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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

or hypercapnia in unmonitored settings or the absence of resuscitative equipment. NUCYNTA(TM) is contraindicated in patients with suspected or confirmed cases of paralytic ileus. NUCYNTA(TM) is also contraindicated in patients currently using or within 14 days of using monoamine oxidase inhibitors (MAOI) due to potential additive effects on norepinephrine levels, which may result in adverse cardiovascular events.

Respiratory depression is the primary risk of mu-opioid agonists. Respiratory depression occurs more frequently in elderly or debilitated patients and in those suffering from conditions accompanied by hypoxia, hypercapnia, or upper airway obstruction, in whom even moderate therapeutic doses may significantly decrease pulmonary ventilation. NUCYNTA(TM) should be administered with caution to the elderly, debilitated patients, and patients with conditions accompanied by hypoxia, hypercapnia or decreased respiratory reserve such as: asthma, chronic obstructive pulmonary disease or cor pulmonale, severe obesity, sleep apnea syndrome, myxedema, kyphoscoliosis, CNS depression, or coma. In such patients, even usual therapeutic doses of NUCYNTA(TM) may increase airway resistance and decrease respiratory drive to the point of apnea. Alternative non-mu-opioid agonist analgesics should be considered and NUCYNTA(TM) should be employed only under careful medical supervision at the lowest effective dose in such patients. If respiratory depression occurs, it should be treated as any mu-opioid agonist-induced respiratory depression.

Patients receiving other mu-opioid agonist analgesics, general anesthetics, phenothiazines, other tranquilizers, sedatives, hypnotics, or other CNS depressants (including alcohol, other opioids or illicit drugs) concomitantly with NUCYNTA(TM) may exhibit additive CNS depression. Interactive effects resulting in respiratory depression, hypotension, profound sedation, coma or death may result if these drugs
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SOURCE Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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