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New Study Shows Tapentadol Extended Release (ER) May Significantly Reduce Average Pain Intensity for Diabetic Patients Suffering From Painful Peripheral Neuropathy
Date:1/28/2011

sting increased intracranial pressure.

NUCYNTA® 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® can be abused in a manner similar to other mu-opioid agonists, legal or illicit. This should be considered when prescribing or dispensing NUCYNTA® 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 addiction.  NUCYNTA® 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.

Experience with NUCYNTA® overdose is very limited. Management of overdose should be focused on treating symptoms of mu-opioid agonism. Primary attention should be given to reestablishment of a patent airway and institution of assisted or controlled ventilation when overdose of NUCYNTA® is suspected. Supportive measures (including oxygen and vasopressors) should be employed in the management of circulatory shock and pulmonary edema accompanying overdose as indicated. Cardiac arrest or arrhythmias may require cardiac massage or defibrillation.

Patients should be cautioned that NUCYNTA® 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® has not been systematically evaluated in patients with a seizure disorder, and such patients were excluded from clinical studies.  NUCYNTA® should be prescribed with care in p
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SOURCE Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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