Levetiracetam Levetiracetam

LEVETIRACETAM LEVETIRACETAM- levetiracetam solution
AvPAK

1 INDICATIONS AND USAGE

1.1 Partial Onset Seizures

Levetiracetam oral solution is indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 1 month of age and older with epilepsy.

1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy

Levetiracetam oral solution is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy.

1.3 Primary Generalized Tonic-Clonic Seizures

Levetiracetam oral solution is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions

Levetiracetam oral solution is given orally with or without food. The levetiracetam oral solution 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).

2.2Dosing forPartial Onset Seizures

Adults 16 Years and Older
Initiate treatment with a daily dose of 1,000 mg/day, given as twice-daily dosing (500 mg twice daily). Additional dosing increments may be given (1,000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3,000 mg. There is no evidence that doses greater than 3,000 mg/day confer additional benefit.
Pediatric Patients
1 Month to < 6 Months
Initiate treatment with a daily dose of 14 mg/kg in 2 divided doses (7 mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 14 mg/kg to the 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 the 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 3,000 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:
Daily dose (mg/kg/day) x patient weight (kg)
Total daily dose (mL/day) = ——————————————————– 100 mg/mL

2.3 Dosing forMyoclonic Seizures in Patients 12 Years of Age and Older With Juvenile Myoclonic Epilepsy

Initiate treatment with a dose of 1,000 mg/day, given as twice-daily dosing (500 mg twice daily). Increase the dosage by 1,000 mg/day every 2 weeks to the recommended daily dose of 3,000 mg. The effectiveness of doses lower than 3,000 mg/day has not been studied.

2.4 Dosing forPrimary Generalized Tonic-Clonic Seizures

Adults 16 Years and Older
Initiate treatment with a dose of 1,000 mg/day, given as twice-daily dosing (500 mg twice daily). Increase dosage by 1,000 mg/day every 2 weeks to the recommended daily dose of 3,000 mg. The effectiveness of doses lower than 3,000 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)].

2.5 Dosage Adjustments inAdult Patients with Renal Impairment

Levetiracetam oral solution 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:

[140-age (years)] x weight (kg) (x 0.85

CLcr = ————————————— for female 72 x serum creatinine (mg/dL) patients)

Then CLcr is adjusted for body surface area (BSA) as follows:

CLcr (mL/min)

CLcr (mL/min/1.73m ²) = ——————- x 1.73

BSA subject (m ²)

Table 1: Dosing Adjustment Regimen for Adult Patients with Renal Impairment

Group	Creatinine Clearance (mL/min/1.73m 2)	Dosage (mg)	Frequency
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 1,000 1	Every 24 hours1

¹ Following dialysis, a 250 to 500 mg supplemental dose is recommended.