FDA Approves Tapentadol Immediate-Release Tablets for Relief of Moderate to Severe ...(pain inhibit the transmission of pain at...),Health

Date:11/21/2008

pain, inhibit the transmission of pain at the spinal cord and affect activity at parts of the brain that control how pain is perceived. Norepinephrine reuptake inhibitors are a type of central nervous system medication that increases the level of norepinephrine in the brain by inhibiting its re-absorption into nerve cells; these compounds have analgesic properties.

IMPORTANT SAFETY INFORMATION

Tapentadol is contraindicated in any situation where mu-opioid agonists are contraindicated (i.e., significant respiratory depression, acute or severe bronchial asthma or hypercapnia); in patients with paralytic ileus; or in patients currently using or within 14 days of using monoamine oxidase inhibitors (MAOI).

Due to its mu-opioid receptor agonism, respiratory depression is a possible adverse event of tapentadol. Tapentadol 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. Patients receiving other mu-opioid agonist analgesics, general anesthetics, phenothiazines, other tranquilizers, sedatives, hypnotics, or other CNS depressants (including alcohol, opioids or illicit drugs) concomitantly with tapentadol may exhibit an additive CNS depression. Interactive effects resulting in respiratory depression, hypotension, profound sedation, or coma may result if these drugs are taken in combination with tapentadol. When such combined therapy is contemplated, a dose reduction of one or both agents should be considered.

Like other drugs with mu-opioid agonist activity, tapentadol should not be used in patients susceptible to increased intracranial pressure, impaired consciousness, or coma. It should be used with cau
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SOURCE Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Copyright©2008 PR Newswire. All rights reserved

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