Levion 500 mg (Levetiracetam)

Adult dose

Film-coated tablets and the oral solution are administered orally, regardless of meals, and should be taken with plenty of water. The daily dose should be divided into two equal doses and administered twice daily. Levetiracetam treatment may be initiated by intravenous or oral administration. When switching from oral to intravenous administration or vice versa, the route may be changed directly without dose titration; the total daily dose and frequency of administration should remain the same. 1. Monotherapy and adjunctive therapy for partial-onset seizures (4 years and older) Adults (18 years and older) and adolescents weighing 50kg or more (12~17 years) Start this drug at 500mg twice daily. Depending on clinical response and tolerability, the dose may be increased or decreased by 1000mg per day [500mg per dose, twice daily] every 2 to 4 weeks; the maximum recommended dose is 3000mg per day. 2. Adjunctive therapy for myoclonic seizures in pediatric patients (12 years and older) Start this drug at 500mg twice daily. The dose is increased by 1,000mg per day every 2 weeks up to the recommended daily dose of 3,000mg. Efficacy at doses below 3,000mg per day has not been studied. 3. Adjunctive therapy for primary generalized tonic-clonic seizures (12 years and older) Adults (18 years and older) and adolescents weighing 50kg or more (12-17 years) Start this drug at 1,000mg per day [500mg per dose, twice daily]. The dose is increased by 1,000mg per day [500mg per dose, twice daily] every 2 weeks up to the recommended daily dose of 3,000mg [1,500mg per dose, twice daily]. Efficacy at doses below 3,000mg per day has not been adequately studied. 4. Patients with renal impairment Since levetiracetam clearance is related to renal function, the dose should be individualized according to the patient's renal function. Refer to the table below for dosage adjustment in adults. Dosage adjustment for adult patients with renal impairment Normal (≧ 80): 500-1,500mg, twice daily (12-hour intervals) Mild (50-79): 500-1,000mg, twice daily (12-hour intervals) Moderate (30-49): 250-750mg, twice daily (12-hour intervals) Severe (< 30): 250-500mg, twice daily (12-hour intervals) End-stage renal disease patients on dialysis(1) (-): 500-1,000mg, once daily(2) (1) An initial loading dose of 750mg is recommended on the first day of treatment. (2) An additional dose of 250-500mg is recommended after dialysis. 5. Patients with hepatic impairment No dosage adjustment is necessary in patients with mild to moderate hepatic impairment. In patients with severe hepatic impairment, creatinine clearance may underestimate renal impairment. Therefore, if creatinine clearance is less than 60mL/min/1.73m2, it is recommended that the daily maintenance dose be reduced by 50%. 7. Elderly patients (65 years and older) Dosage adjustment is recommended in elderly patients with reduced renal function.

Child dose

Children aged 4~11 years and adolescents aged 12~17 years weighing less than 50kg: Start at 10mg/kg per dose twice daily. Depending on clinical response and tolerability, the dose may be increased to 60mg/kg per day [30mg/kg per dose, twice daily]; dose adjustments should not exceed increases or decreases of 20mg/kg per day [10mg/kg per dose, twice daily] every 2 weeks. Use the lowest effective dose. The maximum recommended dose is 3000mg per day. For children weighing 20kg or less, it is recommended to start treatment with the 100mg/ml oral solution. For children weighing 20~40kg, start at 500mg per day [250mg per dose, twice daily]; the dose may be increased by 500mg per day every 2 weeks to a maximum of 1500mg per day [750mg per dose, twice daily]. For children weighing more than 40kg, start at 1000mg per day [500mg per dose, twice daily]; the dose may be increased by 1000mg per day every 2 weeks to a maximum of 3000mg per day [1500mg per dose, twice daily]. The dose for children weighing 50kg or more is the same as the adult dose. Adolescents aged 12-17 years weighing less than 50kg Start this drug at 20mg/kg per day [10mg/kg per dose, twice daily]. The dose is increased by 20mg/kg per day [10mg/kg per dose, twice daily] every 2 weeks up to the recommended daily dose of 60mg/kg [30mg/kg per dose, twice daily]. Efficacy at doses below 60mg/kg per day has not been adequately studied. Use the following formulas for infants, children, and adolescents. ks= 0.45 (infants under 1 year of age) ; ks= 0.55 (female children and adolescents under 13 years of age) ks= 0.7 (male adolescents) Dosage adjustment for pediatric patients and adolescents weighing less than 50kg with renal impairment Normal (≧ 80): 10-30mg/kg(0.10-0.30 ml/kg) twice daily Mild (50-79): 10-20mg/kg(0.10-0.20 ml/kg) twice daily Moderate (30-49): 5-15mg/kg (0.05-0.15ml/kg) twice daily Severe (< 30): 5-10 mg/kg (0.05-0.10ml/kg) twice daily End-stage renal disease patients on dialysis (--): 10-20mg/kg(0.10-0.20 ml/kg) once daily(1)(2) (1) A loading dose of 15 mg/kg(0.15ml/kg) is recommended on the first day of treatment. (2) An additional dose of 5-10 mg/kg(0.05-0.10ml/kg) is recommended after dialysis. 6. Children Oral formulations are not recommended for infants under 1 month of age because of insufficient safety and efficacy data. Tablets are not indicated for children 4 years of age and under; infants 1 month of age and older should receive the oral solution. Injection is not recommended for children under 16 years of age because safety and efficacy have not been established.

This medication may increase the risk of suicidal thoughts or behaviors; patients should immediately inform healthcare professionals of any mood changes or behavioral abnormalities occurring during treatment. During the first 4 weeks of treatment, neurological symptoms such as drowsiness, fatigue, coordination disturbances, and behavioral changes may frequently occur, so caution is needed. Abrupt discontinuation of this medication can increase seizure frequency; therefore, the dosage should be gradually reduced according to the physician's instructions. Patients with known allergies to any component of this medication should not take it, and dosage adjustments may be necessary for patients with impaired kidney function or liver disease. Psychiatric symptoms, aggression, and irritability may occur; consult healthcare professionals if these symptoms appear. If symptoms worsen, seizures may become exacerbated, and immediate consultation with a physician is necessary. Patients with heart disease or prolonged QT interval on ECG should exercise caution when taking this medication. Some patients may experience a decrease in blood cell count or systemic hypersensitivity, so tests are warranted if symptoms such as fever, malaise, or bleeding arise. The effects of this medication on the fetus have not been fully elucidated; therefore, female patients planning to become pregnant or who are pregnant must consult healthcare professionals. During breastfeeding, this medication can be excreted into breast milk and may affect the baby, so careful consideration must be given regarding whether to discontinue breastfeeding or the medication. Cautious dosage adjustments and monitoring are required when administering to children or the elderly. This medication can cause drowsiness or dizziness, so caution should be exercised when driving or operating dangerous machinery. In cases of overdose, methods such as vomiting or gastric lavage can be used to remove the medication; blood dialysis may be performed if necessary. Interactions with other medications are relatively minor, but caution should be taken in combination with methotrexate due to potential elevated blood concentration.

• suicidal thoughts
• suicidal behavior
• depression
• abnormal changes in mood and behavior
• drowsiness
• fatigue
• coordination disorders
• behavioral abnormalities
• weakness
• aggression

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. Additionally, it is important to store it in a temperature range of 1 to 30 degrees Celsius to maintain its effectiveness.

Appearance

Yellow oval film-coated tablets

Package unit

60 tablets/box [10 tablets/PTP x 6]