Lotus Pharmaceutical Co., Ltd.

Lotus Pharmaceutical Co., Ltd. Drugs

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  2.1 Important Administration Instructions

  Levetiracetam 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).

  Levetiracetam tablets should be swallowed whole. Levetiracetam tablets should not be chewed or crushed.

  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 tablets and 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.

  For Levetiracetam tablet dosing in pediatric patients weighing 20 to 40 kg, treatment should be initiated with a daily dose of 500 mg given as twice daily dosing (250 mg twice daily). The daily dose should be increased 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, treatment should be initiated with a daily dose of 1000 mg/day given as twice daily dosing (500 mg twice daily). The daily dose should be increased every 2 weeks by increments of 1000 mg/day to a maximum recommended daily dose of 3000 mg (1500 mg twice daily).

  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)]. Only whole tablets should be administered.

  2.5 Adult Patients With Impaired Renal Function

  Levetiracetam 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:           ［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/1.732=––––––––––––––– x 1.73                                 BSA subject(m2)

  Table 1: Dosing Adjustment Regimen For Adult Patients With Impaired Renal Function Group Creatinine Clearance(mL/min/1.73m2) 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 ----- 500 to 1,000* Every 24 hours*

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

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