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• Adults 16 Years and Older: 500 mg twice daily, increase by 500 mg twice daily every 2 weeks to recommended dose of 1500 mg twice daily (2.4) Adult Patients with Impaired Renal Function • Dose adjustment is recommended, based on the patient’s estimated creatinine clearance (2.5, 8.6) –DOSAGE FORMS AND STRENGTHS- • 250 mg, 500 mg, 750 mg, and 1000 mg film-coated, scored tablets (3) • 100 mg/mL solution (3) –CONTRAINDICATIONS—- Known hypersensitivity to levetiracetam; angioedema and anaphylaxis have occurred (4) -WARNINGS AND PRECAUTIONS- • Behavioral abnormalities including psychotic symptoms, suicidal ideation, irritability, and aggressive behavior have been observed; monitor patients for psychiatric signs and symptoms (5.1) • Suicidal Behavior and Ideation: Monitor patients for new or worsening depression, suicidal thoughts/behavior, and/or unusual changes in mood or behavior (5.2) • Monitor for somnolence and fatigue and advise patients not to drive or operate machinery until they have gained sufficient experience on KEPPRA (5.3) • Withdrawal Seizures: KEPPRA must be gradually withdrawn (5.7) -ADVERSE REACTIONS- Most common adverse reactions incidence 25% more than placebo) include: • Adult patients: somnolence, asthenia, infection and dizziness (6.1) • Pediatric patients: fatigue, aggression, nasal congestion, decreased appetite, and irritability (6.1) To report SUSPECTED ADVERSE REACTIONS, contact UCB, Inc. at 866-822-0068 or FDA at 1-800-FDA-1088 or www.fda.gow medwatch. -USE IN SPECIFIC POPULATI NS- Pregnancy: Plasma levels of levetiracetam may be decreased and therefore need to be monitored closely during pregnancy. Based on animal data, may cause fetal harm (5.10.8.1)
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