Levirotin Tablet 500mg (Levetiracetam)

Adult dose

Film-coated tablets and oral solution are administered orally, may be taken with or without food, and should be taken with plenty of water. The daily dose is divided into 2 equal doses administered twice daily. Levetiracetam treatment may be initiated by intravenous or oral administration. When switching from oral to intravenous administration or vice versa, the medicine may be administered immediately without dose titration; the total daily dose and frequency of administration should remain the same. Adults and adolescents 16 years and older: Start with an initial dose of 250mg twice daily, and increase to 500mg twice daily after 2 weeks. Depending on clinical response, the dose may be increased every 2 weeks by 500mg daily [250mg per dose, twice daily]; the maximum dose is 3000mg daily [1500mg per dose, twice daily]. Adults (18 years and older) and adolescents (12~17 years) weighing 50kg or more: Start this medicine at 500mg twice daily. Depending on clinical response and tolerability, the dose may be increased or decreased every 2 to 4 weeks by 1000mg daily [500mg per dose, twice daily]. The maximum recommended dose is 3000mg daily. Adults (18 years and older) and adolescents (12-17 years) weighing 50kg or more: Start this medicine at 1,000mg daily [500mg per dose, twice daily]. Increase the dose every 2 weeks by 1,000mg daily [500mg per dose, twice daily] up 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. 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 undergoing 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) An additional dose of 250-500mg is recommended after dialysis. No dose adjustment is required 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 and older): Dose adjustment is recommended in older patients with reduced renal function.

Child dose

Partial-onset seizures, children 4~11 years and adolescents 12~17 years weighing less than 50kg: Start with an initial dose of 10mg/kg per dose twice daily. Depending on clinical response and tolerability, the dose may be increased to 60mg/kg daily [30mg/kg per dose, twice daily]. Dose changes must not exceed an increase or decrease of 20mg/kg daily [10mg/kg per dose, twice daily] every 2 weeks. Use the lowest effective dose. For children weighing 50kg or more, the adult dose applies. Weight 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] Weight 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] Weight 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. Myoclonic seizures in pediatric patients (12 years and older): Start this medicine at 500mg twice daily. Increase the dose every 2 weeks by 1,000mg daily up to the recommended daily dose of 3,000mg. Efficacy at doses below 3,000mg daily has not been studied. Adolescents aged 12-17 years weighing less than 50kg, primary generalized tonic-clonic seizures: Start this medicine at 20mg/kg daily [10mg/kg per dose, twice daily]. Increase the dose every 2 weeks by 20mg/kg daily [10mg/kg per dose, twice daily] up 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. ks= 0.45 (infants under 1 year of age) ; ks= 0.55 (children and female adolescents under 13 years of age) ks= 0.7 (male adolescents) Dose adjustment in children and adolescents weighing less than 50kg with renal impairment Normal, creatinine clearance (ml/min/1.73m2) ≥ 80: 10-30mg/kg(0.10-0.30 ml/kg) twice daily Mild, creatinine clearance (ml/min/1.73m2) 50-79: 10-20mg/kg(0.10-0.20 ml/kg) twice daily Moderate, creatinine clearance (ml/min/1.73m2) 30-49: 5-15mg/kg (0.05-0.15ml/kg) twice daily Severe, creatinine clearance (ml/min/1.73m2) < 30: 5-10 mg/kg (0.05-0.10ml/kg) twice daily End-stage renal disease patients undergoing dialysis, creatinine clearance (ml/min/1.73m2) --: 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. Oral formulations are not recommended for infants under 1 month of age because of insufficient safety and efficacy data. Tablets are not appropriate for children 4 years and younger, and the oral solution should be administered to infants 1 month of age and older. The injection is not recommended for children under 16 years of age because safety and efficacy have not been established.

This medication is used for the treatment of epilepsy; patients and caregivers should closely monitor for any signs of suicidal thoughts or behavior, as the risk may increase during treatment. This medication may cause central nervous system side effects such as drowsiness, fatigue, coordination difficulties, and behavioral changes, especially frequently within the first 4 weeks after starting treatment. Discontinuing the medication abruptly may worsen seizures; therefore, it should be tapered off gradually under a doctor's guidance. Patients with known hypersensitivity to the active ingredient or any component should not take this medication. Patients with depression or suicidal thoughts must consult their doctor before taking this medication, and dosage adjustments may be necessary for patients with impaired kidney function. Cases of decreased blood cell counts, psychiatric abnormalities, aggression, worsening of seizures, and cardiac arrhythmias have been reported, so patients should inform healthcare professionals immediately if unusual symptoms occur. This medication does not have significant drug interactions with other antiepileptic drugs or oral contraceptives, digoxin, or warfarin; however, caution is advised when combined with methotrexate due to possible fluctuations in blood levels. Women who are pregnant or planning to become pregnant should consult with their healthcare providers regarding the use of this medication, and nursing mothers should carefully consider whether to breastfeed as the medication may pass into breast milk. For children, safety in infants under 1 month of age has not been established, and those under 4 years of age should receive the medication in liquid form. Elderly patients may face an increased risk of side effects due to impaired renal function, so dosages should be adjusted carefully. Caution is needed when driving or operating machinery due to potential drowsiness or decreased concentration, particularly during the early stages of treatment or when the dose is increased. In cases of overdose, symptoms such as drowsiness, agitation, aggression, decreased consciousness, respiratory depression, and coma may occur, requiring immediate emergency care; blood dialysis may be helpful. This medication should be stored in a safe place out of reach of children, and transferring it to other containers should be avoided to prevent accidents.

• suicidal thoughts
• suicidal behavior
• depression
• abnormal changes in mood and behavior
• drowsiness
• fatigue
• coordination disorders
• behavioral abnormalities
• weakness
• aggression

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is best to maintain room temperature between 1 degree and 30 degrees Celsius. This way, the effectiveness and safety of the medication can be preserved for a long time.

Appearance

Yellow oval film-coated tablet

Package unit

60 tablets (10 tablets/PTP×6), 120 tablets/bottle