Leviqur 500mg Tablets (Levetiracetam)

Adult dose

Film-coated tablets and oral solution are administered orally, with or without food, and should be taken 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 the route of administration from oral to intravenous or vice versa, treatment may be switched directly without dose titration; the total daily dose and frequency of administration should remain the same. Monotherapy — Adults and adolescents 16 years and older: Treatment is initiated at 250mg twice daily and increased to 500mg twice daily after 2 weeks. Depending on clinical response, the dose may be increased every 2 weeks by 500mg/day [250mg per dose, twice daily], up to a maximum dose of 3000mg/day [1500mg per dose, twice daily]. Adjunctive therapy — 1. Partial-onset seizures: Adults (18 years and older): Treatment with this medicine is initiated at 500mg twice daily. Depending on clinical response and tolerability, the dose may be increased or decreased every 2 to 4 weeks by 1000mg/day [500mg per dose, twice daily], up to the maximum recommended dose of 3000mg/day. 2. Myoclonic seizures in pediatric patients (12 years and older): Treatment with this medicine is initiated at 500mg twice daily. The dose is increased by 1,000mg/day every 2 weeks up to the recommended daily dose of 3,000mg. Efficacy has not been studied at doses below 3,000mg/day. 3. Primary generalized tonic-clonic seizures (12 years and older): Adults (18 years and older): Treatment with this medicine is initiated at 1,000mg/day [500mg per dose, twice daily]. The dose is increased by 1,000mg/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 has not been adequately studied at doses below 3,000mg/day. 4. 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. To use the table, the patient’s creatinine clearance (CLCr, mL/min) value is required; in adults, it can be calculated from serum creatinine (mg/dl) using the formula below. Dose adjustment in adult patients with renal impairment — Normal, ≥ 80: 500-1,500mg per dose, twice daily (12-hour intervals); Mild, 50-79: 500-1,000mg per dose, twice daily (12-hour intervals); Moderate, 30-49: 250-750mg per dose, twice daily (12-hour intervals); Severe, < 30: 250-500mg per dose, twice daily (12-hour intervals); 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. 5. 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%. 7. Elderly patients (65 years and older): Dose adjustment is recommended in elderly patients with impaired renal function.

