Epilatam 500mg (Levetiracetam)

Adult dose

Film-coated tablets and oral solution are administered orally and may be taken with or without food, with plenty of water. The daily dose should be divided into 2 equal doses and administered twice daily. Levetiracetam treatment may be initiated intravenously or orally. When switching from oral to intravenous administration or vice versa, the dose may be given directly without titration; the total daily dose and frequency of administration should remain the same. 1. Monotherapy and adjunctive therapy for partial-onset seizures (aged 4 years and older) Adults (18 years and older) Start this medicine 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 (aged 12 years and older) Efficacy at doses below 3,000mg per day has not been studied. 3. Adjunctive therapy for primary generalized tonic-clonic seizures (aged 12 years and older) Adults (18 years and older) Start this medicine at 1,000mg per day [500mg per dose, twice daily]. Increase the dose 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, individualize the dose according to the patient's renal function. Refer to the table below for dose adjustment in adults. To use the table, the patient's creatinine clearance (CLCr, ml/min) is required. In adults, it can be calculated from the serum creatinine (mg/dl) value using the formula below. Dose adjustment for adult patients with renal impairment Normal: creatinine clearance ≧ 80 (ml/min/1.73m2), single dose 500-1,500mg, twice daily (12-hour interval) Mild: creatinine clearance 50-79 (ml/min/1.73m2), single dose 500-1,000mg, twice daily (12-hour interval) Moderate: creatinine clearance 30-49 (ml/min/1.73m2), single dose 250-750mg, twice daily (12-hour interval) Severe: creatinine clearance < 30 (ml/min/1.73m2), single dose 250-500mg, twice daily (12-hour interval) End-stage renal disease patients on dialysis (1): creatinine clearance -, single dose 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 required in patients with mild to moderate hepatic impairment. In patients with severe hepatic impairment, creatinine clearance may underestimate renal insufficiency. Therefore, when creatinine clearance is less than 60mL/min/1.73m2, it is advisable to reduce the daily maintenance dose by 50%. 7. Elderly patients (65 years and older) Dose adjustment is recommended in elderly patients with impaired renal function.

Child dose

1. Monotherapy and adjunctive therapy for partial-onset seizures (4 years and older) Adolescents weighing 50kg or more (12~17 years): Treatment is initiated with 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. Children aged 4~11 years and adolescents aged 12~17 years weighing less than 50kg: The initial dose is 10mg/kg twice daily. Depending on clinical response and tolerability, the dose may be increased up to 60mg/kg per day [30mg/kg twice daily]. Dose adjustments should not exceed increases or decreases 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 initiated with 500mg per day [250mg twice daily], and the dose 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 initiated with 1000mg per day [500mg twice daily], and the dose 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: Same as the adult dosage. 2. Adjunctive therapy for myoclonic seizures in pediatric patients (12 years and older) 12 years and older: Treatment is initiated with 500mg twice daily. The dose is increased by 1,000mg per day every 2 weeks 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) Adolescents weighing 50kg or more (12-17 years): Treatment is initiated with 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 at doses below 3,000mg per day has not been adequately studied. Adolescents aged 12-17 years weighing less than 50kg: Treatment is initiated with 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 at doses below 60mg/kg per day has not been adequately studied. Dosage adjustment for pediatric patients and adolescents weighing less than 50kg with renal impairment Normal: Creatinine clearance ≧ 80 (ml/min/1.73m2), dose and administration per dose 10-30mg/kg (0.10-0.30 ml/kg) twice daily Mild: Creatinine clearance 50-79 (ml/min/1.73m2), dose and administration per dose 10-20mg/kg (0.10-0.20 ml/kg) twice daily Moderate: Creatinine clearance 30-49 (ml/min/1.73m2), dose and administration per dose 5-15mg/kg (0.05-0.15ml/kg) twice daily Severe: Creatinine clearance < 30 (ml/min/1.73m2), dose and administration per dose 5-10 mg/kg (0.05-0.10ml/kg) twice daily End-stage renal disease patients on dialysis: Creatinine clearance --, dose and administration per dose 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. ks= 0.45 (infants under 1 year) ; ks= 0.55 (children under 13 years and female adolescents) ks= 0.7 (male adolescents) 6. Children The oral formulation is not recommended for infants under 1 month because of insufficient safety and efficacy data. Tablet administration is not applicable to children 4 years or younger, and the oral solution should be administered to infants 1 month and older. The injection is not recommended for children under 16 years because its safety and efficacy have not been established.

This medication is used for the treatment of epilepsy and may increase the risk of suicidal thoughts or behaviors, so mood changes or unusual behavioral changes should be carefully monitored during use. During the first 4 weeks, symptoms such as drowsiness, fatigue, coordination disturbances, and behavioral abnormalities may often occur, especially in children and patients over 6 years old, where behavioral disturbances have been reported. Abrupt discontinuation of this medication may worsen seizures, so the dosage should be gradually reduced according to the physician's instructions. Patients allergic to any component of this medication should not take it, and any occurrence of suicidal thoughts or depression symptoms should be reported to healthcare providers immediately. Patients with impaired kidney function may require dosage adjustments, and there is a possibility of side effects including decreased blood cell counts, so they should undergo examinations if symptoms appear. This medication may also induce behavioral changes such as psychotic symptoms, aggression, and irritability, so if these symptoms occur, consultation with a physician is necessary. Increased dosing or at the beginning of treatment may cause seizures to worsen, so caution is needed. Patients with heart disease or at risk for QT interval prolongation should undergo an electrocardiogram. Drowsiness or dizziness may occur during treatment, hence caution is advised while driving or operating dangerous machinery. Women who are pregnant or planning to become pregnant should consult their healthcare provider, and during breastfeeding, as this medication can be excreted into breast milk and affect the baby, it is recommended to consider discontinuing breastfeeding or the medication. Special caution is required when administering to children or elderly patients, and safety has not been established in infants under 1 month of age. In the case of overdose, symptomatic treatment should be provided, as there is no antidote for this medication. Consideration should be given to potential interactions with other medications during use, especially attention should be paid when used with methotrexate as it may increase blood concentrations. There is no data on interaction with alcohol, so it is advisable to avoid alcohol consumption. This medication should be kept out of reach of children, and transferring it to another container is not recommended as it may lead to accidents.

• suicidal ideation
• suicidal behavior
• depression
• abnormal mood and behavioral changes
• drowsiness
• fatigue
• akathisia
• behavioral abnormalities
• lethargy
• psychotic symptoms

This medication should be stored in a tightly sealed container to protect it from air and moisture. A storage temperature between 1 degree and 30 degrees Celsius is recommended to maintain the drug's efficacy.

Appearance

Yellow oval film-coated tablet

Package unit

120 tablets/bottle, 30 tablets/bottle