Levetiracetamdosage

Initiate treatment with a dose of 1000 mg once daily; increase by 1000 mg every 2 weeks to a maximum recommended dose of 3000 mg once daily See full prescribing information for use in patients with impaired renal function

2.1 Recommended

Dosing For adults and adolescent patients, the recommended dosing for monotherapy and adjunctive therapy is the same; as outlined below. Adults and Adolescents 12 Years of Age and Older Weighing 50 kg or More Initiate treatment with a dose of 1000 mg once daily. The once daily dosage may be adjusted in increments of 1000 mg every 2 weeks to a maximum recommended daily dose of 3000 mg/day once daily. Administration KEPPRA XR is administered once daily. KEPPRA XR tablets should be swallowed whole. The tablets should not be chewed, broken, or crushed.

2.2 Dosage Adjustments in

Adult Patients with Renal Impairment KEPPRA XR dosing must be individualized according to the patient's renal function status. Recommended dosage adjustments for adults are shown in Table 1. In order to calculate the dose recommended for patients with renal impairment, creatinine clearance adjusted for body surface area must be calculated. To do this, an estimate of the patient's creatinine clearance (CLcr) in mL/min must first be calculated using the following formula: CLcr= [140-age (years)] × weight (kg) -------------------------------------- (× 0.85 for female patients) 72 × serum creatinine (mg/dL) Then CLcr is adjusted for body surface area (BSA) as follows: CLcr (mL/min/1.73m 2 )= CLcr (mL/min) ------------------------- ×

1.73 BSA subject (m 2 )

Table 1: Dosage Adjustment Regimen for Adult Patients with Renal Impairment Group Creatinine Clearance (mL/min/1.73m 2 ) Dosage (mg) Frequency Normal > 80 1000 to 3000 Every 24 hours Mild 50 – 80 1000 to 2000 Every 24 hours Moderate 30 – 50 500 to 1500 Every 24 hours Severe < 30 500 to 1000 Every 24 hours

2.3 Discontinuation of KEPPRA XR

Avoid abrupt withdrawal from KEPPRA XR in order to reduce the risk of increased seizure frequency and status epilepticus.