Levi Epileptic Tablets 500 mg (Levetiracetam)

Adult dose

The 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 administered twice daily. Levetiracetam treatment may be initiated by intravenous or oral administration. When changing the route of administration from oral to intravenous or vice versa, the change may be made directly without dose titration; the total daily dose and frequency of administration should remain the same. Monotherapy — Adults and 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 daily dose may be increased by 500mg [250mg per dose, twice daily] every 2 weeks. The maximum dose is 3000mg daily [1500mg per dose, twice daily]. Adjunctive therapy — Partial-onset seizures — Adults (18 years of age and older) and adolescents weighing 50kg or more (12~17 years of age) Start treatment with 500mg twice daily. Depending on clinical response and tolerability, the daily dose may be increased or decreased by 1000mg [500mg per dose, twice daily] every 2 to 4 weeks. The maximum recommended dose is 3000mg daily. Adjunctive therapy — Primary generalized tonic-clonic seizures — Adults (18 years of age and older) and adolescents weighing 50kg or more (12-17 years of age) Start treatment with 1,000mg daily [500mg per dose, twice daily]. Increase the dose by 1,000mg daily [500mg per dose, twice daily] every 2 weeks to the recommended daily dose of 3,000mg [1,500mg per dose, twice daily]. Efficacy at doses below 3,000mg daily has not been adequately studied. Patients with renal impairment: Since levetiracetam clearance is related to renal function, adjust the dose individually according to the patient's renal function. Refer to the table below for dosage adjustment in adults. Dosage adjustment in adult patients with renal impairment Normal (creatinine clearance ≧ 80 ml/min/1.73m2): 500-1,500mg per dose, twice daily (12-hour interval) Mild (50-79 ml/min/1.73m2): 500-1,000mg per dose, twice daily (12-hour interval) Moderate (30-49 ml/min/1.73m2): 250-750mg per dose, twice daily (12-hour interval) Severe (< 30 ml/min/1.73m2): 250-500mg per dose, twice daily (12-hour interval) 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. Thereafter, adjust CLcr according to body surface area (BSA) as follows. 5. Patients with hepatic impairment No dosage adjustment is required in patients with mild to moderate hepatic impairment. In patients with severe hepatic impairment, creatinine clearance may underestimate renal impairment. Therefore, when creatinine clearance is less than 60ml/min/1.73m2, it is recommended that the daily maintenance dose be reduced by 50%. 7. Older adults (65 years of age and older) Dose adjustment is recommended in older patients with reduced renal function.

Child dose

Adjunctive therapy — Partial-onset seizures — Children 4~11 years of age and adolescents 12~17 years of age 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 daily [30mg/kg per dose, twice daily]. Dose changes should not exceed an increase or decrease of 20mg/kg daily [10mg/kg per dose, twice daily] every 2 weeks. Use the lowest effective dose. Recommended doses for children and adolescents — 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] Recommended doses for children and adolescents — 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] Recommended doses for children and adolescents — 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 for adults. Adjunctive therapy — Myoclonic seizures in pediatric patients (12 years of age and older) Start treatment with 500mg twice daily. Increase the dose by 1,000mg daily every 2 weeks to the recommended daily dose of 3,000mg. Efficacy at doses below 3,000mg daily has not been studied. Adjunctive therapy — Primary generalized tonic-clonic seizures — Adolescents 12-17 years of age weighing less than 50kg Start treatment at 20mg/kg daily [10mg/kg per dose, twice daily]. Increase the dose by 20mg/kg daily [10mg/kg per dose, twice daily] every 2 weeks to the recommended daily dose of 60mg/kg [30mg/kg per dose, twice daily]. Efficacy at doses below 60mg/kg daily has not been adequately studied. 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 (50-79 ml/min/1.73m2): 10-20mg/kg (0.10-0.20 ml/kg) twice daily Moderate (30-49 ml/min/1.73m2): 5-15mg/kg (0.05-0.15ml/kg) twice daily Severe (< 30 ml/min/1.73m2): 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. ks= 0.45 (infants under 1 year of age) ; ks= 0.55 (children under 13 years of age and female adolescents) ks= 0.7 (male adolescents) 6. Children Oral formulations are not recommended for infants under 1 month of age because of insufficient safety and efficacy data. Tablets are not indicated for children under 4 years of age; the oral solution should be administered to infants 1 month of age and older. Injection is not recommended in children under 16 years of age because its safety and efficacy have not been established.

This drug is a medication used for the treatment of epilepsy, and there may be an increased risk of suicidal thoughts or behaviors during treatment; therefore, patients and caregivers should carefully monitor for these symptoms. Additionally, this drug may cause neurological and psychiatric side effects such as drowsiness, fatigue, coordination impairment, and behavioral changes, especially during the first 4 weeks of treatment. Discontinuation of the drug should not be done abruptly as it may exacerbate seizures; hence, dosage must be gradually reduced according to the physician's instructions. Patients allergic to the active ingredient or any components of this drug should not take it. Patients with depression or suicidal thoughts should inform their doctor immediately, and those with impaired kidney function may require dosage adjustments. Various side effects such as decreased blood cell count, unusual behavior, aggression, worsening seizures, and cardiac rhythm abnormalities have been reported; if such symptoms occur, medical attention should be sought immediately. During therapy, continuous monitoring of mental state and mood changes is necessary, and if severe behavioral changes occur, dosage adjustments or discontinuation may be considered. Women who are pregnant or planning to become pregnant should consult a specialist before use, and breastfeeding mothers should consider cessation of breastfeeding or drug changes, as this medication may be excreted in breast milk and affect the baby. Careful dosage adjustments are necessary for children and the elderly, and safety has not been established for infants less than 1 month old. Caution should be taken when performing tasks that require concentration, such as driving or operating machinery, as drowsiness or dizziness may occur after taking this medication. In cases of overdose, symptoms may include drowsiness, aggression, and decreased consciousness; immediate emergency care should be sought, and since no specific antidote exists, treatments like hemodialysis may be required. This drug generally has few interactions with other medications; however, care must be taken when taken with specific medications, so inform the healthcare provider of any other medications being taken. Finally, this medication should be kept out of the reach of children, and it is safe not to transfer it to another container.

• suicidal ideation
• suicidal behavior
• depression
• abnormal mood and behavior changes
• drowsiness
• fatigue
• coordination movement disorders
• behavioral abnormalities
• lethargy
• ataxia

This drug should be stored in a tightly closed container that protects it from air and moisture, and the temperature should be kept between 1 to 30 degrees Celsius at room temperature. Proper storage will maintain the effectiveness of the drug and allow for safe use.

Appearance

Yellow oval film-coated tablet

Package unit

120 tablets/bottle, 30 tablets/bottle