Keppra 500 mg (Levetiracetam)

Adult dose

Film-coated tablets and oral solution are administered orally and may be taken regardless of meals with a sufficient amount of water. The daily dose should be divided into 2 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, treatment may be switched directly without dose titration, and the total daily dose and frequency of administration should remain the same. Monotherapy Adults The initial dose is 250mg twice daily. After 2 weeks, increase the dose to 500mg twice daily. Depending on clinical response, the dose may be increased by 500mg/day [250mg per dose, twice daily] every 2 weeks. The maximum dose is 3000mg/day [1500mg per dose, twice daily]. Adjunctive therapy 1. Partial-onset seizures Adults (18 years and older) Treatment with this medicine is initiated at 500mg twice daily. Depending on clinical response and tolerability, the dose may be increased or decreased by 1000mg/day [500mg per dose, twice daily] every 2 to 4 weeks. The maximum recommended dose is 3000mg/day. 3. Primary generalized tonic-clonic seizures (12 years and older) Adults (18 years and older) Treatment with this medicine is initiated at 1,000mg/day [500mg per dose, twice daily]. The dose is increased by 1,000mg/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/day has not been adequately studied. 4. Patients with renal impairment Dose adjustment in adult patients with renal impairment Normal: Creatinine clearance ≧ 80 (ml/min/1.73m2), dose per administration 500-1,500mg, twice daily (12-hour intervals) Mild: Creatinine clearance 50-79 (ml/min/1.73m2), dose per administration 500-1,000mg, twice daily (12-hour intervals) Moderate: Creatinine clearance 30-49 (ml/min/1.73m2), dose per administration 250-750mg, twice daily (12-hour intervals) Severe: Creatinine clearance < 30 (ml/min/1.73m2), dose per administration 250-500mg, twice daily (12-hour intervals) End-stage renal disease patients on dialysis(1): Creatinine clearance -, dose per administration 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 dose adjustment is needed 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) Dose adjustment is recommended in elderly patients with reduced renal function.

Child dose

Monotherapy Adolescents 16 years of age and older The initial dose is 250mg twice daily. After 2 weeks, increase the dose to 500mg twice daily. Depending on clinical response, the dose may be increased by 500mg/day [250mg per dose, twice daily] every 2 weeks; the maximum dose is 3000mg/day [1500mg per dose, twice daily]. Adjunctive therapy 1. Partial-onset seizures Adolescents weighing 50kg or more (12~17 years) Treatment with this medicine is initiated at 500mg twice daily. Depending on clinical response and tolerability, the dose may be increased or decreased by 1000mg/day [500mg per dose, twice daily] every 2 to 4 weeks; the maximum recommended dose is 3000mg/day. Children 4~11 years of age and adolescents weighing less than 50kg (12~17 years) The initial dose is 10mg/kg twice daily. Depending on clinical response and tolerability, the dose may be increased to 60mg/kg/day [30mg/kg per dose, twice daily]. Dose adjustments should not exceed increases or decreases of 20mg/kg/day [10mg/kg per dose, twice daily] every 2 weeks. Use the lowest effective dose. The dose for children weighing 50kg or more is the same as the adult dose. 15-20kg(1): 20mg/kg/day (twice daily) 300mg-400mg/day [150-200mg per dose twice daily]; 40mg/kg/day (twice daily) 600mg-800mg/day [300-400mg per dose twice daily]; 60mg/kg/day (twice daily) 900mg-1,200mg/day [450-600mg per dose twice daily] 20.1-40kg: 20mg/kg/day (twice daily) 500mg/day [250mg per dose, twice daily]; 40mg/kg/day (twice daily) 1,000mg/day [500mg per dose, twice daily]; 60mg/kg/day (twice daily) 1,500mg/day [750mg per dose, twice daily] 40.1-50kg(2): 20mg/kg/day (twice daily) 1,000mg/day [500mg per dose, twice daily]; 40mg/kg/day (twice daily) 2,000mg/day [1,000mg per dose, twice daily]; 60mg/kg/day (twice daily) 3,000mg/day [1,500mg per dose, twice daily] (1) For children weighing 20kg or less, it is recommended to initiate treatment with the 100mg/ml oral solution. (2) The dosage and administration for children and adolescents weighing 50kg or more are the same as those for adults. 2. Myoclonic seizures in pediatric patients (12 years of age and older) Treatment with this medicine is initiated at 500mg twice daily. The dose is increased by 1,000mg/day every 2 weeks to the recommended daily dose of 3,000mg. Efficacy has not been studied at doses below 3,000mg/day. 3. Primary generalized tonic-clonic seizures (12 years of age and older) Adolescents weighing 50kg or more (12-17 years) Treatment with this medicine is initiated at 1,000mg/day [500mg per dose, twice daily]. The dose is increased by 1,000mg/day [500mg per dose, twice daily] every 2 weeks to the recommended daily dose of 3,000mg [1,500mg per dose, twice daily]. Efficacy has not been adequately studied at doses below 3,000mg/day. Adolescents weighing less than 50kg (12-17 years) Treatment with this medicine is initiated at 20mg/kg/day [10mg/kg per dose, twice daily]. The dose is increased by 20mg/kg/day [10mg/kg per dose, twice daily] every 2 weeks to the recommended daily dose of 60mg/kg [30mg/kg per dose, twice daily]. Efficacy has not been adequately studied at doses below 60mg/kg/day. 4. Patients with renal impairment ks= 0.45 (infants under 1 year of age) ks= 0.55 (children and female adolescents under 13 years of age) ks= 0.7 (male adolescents) Dose adjustment for pediatric patients and adolescents weighing less than 50kg with renal impairment Normal: Creatinine clearance ≧ 80 (ml/min/1.73m2), 10-30mg/kg(0.10-0.30 ml/kg) twice daily Mild: Creatinine clearance 50-79 (ml/min/1.73m2), 10-20mg/kg(0.10-0.20 ml/kg) twice daily Moderate: Creatinine clearance 30-49 (ml/min/1.73m2), 5-15mg/kg (0.05-0.15ml/kg) twice daily Severe: Creatinine clearance < 30 (ml/min/1.73m2), 5-10 mg/kg (0.05-0.10ml/kg) twice daily End-stage renal disease patients on dialysis: Creatinine clearance --, 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 The oral formulation is not recommended for infants under 1 month of age due to insufficient safety and efficacy data. Tablets are not indicated for children 4 years of age or younger, and the oral solution should be administered to infants 1 month of age and older. Use of the injection is not recommended in children under 16 years of age because its safety and efficacy have not been established.

