Levetiracetam

LEVETIRACETAM- levetiracetam tablet, film coated
Redpharm Drug, Inc.

1 INDICATIONS & USAGE

1.1 Partial Onset Seizures

Levetiracetam tablet 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 tablet 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 tablet 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 & ADMINISTRATION

2.1 Important Administration Instructions

Levetiracetam tablet is given orally with or without food. The levetiracetam tablets dosing regimen depends on the indication, age group, dosage form (tablets or oral solution), and renal function.
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 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.
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 1,500 mg
(750 mg twice daily).
For levetiracetam tablet dosing in pediatric patients weighing more than 40 kg, initiate treatment with a daily dose of 1,000 mg/day given as twice daily dosing (500 mg twice daily). Increase the daily dose every 2 weeks by increments of 1,000 mg/day to a maximum recommended daily dose of 3,000 mg (1,500 mg twice daily).

2.3 Dosing for Myoclonic 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 for Primary 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 tablets [ 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 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/1.73m 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 hours 1

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

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