2.1 Important Administrations Instructions
Levetiracetam oral solution is 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 a calibrated measuring device (not a household teaspoon or tablespoon).
2.2 Partial Onset Seizures
Adults 16 Years And Older
In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing, were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose [see Clinical Studies (14.1)], a consistent increase in response with increased dose has not been shown.
Treatment should be initiated 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. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.
Pediatric Patients
Dosing information in pediatric patients less than 4 years of age as adjunctive therapy in the treatment of partial onset seizures is approved for UCB, Inc.’s levetiracetam oral solution. However, due to UCB, Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
4 Years To <16 Years
Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). The daily dose should be increased 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 efficacy trial, the mean daily dose was 44 mg/kg. The maximum daily dose was 3000 mg/day.
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 Myoclonic Seizures In Patients 12 Years Of Age And Older With Juvenile Myoclonic Epilepsy
Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Dosage should be increased 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 Primary Generalized Tonic-Clonic Seizures
Adults 16 Years And Older
Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Dosage should be increased 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
Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). The daily dose should be increased 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)].
2.5 Adult Patients With Impaired Renal Function
Levetiracetam oral solution 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:
Then CLcr is adjusted for body surface area (BSA) as follows:
Table 1: Dosing Adjustment Regimen For Adult Patients With Impaired Renal Function
Group
Creatinine Clearance (mL/min/1.73m2)
Dosage (mg)
Frequency
1 Following dialysis, a 250 to 500 mg supplemental dose is recommended.
Normal
>80
500 to 1,500
Every 12 hours
Mild
50 - 80
500 to 1,000
Every 12 hours
Moderate
30 - 50
250 to 750
Every 12 hours
Severe
<30
250 to 500
Every 12 hours
ESRD patients using dialysis
----
500 to 1,0001
Every 24 hours1