This medication may increase the risk of suicidal thoughts or behaviors in patients being treated for epilepsy; therefore, patients and caregivers should closely monitor for mood changes or symptoms of depression. Additionally, this medication can cause central nervous system adverse reactions such as drowsiness, fatigue, coordination disorders, and behavioral disturbances, particularly in the first four weeks of treatment. Abruptly discontinuing the medication may worsen seizures, so the dosage must be gradually reduced as directed by a physician. Patients with an allergy to any component of this medication should not take it, and those with impaired kidney or liver function may require dose adjustments. Side effects such as a decrease in blood cell count can occur; therefore, blood tests should be conducted if unusual symptoms such as fever or weakness arise. Psychiatric adverse behaviors such as aggression, anxiety, and depression may occur, and a physician should be consulted if these changes are observed. This medication has a risk of prolonging the QT interval on an electrocardiogram, so caution is necessary in patients with heart disease or those taking related medications. Drowsiness or dizziness may occur; therefore, precautions should be taken when driving or operating machinery, especially at the start of treatment or during dose increases. The use of this medication during pregnancy should be thoroughly evaluated due to unknown effects on the fetus, and breastfeeding is discouraged as the drug may be transmitted through breast milk. Safety has not been established in pediatric patients, especially in infants less than one month old, and children under four years should be administered in liquid form. Elderly patients may be at higher risk of drug-related side effects due to decreased kidney function, so dose adjustments and caution are required. In the case of overdose, symptoms such as drowsiness, agitation, aggression, and reduced consciousness may occur, and since there is no specific antidote, symptomatic treatment and hemodialysis may be necessary. This medication has low interactions with other epilepsy treatments, oral contraceptives, digoxin, and warfarin, but caution should be exercised when used in conjunction with methotrexate due to the potential increase in blood concentration. Finally, this medication should be kept out of reach of children, and transferring it to another container is not advisable for maintaining product quality.

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

This medication should be stored in a tightly closed container to protect it from air and moisture. It is important to maintain room temperature between 1 degree and 30 degrees Celsius. This will help preserve the effectiveness of the medication for a longer period.

Appearance

Yellow oval film-coated tablets

Package unit

60 tablets (10 tablets/PTP × 6)