Active ingredient(s) and Contents

• Effective components

  • Levetiracetam 250 mg, 500 mg, 750 mg, 1000 mg

• Other

  • - Episk Tab. 250 mg: Sodium Starch Glycolate, Colloidal Silicon Dioxide, Povidone, Magnesium Stearate, Opadry (85F20694)
    
    - Episk Tab. 500 mg: Talc, Sodium Starch Glycolate, Polyethylene Glycol 6000, Titanium Oxide, Hydrated Ferric Oxide, Povidone, Magnesium Stearate, Hypromellose 2910, Colloidal Silicon Dioxide
    
    - Episk Tab. 750 mg: Sodium Starch Glycolate, Polyethylene Glycol 6000, Titanium Oxide, Hydrated Ferric Oxide, Povidone, Ferric Oxide, red, Talc, Hypromellose 2910, Magnesium Stearate, Colloidal Silicon Dioxide
    
    - Episk Tab. 1000 mg: Talc, Sodium Starch Glycolate, Polyethylene Glycol 6000, Titanium Oxide, Povidone, Magnesium Stearate, Hypromellose 2910, Colloidal Silicon Dioxide

Dosage and administration

• Film-coated tablets and liquids are administered orally and can be administered regardless of meals, and taken with a sufficient amount of water. The daily dose is divided into equal doses twice daily and administered.
  
  1. Monotherapy
  Adults and adolescents 16 years of age and older:
  The recommended starting dose is 250 mg twice daily which should be increased to an initial therapeutic dose of 500 mg twice daily after two weeks. The dose can be further increased by 500 mg/day (250 mg twice daily) every two weeks depending upon the clinical response, and the maximum dose is 3000 mg/day (1500 mg twice daily).
  
  2. Adjunctive therapy
  1) Partial seizures
  (1) Adults (18 years of age and older) and adolescents >50 kg (12 to 17 years of age):
  The initial therapeutic dose is 500 mg twice daily. Depending on the clinical response and tolerability, dose changes can be made in 1000 mg (500 mg twice daily) increases or decreases every two to four weeks, up to the maximum dose of 3000 mg/day.
  (2) pediatric use 4 to 11 years of age and adolescents 12 to 17 years of age weighing less than 50 kg:
  The initial therapeutic dose is 10 mg/kg twice daily.
  Depending on the clinical response and the patient’s level of tolerability, the dose can be increased to 60 mg/kg daily(30 mg/kg twice daily). Dose changes may not be increased in excess of 20mg/kg(10mg/kg twice daily) during a period of two weeks. Administer the lowest effective dose. The dose for pediatric use weighing more than 50 kg is the same as for adults.
  
  2) Myoclonic seizures in pediatric patients (12 years or older):
  The initial therapeutic dose is 500 mg twice daily. The dose can be further increased by 1,000 mg daily every two weeks, reaching the daily recommended dose of 3,000 mg. Efficacy has not been studied at doses less than 3,000 mg daily.
  
  3) Primary general ankylosing-epileptic seizures (12 years and older):
  (1) Adults (18 years or older) and adolescents (12 to 17 years of age) weighing 50kg or more:
  The initial therapeutic dose is 1,000 mg daily (500 mg twice daily). The dose can be further increased by 1,000 mg daily (500 mg twice daily) every two weeks, reaching the daily recommended dose of 3,000 mg (1,500 mg twice daily). Efficacy has not been studied at doses less than 3,000 mg daily.
  (2) Adolescents 12 to 17 years of age weighing less than 50 kg:
  The initial therapeutic dose is 20 mg/kg daily (10 mg/kg twice daily). The dose can be further increased by 20 mg/kg daily (10 mg/kg twice daily) every two weeks, which may be increased to a daily maximum dose of 60 mg/kg (30 mg/kg twice daily). Efficacy has not been studied at doses less than 60 mg/kg daily.
  
  * See product information about dose adjustments in patients with renal impairment and with hepatic impairment.

Storage and handling

• Airtight container, keep at room temperature (1~30°C)