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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

are taken in combination with NUCYNTA(TM). When such combined therapy is contemplated, a dose reduction of one or both agents should be considered.

Opioid analgesics can raise cerebrospinal fluid pressure as a result of respiratory depression with carbon dioxide retention. Therefore, NUCYNTA(TM) should not be used in patients susceptible to the effects of raised cerebrospinal fluid pressure such as those with head injury and increased intracranial pressure. Opioid analgesics may obscure the clinical course of patients with head injury due to effects on pupillary response and consciousness. NUCYNTA(TM) should be used with caution in patients with head injury, intracranial lesions, or other sources of preexisting increased intracranial pressure.

NUCYNTA(TM) is a mu-opioid agonist and is a Schedule II controlled substance. Such drugs are sought by drug abusers and people with addiction disorders. Diversion of Schedule II products is an act subject to criminal penalty. NUCYNTA(TM) can be abused in a manner similar to other mu-opioid agonists, legal or illicit. This should be considered when prescribing or dispensing NUCYNTA(TM) in situations where the physician or pharmacist is concerned about an increased risk of misuse and abuse. All patients treated with mu-opioid agonists require careful monitoring for signs of abuse and addition. NUCYNTA(TM) may be abused by crushing, chewing, snorting or injecting the product. These practices pose a significant risk to the abuser that could result in overdose and death.

Patients should be cautioned that NUCYNTA(TM) may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. This is to be expected especially at the beginning of treatment, at any change of dosage as well as in combination with alcohol or tranquilizers.

NUCYNTA(TM) has not been systematically evalu
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SOURCE Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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