Levira Tablet 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 total 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, the route of administration may be changed directly without dose titration; the total daily dose and frequency of administration should remain the same. Monotherapy and adjunctive therapy for partial-onset seizures: Adults (18 years of age and older) and adolescents weighing 50kg or more (12~17 years) Start this medicine at 500mg twice daily. However, based on the physician's assessment of potential adverse reactions relative to seizure reduction, the initial dose may be lowered 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 per dose, twice daily] or 1000mg/day [500mg per dose, twice daily], up to the maximum recommended dose of 3000mg/day [1500mg per dose, twice daily]. Patients with renal impairment: Since levetiracetam clearance is related to renal function, administer the medicine individually according to the patient's renal function. Refer to the table below for dose adjustment in adults. 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 administration. (2) An additional dose of 250-500mg is recommended after dialysis. 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 impairment. 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 of age and older): Dose adjustment is recommended in older patients with reduced renal function.

Child dose

1. Monotherapy and adjunctive therapy for partial-onset seizures (4 years and older) ▪ Children 4–11 years of age and adolescents 12–17 years of age 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/day [30mg/kg per dose, twice daily]. Dose increases or decreases should not exceed 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 start treatment with the 100mg/ml oral solution. Children weighing 20~40kg: Start 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: Start 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. ▪ Adults (18 years and older) and adolescents 12–17 years of age weighing 50kg or more: For the dose applicable to adolescents 12–17 years of age, see adultDosage. 2. Adjunctive therapy for myoclonic seizures in pediatric patients (12 years and older) Treatment 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 per dose, twice daily] or 1000mg/day [500mg per dose, twice daily], and the maximum recommended dose is 3000mg/day [1500mg per dose, 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) ▪ Adolescents 12-17 years of age weighing less than 50kg: Treatment 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. 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. ks= 0.45 (infants under 1 year) ks= 0.55 (children under 13 years and female adolescents) ks= 0.7 (male adolescents) Children: Oral formulations are not recommended for infants under 1 month because of insufficient safety and efficacy data. Tablets are not applicable to children 4 years of age or younger; infants 1 month and older should receive the oral solution. 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 there is a risk of serious mental health issues such as suicidal thoughts or behavior during use. Therefore, patients or caregivers should immediately inform healthcare providers if signs of depression, mood changes, or unusual behaviors occur. This medication can affect the central nervous system, causing drowsiness, fatigue, coordinating movement disorders, and behavioral disturbances, particularly within the first four weeks. Neuropsychiatric adverse reactions have been reported in both children and adults. Discontinuing the medication suddenly may worsen seizures, so dosages must be gradually reduced following a doctor's instructions. Patients allergic to any components of this medication should not take it. Special care is needed for patients with suicidal ideation or depressive symptoms, poor kidney function, reduced blood cell counts, or who exhibit behavioral abnormalities or aggression. Additionally, this medication can worsen seizures; if any abnormal symptoms occur, consult a physician immediately. Patients with heart issues or prolonged QT intervals need to exercise caution when taking this medication. Pregnant women or those planning to become pregnant must consult their doctor before taking this medication, and mothers who are breastfeeding should discuss with their doctor whether to discontinue breastfeeding or the medication, as the drug can pass into breast milk and affect the baby. This medication should not be used in children, especially infants under 1 month, as safety has not been established, and children under 4 years should only take it in liquid form. Elderly patients may require dosage adjustments due to potential decreased kidney function. Care should be taken when driving or operating machinery, as drowsiness or reduced concentration may occur. In the event of an overdose, symptoms may include drowsiness, agitation, aggression, and altered consciousness, requiring immediate medical attention. Although this medication has fewer drug interactions, caution is needed when taken with specific other drugs, so it is important to inform healthcare providers about all medications being taken. If symptoms such as rash, fever, lymph node swelling arise during treatment, inform healthcare providers immediately, as there is a risk of serious hypersensitivity reactions like DRESS syndrome. Therefore, it is essential to follow healthcare providers' instructions closely while taking this medication and to consult with them immediately if any abnormal symptoms occur.

• suicidal ideation
• suicidal behavior
• depression
• drowsiness
• fatigue
• coordination motor disturbances
• behavioral abnormalities
• asthenia
• aggression
• restlessness

This medication should be stored in a tightly closed container to protect from air and moisture. The recommended storage temperature is room temperature between 1 and 30 degrees Celsius.

Appearance

Yellow oval film-coated tablets

Package unit

60 tablets/box [10 tablets/PTPX6]