Child dose

Adjunctive therapy — 1. Partial-onset seizures: Adolescents (12~17 years) weighing 50kg or more: This drug is initiated at 500mg twice daily. Depending on clinical response and tolerability, the dose may be increased or decreased by 1000mg/day [500mg twice daily] every 2 to 4 weeks; the maximum recommended dose is 3000mg/day. Children 4~11 years: 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 twice daily]; dose adjustments should not exceed an increase or decrease of 20mg/kg/day [10mg/kg twice daily] every 2 weeks. Use the lowest effective dose. Adolescents 12~17 years weighing less than 50kg (partial-onset seizures): 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 twice daily]; dose adjustments should not exceed an increase or decrease of 20mg/kg/day [10mg/kg twice daily] every 2 weeks. Use the lowest effective dose. Children weighing 50kg or more: The dosage is the same as the adult dosage. 15-20kg(1): 20mg/kg/day (twice daily)—300mg-400mg/day [150-200mg twice daily]; 40mg/kg/day (twice daily)—600mg-800mg/day [300-400mg twice daily]; 60mg/kg/day (twice daily)—900mg-1,200mg/day [450-600mg twice daily]. 20.1-40kg: 20mg/kg/day (twice daily)—500mg/day [250mg twice daily]; 40mg/kg/day (twice daily)—1,000mg/day [500mg twice daily]; 60mg/kg/day (twice daily)—1,500mg/day [750mg twice daily]. 40.1-50kg(2): 20mg/kg/day (twice daily)—1,000mg/day [500mg twice daily]; 40mg/kg/day (twice daily)—2,000mg/day [1,000mg twice daily]; 60mg/kg/day (twice daily)—3,000mg/day [1,500mg 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. 2. Myoclonic seizures in pediatric patients (12 years and older): This drug is initiated at 500mg twice daily. The dose is increased by 1,000mg/day every 2 weeks up to the recommended daily dose of 3,000mg. Efficacy has not been studied at doses below 3,000mg/day. 3. Primary generalized tonic-clonic seizures (12-17 years), adolescents weighing 50kg or more: This drug is initiated at 1,000mg/day [500mg twice daily]. The dose is increased by 1,000mg/day [500mg twice daily] every 2 weeks up to the recommended daily dose of 3,000mg [1,500mg twice daily]. Efficacy has not been adequately studied at doses below 3,000mg/day. Adolescents 12-17 years weighing less than 50kg (primary generalized tonic-clonic seizures): This drug is initiated at 20mg/kg/day [10mg/kg twice daily]. The dose is increased by 20mg/kg/day [10mg/kg twice daily] every 2 weeks up to the recommended daily dose of 60mg/kg [30mg/kg twice daily]. Efficacy has not been adequately studied at doses below 60mg/kg/day. Pediatric patients and adolescents weighing less than 50kg with renal impairment: Normal, ≥ 80: 10-30mg/kg(0.10-0.30 ml/kg) twice daily; mild, 50-79: 10-20mg/kg(0.10-0.20 ml/kg) twice daily; moderate, 30-49: 5-15mg/kg (0.05-0.15ml/kg) twice daily; severe, < 30: 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) After dialysis, an additional dose of 5-10 mg/kg(0.05-0.10ml/kg) is recommended. Dose adjustment formula for patients with renal impairment: ks= 0.45 (infants under 1 year); ks= 0.55 (children and female adolescents under 13 years); ks= 0.7 (male adolescents). 6. Children: The oral formulation is not recommended for infants under 1 month of age due to insufficient safety and efficacy data. Tablet administration is not applicable to children 4 years or younger; 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, as its safety and efficacy have not been established.

This medication is an antiepileptic drug and may increase the risk of suicidal thoughts or behaviors, so it is essential to consult a healthcare professional if mood or behavior changes occur during treatment. It may affect the central nervous system, potentially leading to sedation, fatigue, coordination difficulties, and behavioral abnormalities, especially in the first four weeks of treatment. Abruptly discontinuing the medication can worsen seizures, so the dosage should be gradually reduced under a doctor's guidance. Patients with an allergy to this medication or its components should not take it, and dosage adjustment may be necessary for patients with impaired renal function. Routine blood tests to monitor changes in white blood cell or platelet counts are important, and immediate medical attention is required for severe fatigue, fever, or symptoms of infection. The medication may cause psychiatric symptoms such as aggression, anxiety, depression, and irritability; thus, any abnormal behaviors should be discussed with a healthcare provider. During the initial administration or dose increase, seizures may be aggravated, so attention to changes in seizure symptoms is necessary. Patients with heart conditions or prolonged QT intervals should use caution when taking this medication. Women who are pregnant or planning to become pregnant should discuss the use of this medication with a healthcare provider, as abrupt discontinuation may pose risks to the fetus and mother. Breastfeeding cases should be discussed with a healthcare provider since this medication may be excreted in breast milk and affect the infant. Safety has not been established for children, particularly infants under one month old, and children under four years should be administered in liquid form rather than tablets. Elderly patients may have an increased risk of side effects due to decreased renal function, requiring careful dosage adjustment and monitoring. Caution should be exercised when driving or operating machinery, as drowsiness or decreased concentration may occur, particularly during the initial treatment phase or dose increase. In cases of overdose, symptoms such as drowsiness, agitation, aggression, reduced consciousness, or respiratory depression can occur, necessitating immediate medical treatment. This medication has relatively few drug interactions, but caution is warranted when used in conjunction with methotrexate, as it may alter blood concentrations. In the event of adverse reactions, notify healthcare professionals immediately, and the prescribed dosages and methods of administration should be strictly followed.

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

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius at room temperature. This can help preserve the medication's efficacy over time.

Appearance

Yellow oval film-coated tablet

Package unit

30 tablets/bottle, 120 tablets/bottle