Levetiracetam extended-release tablet is administered once daily.
Treatment should be initiated with a dose of 1,000 mg once daily. The once daily dosage may be adjusted in increments of 1,000 mg every 2 weeks to a maximum recommended once daily dose of 3,000 mg.
2.1 Adult Patients with Impaired Renal Function
Levetiracetam extended-release tablets dosing must be individualized according to the patient's renal function status. Recommended doses and adjustment for dose 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:
[140-age (years)] x weight (kg)
CLcr = ---------------------------------------------- (x 0.85 for female patients)
72 x serum creatinine (mg/dL)
Then CLcr is adjusted for body surface area (BSA) as follows:
CLcr (mL/min)
CLcr (mL/min/1.73m2) = ----------------------------- x 1.73
BSA subject (m2)
Table 1: Dosing Adjustment Regimen For Adult Patients With Impaired Renal Function
Group
Creatinine
Clearance
(mL/min/1.73m2
Dosage
(mg)
Frequency
Normal
> 80
1,000 to 3,000
Every 24 hours
Mild
50 to 80
1,000 to 2,000
Every 24 hours
Moderate
30 to 50
500 to 1,500
Every 24 hours
Severe
< 30
500 to 1,000
Every 24 hours