Keppra 1000 mg (Levitaracetam)

Adult dose

Film-coated tablets and oral solution are administered orally and may be taken with or without food. Take with plenty of water. The daily dose should be divided into 2 equal doses and administered twice daily. Levetiracetam treatment may be initiated by the intravenous or oral route. When changing from oral to intravenous administration or vice versa, the medication may be given immediately without dose titration, and 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) Treatment with this drug is initiated at 500mg twice daily. However, based on the physician's assessment of potential adverse reactions relative to seizure reduction, the initial dose may be reduced to 250mg twice daily and increased to 500mg twice daily after 2 weeks. Depending on clinical response and tolerability, the dose may be increased or decreased every 2 to 4 weeks by 500mg/day [250mg twice daily] or 1000mg/day [500mg twice daily], with a maximum recommended dose of 3000mg/day [1500mg twice daily]. 2. Adjunctive therapy for myoclonic seizures in pediatric patients (12 years and older) Treatment with this drug is initiated at 500mg twice daily. However, based on the physician's assessment of potential adverse reactions relative to seizure reduction, the initial dose may be reduced to 250mg twice daily and increased to 500mg twice daily after 2 weeks. Depending on clinical response and tolerability, the dose may be increased or decreased every 2 weeks by 500mg/day [250mg twice daily] or 1000mg/day [500mg twice daily], with a maximum recommended dose of 3000mg/day [1500mg twice daily]. Efficacy at doses below 3,000mg/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) Treatment with this drug is initiated at 1,000mg/day [500mg twice daily]. However, based on the physician's assessment of potential adverse reactions relative to seizure reduction, the initial dose may be reduced to 250mg twice daily and increased to 500mg twice daily after 2 weeks. Depending on clinical response and tolerability, the dose may be increased or decreased every 2 weeks by 500mg/day [250mg twice daily] or 1000mg/day [500mg twice daily], with a maximum recommended dose of 3000mg/day [1500mg twice daily]. Efficacy at doses below 3,000mg/day has not been adequately studied. 4. Patients with renal impairment Because levetiracetam clearance is related to renal function, administer the drug individually according to the patient's renal function. Refer to the table below for dosage adjustments in adults. To use the table, the patient's creatinine clearance (CLCr,ml/min) value is required. In adults, this can be calculated from the serum creatinine (mg/dl) level using the formula below. Thereafter, adjust CLcr according to body surface area (BSA) as shown below. Dosage adjustment for adult patients with renal impairment Normal: Creatinine clearance ≧ 80 ml/min/1.73m2, dose per administration 500-1,500mg, twice daily (12-hour interval) Mild: Creatinine clearance 50-79 ml/min/1.73m2, dose per administration 500-1,000mg, twice daily (12-hour interval) Moderate: Creatinine clearance 30-49 ml/min/1.73m2, dose per administration 250-750mg, twice daily (12-hour interval) Severe: Creatinine clearance < 30 ml/min/1.73m2, dose per administration 250-500mg, twice daily (12-hour interval) 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 dosage adjustment is necessary in patients with mild to moderate hepatic impairment. In patients with severe hepatic impairment, creatinine clearance may underestimate renal failure. 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

1. Monotherapy and adjunctive therapy for partial-onset seizures (4 years and older) 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 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 maximum recommended dose is 3000mg/day. Children weighing 20kg or less: It is recommended to initiate treatment with the 100mg/ml oral solution. Children weighing 20 to 40kg: Initiate treatment at 500mg/day [250mg per dose, twice daily]; the dose may be increased by 500mg/day every 2 weeks, up to a maximum of 1500mg/day [750mg per dose, twice daily]. Children weighing more than 40kg: Initiate treatment at 1000mg/day [500mg per dose, twice daily]; the dose may be increased by 1000mg/day every 2 weeks, up to a maximum of 3000mg/day [1500mg per dose, twice daily]. Children weighing 50kg or more: The dose is the same as the adult dose. 3. Adjunctive therapy for primary generalized tonic-clonic seizures (12 years and older) 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 to the recommended daily dose of 60mg/kg/day [30mg/kg per dose, twice daily]. Efficacy at doses below 60mg/kg/day has not been adequately studied. 4. Patients with renal impairment For infants, children, and adolescents, use the following formulas. ks= 0.45 (infants under 1 year); ks= 0.55 (children and female adolescents under 13 years) ks= 0.7 (male adolescents) Dosage adjustment in 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. Pediatric patients The oral formulation is not recommended for infants under 1 month of age because of insufficient safety and efficacy data. Tablets are not indicated for children 4 years and younger; the oral solution should be administered to infants 1 month and older. The injection is not recommended for children under 16 years of age because its safety and efficacy have not been established.

This medication is used in the treatment of epilepsy. During treatment with this drug, there may be changes such as suicidal thoughts or behaviors, or symptoms of depression; therefore, patients and caregivers should inform healthcare providers immediately if such changes occur. Neuropsychiatric side effects such as drowsiness, fatigue, coordination impairment, and behavioral changes may often occur during the early stages of treatment. Do not abruptly stop taking this medication; dosage should be gradually reduced under medical supervision to prevent exacerbation of seizures. Patients who are allergic to this drug or similar compounds should not take it. Dosing adjustments may be necessary for patients with reduced kidney function, and kidney function tests are recommended before administration in those with severely impaired liver function. Because there may be symptoms of reduced blood cell counts, blood tests should be performed if fever or lethargy occurs. This medication can cause behavioral changes or psychiatric symptoms such as irritability or aggression; if abnormal behaviors are observed, consultation with a physician is necessary. Increase in dosage or initial administration may cause seizures to worsen, so caution is required. Patients with cardiovascular diseases or those with prolonged QT interval on ECG should be cautious when taking this medication. Women who are pregnant or planning to become pregnant should discuss the use of this medication with their healthcare provider; nursing mothers should consider stopping breastfeeding or discontinuing the medication as it may pass into breast milk and affect the baby. The safety of this medication has not been established in infants under 1 month and the liquid form should be administered to children under 4 years of age; safety is not established for injectable forms in those under 16 years. Elderly patients should carefully consider dosages due to an increased risk of side effects from reduced kidney function. Drowsiness or dizziness may occur with this medication; caution is advised when driving or operating machinery. In the event of overdose, vomiting or gastric lavage should be performed to remove the drug, and since there is no specific antidote, supportive care based on symptoms is necessary. This medication has relatively few drug interactions with other antiepileptic drugs or oral contraceptives, warfarin, digoxin, etc. Finally, it is safest to keep this medication out of reach of children and not to transfer it into other containers.

• Suicidal impulses
• suicidal behavior
• depression
• abnormal changes in mood and behavior
• drowsiness
• fatigue
• coordination disorders
• abnormal behavior
• weakness
• behavioral disorders

This medication should be stored in a tightly sealed container to protect it from air or moisture. Additionally, it is recommended to store the medicine at room temperature between 1 and 30 degrees Celsius, away from extreme heat or cold.

Appearance

White oval film-coated tablet

Package unit

60 tablets (10 tablets * 6 PTP)