYNTA® (tapentadol) immediate release

    CONTRAINDICATIONS

    • Like other drugs with mu-opioid agonist activity, NUCYNTA® is contraindicated in patients with significant respiratory depression, acute or severe bronchial asthma or hypercapnia in unmonitored settings or in the absence of resuscitative equipment. NUCYNTA® is contraindicated in patients who have or are suspected to have paralytic ileus. NUCYNTA® is also contraindicated in patients currently using or within 14 days of using monoamine oxidase inhibitors (MAOI
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    SOURCE Janssen Pharmaceuticals Research & Development
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