2.1 Important Administration Instructions
Levetiracetam tablets are given orally with or without food. The levetiracetam dosing regimen depends on the indication, age group, dosage form (tablets or oral solution), and renal function.
Prescribe the oral solution for pediatric patients with body weight ≤ 20 kg. Prescribe the oral solution or tablets for pediatric patients with body weight above 20 kg.
When using the oral solution in pediatric patients, dosing is weight-based (mg per kg) using calibrated measuring device (not a household teaspoon or tablespoon).
Levetiracetam tablets should be swallowed whole. Levetiracetam tablets should not be chewed or crushed.
2.2 Dosing for Partial Onset Seizures
Adults 16 Years and Older
Initiate treatment with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. There is no evidence that doses greater than 3000 mg/day confer additional benefit.
Pediatric Patients
1 Month to < 6 Months:
Initiate treatment with a daily dose of 14mg/kg in 2 divided doses (7 mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 14 mg/kg to recommended daily dose of 42 mg/kg (21 mg/kg twice daily). In the clinical trial, the mean daily dose was 35 mg/kg in this age group. The effectiveness of lower doses has not been studied.
6 Months to < 4 Years:
Initiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). Increase the daily dose in 2 weeks by an increment of 20 mg/kg to the recommended daily dose of 50 mg/kg (25 mg/kg twice daily). If a patient cannot tolerate a daily dose of 50 mg/kg, the daily dose may be reduced. In clinical trial, the mean daily dose was 47 mg/kg in this age group.
4 Years to < 16 Years:
Initiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 44 mg/kg. The maximum daily dose was 3000 mg/day.
For levetiracetam tablet dosing in pediatric patients weighing 20 to 40 kg, initiate treatment with a daily dose of 500 mg given as twice daily dosing (250 mg twice daily). Increase the daily dose every 2 weeks by increments of 500 mg to a maximum recommended daily dose of 1500 mg (750 mg twice daily).
For levetiracetam tablet dosing in pediatric patients weighing more than 40 kg, initiate treatment with a daily dose of 1000 mg/day given as twice daily dosing (500 mg twice daily). Increase the daily dose every 2 weeks by increments of 1000 mg/day to a maximum recommended daily dose of 3000 mg (1500 mg twice daily).
Levetiracetam Oral Solution Weight-Based Dosing Calculation For Pediatric Patients
The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients:
2.3 Dosing for Myoclonic Seizures in Patients 12 Years of Age and Older With Juvenile Myoclonic Epilepsy
Initiate treatment with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Increase the dosage by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been studied.
2.4 Dosing for Primary Generalized Tonic-Clonic Seizures
Adults 16 Years and Older
Initiate treatment with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Increase the dosage by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.
Pediatric Patients Ages 6 to <16 Years
Initiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied. Patients with body weight ≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution [see DOSAGE AND ADMINISTRATION (2.1)]. Only whole tablets should be administered.
2.5 Dosage Adjustments in Adult Patients with Renal Impairment
Levetiracetam tablets dosing must be individualized according to the patient's renal function status. Recommended dosage adjustments 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:
Table 1: Dosing Adjustment Regimen for Adult Patients with Renal Impairment
Table 1: Dosing Adjustment Regimen for Adult Patients with Renal Impairment
*
Following dialysis, a 250 to 500 mg supplemental dose is recommended.
Group
Creatinine Clearance
(mL/min/1.73 m2)
Dosage (mg)
Frequency
Normal
>80
500 to 1,500
Every 12 hours
Mild
50 to 80
500 to 1,000
Every 12 hours
Moderate
30 to 50
250 to 750
Every 12 hours
Severe
<30
250 to 500
Every 12 hours
ESRD patients using dialysis
-----
500 to 1000*
Every 24 hours*
