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Keppra XR(TM) Extended-Release Tablets Filed with the FDA
Date:1/16/2008

older with juvenile myoclonic epilepsy, and primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy. Keppra(R) injection is indicated as adjunctive therapy in the treatment of myoclonic seizures in juvenile myoclonic epilepsy and partial onset seizures in adults with epilepsy. Keppra(R) injection is an alternative for patients when oral administration is temporarily not feasible.

Keppra(R) tablets and oral solution are associated with the occurrence of central nervous system adverse events including somnolence and fatigue, behavioral abnormalities, as well as hematological abnormalities. In adults experiencing partial onset seizures, Keppra(R) is also associated with coordination difficulties. In adults experiencing partial onset seizures, the most common adverse events associated with Keppra(R) in combination with other AEDs were somnolence, asthenia, infection and dizziness. In pediatric patients 4-16 years of age experiencing partial onset seizures, the most common adverse events associated with Keppra(R) in combination with other AEDs were somnolence, accidental injury, hostility, nervousness and asthenia. In patients 12 years of age and older with juvenile myoclonic epilepsy, the most common adverse events associated with Keppra(R) in combination with other AEDs were somnolence, neck pain, and pharyngitis. In patients 6 years of age and older with idiopathic generalized epilepsy, the most common adverse event associated with Keppra(R) in combination with other AEDs was nasopharyngitis.

The adverse events that result from Keppra(R) injection use for myoclonic seizures in juvenile myoclonic epilepsy and partial onset seizures in adults include all of those associated with Keppra(R) tablets and oral solution.

U.S. prescribing information is available at http://www.keppra.com or by calling 1-866-822-0068.

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SOURCE UCB
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