文档介绍：KEPPRA XR NDA 022285/S-020
FDA Approved Labeling Text Aug 2014
HIGHLIGHTS OF PRESCRIBING INFORMATION • None (4)
These highlights do not include all the information needed to use
KEPPRA XR® safely and effectively. See full prescribing information for -----------------------WARNINGS AND PRECAUTIONS-----------------------­
KEPPRA XR. • Psychiatric Reactions: Monitor patients for behavioral abnormalities
including psychotic symptoms, suicidal ideation, irritability, and
KEPPRA XR (levetiracetam) extended-release tablets, for oral use aggressive behavior ()
Initial . Approval: 1999 • Suicidal Behavior and Ideation: Monitor patients for new or worsening
depression, suicidal thoughts/behavior, and/or unusual changes in mood
----------------------------RECENT MAJOR CHANGES-------------------------­ or behavior ()
Indications and Usage (1) [xx/2014] • Somnolence and Fatigue: Monitor patients for these symptoms and
Warnings and Precautions (, , ) [xx/2014] advise patients not to drive or operate machinery until they have gained
sufficient experience on KEPPRA XR ()
----------------------------INDIC