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• Levetiracetam
  

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  Levetiracetam

  

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  Levetiracetam tablets are indicated as adjunctive treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy.

  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), 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 BID). 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 Ages 4 to <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg BID). 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 BID). 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 52 mg/kg. 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. Table 10 below provides a guideline for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered.

  Levetiracetam tablets are given orally with or without food.

  Table 10: Levetiracetam Tablets Weight-Based Dosing Guide for Children Patient Weight Daily Dose

  20 mg/kg/day

  (BID dosing)

  40 mg/kg/day

  (BID dosing)

  60 mg/kg/day

  (BID dosing) 20.1-40 kg

  500 mg/day

  (1 x 250 mg

  tablet BID)

  1000 mg/day

  (1 x 500 mg

  tablet BID)

  1500 mg/day

  (1 x 750 mg

  tablet BID) >40 kg

  1000 mg/day

  (1 x 500 mg

  tablet BID)

  2000 mg/day

  (2 x 500 mg

  tablets BID)

  3000 mg/day

  (2 x 750 mg

  tablets BID)

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients based on a daily dose of 20 mg/kg/day, 40 mg/kg/day or 60 mg/kg/day:

                                                   Daily dose (mg/kg/day) x patient weight (kg)

  Total daily dose (mL/day) = -------------------------------------------------------------------

                                                                         100 mg/mL

  A household teaspoon or tablespoon is not an adequate measuring device. It is recommended that a calibrated measuring device be obtained and used. Healthcare providers should recommend a device that can measure and deliver the prescribed dose accurately, and provide instructions for measuring the dosage.

  Adult Patients with Impaired Renal Function

  Levetiracetam 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 11. To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in mL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL) determination using the following formula:

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

  CLcr =--------------------------------------------- (x 0.85 for female patients)

                      72 x serum creatinine (mg/dL)

  Table 11: Dosing Adjustment Regimen for Adult Patients with Impaired Renal Function Group

  Creatinine Clearance

  (mL/min)

  Dosage

  (mg) Frequency Normal > 80 500 to 1,500 Every 12 h Mild 50 – 80 500 to 1,000 Every 12 h Moderate 30 – 50 250 to 750 Every 12 h Severe < 30 250 to 500 Every 12 h ESRD patients using dialysis --- 500 to 1,000 Every 24 h

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