Keppra 1000mg (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 and adolescents 16 years 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, partial-onset seizures: Adults (18 years and older) and 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. Adjunctive therapy, primary generalized tonic-clonic seizures: Adults (18 years and older) and 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, 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. Patients with renal impairment: Dose adjustment in adult patients with renal impairment: Normal, ≧ 80, 500-1,500mg per dose, twice daily (12-hour intervals). Mild, 50-79, 500-1,000mg per dose, twice daily (12-hour intervals). Moderate, 30-49, 250-750mg per dose, twice daily (12-hour intervals). Severe, < 30, 250-500mg per dose, twice daily (12-hour intervals). End-stage renal disease patients on dialysis(1), -, 500-1,000mg per dose, 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. 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%. Elderly patients (65 years and older): Dose adjustment is recommended in elderly patients with reduced renal function.

Child dose

Adjunctive therapy, partial-onset seizures: Children aged 4 to 11 years and adolescents aged 12 to 17 years weighing less than 50kg: The initial dose is 10mg/kg per dose twice daily. Depending on clinical response and tolerability, the dose may be increased up to 60mg/kg/day [30mg/kg per dose, twice daily]. Dose changes should not exceed an increase or decrease 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. Body weight 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] Body weight 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] Body weight 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 that treatment be initiated with the 100mg/ml oral solution. (2) The dosage and administration for children and adolescents weighing 50kg or more are the same as for adults. Myoclonic seizures in pediatric patients (12 years and older): Treatment with this medicine is initiated at 500mg twice daily. The dose is increased by 1,000mg/day every 2 weeks, up to the recommended daily dose of 3,000mg. Efficacy at doses below 3,000mg/day has not been studied. Primary generalized tonic-clonic seizures: Adolescents aged 12-17 years weighing less than 50kg: 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, up to the recommended daily dose of 60mg/kg [30mg/kg per dose, twice daily]. Efficacy at doses below 60mg/kg/day has not been adequately studied. ks= 0.45 (infants under 1 year) ; ks= 0.55 (children and female adolescents under 13 years) ks= 0.7 (male adolescents) Dose adjustment in 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. Oral formulations are not recommended for infants under 1 month because of insufficient safety and efficacy data. Tablet administration is not applicable to children 4 years and younger; the oral solution should be administered to infants 1 month and older. Injection is not recommended for children under 16 years because its safety and efficacy have not been established.

This medication is used for treating epilepsy, and patients must be closely monitored for mental health issues such as suicidal thoughts, suicidal behavior, and depression during treatment. Taking this medication may lead to drowsiness, fatigue, coordination problems, and behavioral abnormalities, especially within the first 4 weeks, requiring particular caution. Abruptly stopping the medication may worsen seizures, so it is essential to gradually reduce the dosage under medical supervision. Do not take this medication if you have hypersensitivity or allergies to its components. If suicidal thoughts or depressive symptoms occur, notify healthcare providers immediately, and dosage adjustments may be necessary for patients with impaired kidney function. Blood tests are required to check for abnormalities such as leukopenia or thrombocytopenia. This medication may induce behavioral changes or psychiatric symptoms such as aggression; consult a physician if such symptoms appear. Caution is needed as seizures may worsen initially or with increased dosage during treatment. Patients with heart conditions or prolonged QT intervals on EKG should exercise caution while taking this medication. Drowsiness or dizziness may occur during treatment, thus it is advisable to avoid driving or operating hazardous machinery. Women who are pregnant or plan to become pregnant should consult a healthcare professional before taking this medication, and nursing mothers may need to consider stopping breastfeeding or discontinuing the medication. Cautiously monitor dosage and side effects when using in children or elderly patients.

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

This medication may be sensitive to air or moisture and should be stored in a tightly sealed container. It is recommended to keep storage temperature between 1 degree and 30 degrees Celsius at room temperature.

Appearance

White oval film-coated tablets

Package unit

60 tablets/box [10 tablets/PTP × 6]