Epicure 50

• Partial-onset seizures in patients 1 month of age and older

Adults (16 years and older): Initial dose: 50 mg twice daily (100 mg/day). Maintenance: 25-100 mg twice daily (50-200 mg/day).

Children (weight ≥50 kg): Initial: 25-50 mg twice daily (50-100 mg/day). Maintenance: 25-100 mg twice daily (50-200 mg/day).

Children (weight 20 to <50 kg): Initial: 0.5-1 mg/kg twice daily (1-2 mg/kg/day). Maintenance: 0.5-2 mg/kg twice daily (1-4 mg/kg/day).

Children (weight 11 to <20 kg): Initial: 0.5-1.25 mg/kg twice daily (1-2.5 mg/kg/day). Maintenance: 0.5-2.5 mg/kg twice daily (1-5 mg/kg/day).

Children (weight <11 kg): Initial: 0.75-1.5 mg/kg twice daily (1.5-3 mg/kg/day). Maintenance: 0.75-3 mg/kg twice daily (1.5-6 mg/kg/day).

Hepatic impairment (all stages): Reduce starting dose to 25 mg twice daily and do not exceed 75 mg twice daily (150 mg/day).

Renal impairment: Mild-moderate: No dose adjustment. ESRD (dialysis): Not studied.

Elderly: Start at the low end of the dosing range.

IV administration: When oral administration is temporarily not feasible, same dose and frequency IV (up to 4 consecutive days).

Common side effects (≥5% and at least 2% more frequent than placebo): Somnolence/sedation, dizziness, fatigue, nausea/vomiting.

Other common: Headache, constipation, irritability, anxiety, nervousness, aggression, agitation, restlessness, depression, abnormal behavior.

Serious (rare): Stevens-Johnson syndrome, toxic epidermal necrolysis (potentially fatal skin reactions), bronchospasm, angioedema (hypersensitivity reactions), suicidal thoughts or behavior.

Side effects are more common during the first few weeks and usually lessen as the body adjusts to the medication.

• Antiepileptic drugs, including brivaracetam, increase the risk of suicidal thoughts or behavior; monitor patients for changes in mood or behavior.
• May cause somnolence, fatigue, dizziness, and coordination disturbances; advise patients not to drive or operate machinery.
• Psychiatric adverse reactions (non-psychotic: irritability, anxiety, aggression, agitation, depression; psychotic: hallucinations, paranoia) may occur; monitor patients.
• Do not stop abruptly due to risk of increased seizure frequency and status epilepticus; withdraw gradually.
• Caution in hepatic impairment (dose adjustment may be needed).
• Use during pregnancy only if clearly needed (animal studies show potential fetal harm).
• Limited data on breastfeeding; brivaracetam is excreted in breast milk; monitor exclusively breastfed infants for drowsiness, agitation, weight gain, and developmental milestones.