Epileptam 250 mg (Levetiracetam)

Adult dose

Film-coated tablets and oral solution are administered orally and may be taken with or without food, with a sufficient amount of water. The total daily dose is 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, the medication may be administered immediately without dose titration; the total daily dose and dosing frequency should remain the same. Monotherapy and adjunctive therapy for partial-onset seizures (4 years and older): Adults (18 years and older) and adolescents weighing 50 kg or more (12~17 years) — Treatment with this medication is started at 500mg twice daily. Depending on clinical response and tolerability, the dose may be increased or decreased by 1000mg per day [500mg twice daily] every 2 to 4 weeks; the maximum recommended dose is 3000mg per day. Adjunctive therapy for myoclonic seizures in pediatric patients (12 years and older): Treatment with this medication is started at 500mg twice daily. The dose is increased by 1,000mg per day every 2 weeks to the recommended daily dose of 3,000mg. Efficacy has not been studied at doses below 3,000mg per day. Adjunctive therapy for primary generalized tonic-clonic seizures (12 years and older): Adults (18 years and older) and adolescents weighing 50 kg or more (12-17 years) — Treatment with this medication is started at 1,000mg per day [500mg twice daily]. The dose is increased by 1,000mg per day [500mg twice daily] every 2 weeks to the recommended daily dose of 3,000mg [1,500mg twice daily]. Efficacy has not been adequately studied at doses below 3,000mg per day. 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 dose adjustment in adults. Dose adjustment in adult patients with renal impairment — Normal, creatinine clearance ≧ 80 ml/min/1.73m2: 500-1,500mg per dose, twice daily (12-hour intervals) Mild, creatinine clearance 50-79 ml/min/1.73m2: 500-1,000mg per dose, twice daily (12-hour intervals) Moderate, creatinine clearance 30-49 ml/min/1.73m2: 250-750mg per dose, twice daily (12-hour intervals) Severe, creatinine clearance < 30 ml/min/1.73m2: 250-500mg per dose, twice daily (12-hour intervals) End-stage renal disease patients on dialysis(1), creatinine clearance -: 500-1,000mg per dose, once daily(2) (1) An initial loading dose of 750mg is recommended on the first day of treatment. (2) After dialysis, an additional dose of 250-500mg is recommended. Patients with hepatic impairment: No dose 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%. Older adults (65 years and older): Dose adjustment is recommended in older patients with reduced renal function.

Child dose

Monotherapy and adjunctive therapy for partial-onset seizures (4 years and older) Children aged 4 to 11 years and adolescents aged 12~17 years weighing less than 50 kg: The initial dose is 10mg/kg twice daily. Depending on clinical response and tolerability, the dose may be increased to 60mg/kg per day [30mg/kg twice daily]; dose changes should not exceed an increase or decrease of 20mg/kg per day [10mg/kg twice daily] every 2 weeks. Use the lowest effective dose. The maximum recommended dose is 3000mg per day. Children weighing 20kg or less: It is recommended to initiate treatment with the 100mg/ml oral solution. Children weighing 20~40kg: Treatment is started at 500mg per day [250mg twice daily] and may be increased by 500mg per day every 2 weeks, up to a maximum of 1500mg per day [750mg twice daily]. Children weighing more than 40kg: Treatment is started at 1000mg per day [500mg twice daily] and may be increased by 1000mg per day every 2 weeks, up to a maximum of 3000mg per day [1500mg twice daily]. Children weighing 50kg or more: The dose is the same as the adult dose. Adjunctive therapy for myoclonic seizures in pediatric patients (12 years and older) Adolescents aged 12-17 years weighing less than 50kg: Treatment with this medication is started at 20mg/kg per day [10mg/kg twice daily]. The dose is increased by 20mg/kg per day [10mg/kg twice daily] every 2 weeks to the recommended daily dose of 60mg/kg [30mg/kg twice daily]. Efficacy has not been adequately studied at doses below 60mg/kg per day. Dose 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) per dose, twice daily Mild, creatinine clearance 50-79 (ml/min/1.73m2): 10-20mg/kg (0.10-0.20 ml/kg) per dose, twice daily Moderate, creatinine clearance 30-49 (ml/min/1.73m2): 5-15mg/kg (0.05-0.15ml/kg) per dose, twice daily Severe, creatinine clearance < 30 (ml/min/1.73m2): 5-10 mg/kg (0.05-0.10ml/kg) per dose, twice daily End-stage renal disease patients on dialysis, creatinine clearance --: 10-20mg/kg (0.10-0.20 ml/kg) per dose, once daily(1)(2) (1) A loading dose of 15 mg/kg (0.15ml/kg) is recommended on the first day of treatment. (2) After dialysis, an additional dose of 5-10 mg/kg (0.05-0.10ml/kg) is recommended. Infants under 1 year: ks= 0.45 Children and adolescents under 13 years who are female: ks= 0.55 Adolescent males: ks= 0.7 Children: The oral formulation is not recommended for infants under 1 month due to insufficient safety and efficacy data. Infants 1 month and older: The oral solution should be administered. Children 4 years and younger: Tablet administration is not applicable. Children under 16 years: Use of the injection is not recommended because its safety and efficacy have not been established.

This medication is used for the treatment of epilepsy and there is a risk of developing mental health issues such as suicidal thoughts, suicidal behavior, and depression during use. Therefore, if there are changes in mood or behavior while taking this medication, medical personnel should be informed immediately. This medication may cause neurological side effects such as drowsiness, fatigue, coordination disorders, and behavioral abnormalities, especially within the first 4 weeks of administration. As seizures may worsen, do not abruptly discontinue the medication; dosage should be reduced gradually as advised by a physician. Patients who are allergic to this drug or its components should not take it. Patients with impaired kidney function or severely damaged liver function require dosage adjustment and should undergo blood tests to check for abnormalities. Psychiatric symptoms such as changes in behavior, aggression, and irritability may appear, and medical personnel should be consulted if these symptoms occur. Caution is needed for patients with heart disease or prolonged QT interval on an ECG. Women who are pregnant or planning to become pregnant should consult medical personnel before taking the medication, and nursing mothers should consider stopping breastfeeding or discontinuing the medication as it may pass into breast milk. Children and the elderly should also exercise caution while taking this medication; the safety of this drug has not been established for infants under 1 month. Caution is advised when driving or operating machinery due to potential drowsiness or dizziness. In case of overdose, immediate emergency treatment is required, and the drug can be removed through hemodialysis. Store the medication out of reach of children and do not transfer it to other containers.

• suicidal thoughts
• suicidal behavior
• depression
• abnormal mood and behavior changes
• drowsiness
• fatigue
• akathisia
• behavioral abnormalities
• weakness
• aggression

This medication should be stored in a tightly closed container to avoid exposure to air or moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness and safety.

Appearance

Blue oval film-coated tablets

Package unit

30 tablets/bottle