Levicure Tablet 250 mg (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 - 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. Adjunctive therapy - Primary generalized tonic-clonic seizures, 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. Patients with renal impairment - Adults: Normal (≥ 80): 500-1,500mg per dose, twice daily (12-hour intervals) Patients with renal impairment - Adults: Mild (50-79): 500-1,000mg per dose, twice daily (12-hour intervals) Patients with renal impairment - Adults: Moderate (30-49): 250-750mg per dose, twice daily (12-hour intervals) Patients with renal impairment - Adults: Severe (< 30): 250-500mg per dose, twice daily (12-hour intervals) Patients with renal impairment - Adults: 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. 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%. Elderly patients (65 years and older): Dose adjustment is recommended in elderly patients with impaired renal function.

Child dose

Adjunctive therapy - partial-onset seizures, children aged 4 to 11 years and adolescents aged 12 to 17 years weighing less than 50 kg: The initial dose is 10mg/kg per dose, 2 times daily. Depending on clinical response and tolerability, the dose may be increased to 60mg/kg/day [30mg/kg per dose, 2 times daily]; dose adjustments should not exceed an increase or decrease of 20mg/kg/day [10mg/kg per dose, 2 times daily] every 2 weeks. Use the lowest effective dose. The dose for children weighing 50 kg or more is the same as the adult dose. 15-20kg(1): 20mg/kg/day (2 times daily) 300mg-400mg/day [150-200mg per dose, 2 times daily]; 40mg/kg/day (2 times daily) 600mg-800mg/day [300-400mg per dose, 2 times daily]; 60mg/kg/day (2 times daily) 900mg-1,200mg/day [450-600mg per dose, 2 times daily] 20.1-40kg: 20mg/kg/day (2 times daily) 500mg/day [250mg per dose, 2 times daily]; 40mg/kg/day (2 times daily) 1,000mg/day [500mg per dose, 2 times daily]; 60mg/kg/day (2 times daily) 1,500mg/day [750mg per dose, 2 times daily] 40.1-50kg(2): 20mg/kg/day (2 times daily) 1,000mg/day [500mg per dose, 2 times daily]; 40mg/kg/day (2 times daily) 2,000mg/day [1,000mg per dose, 2 times daily]; 60mg/kg/day (2 times daily) 3,000mg/day [1,500mg per dose, 2 times 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 and older): Treatment with this drug is initiated at 500mg per dose, 2 times daily. The dose is increased by 1,000mg/day every 2 weeks up to the recommended daily dose of 3,000mg. Efficacy at doses below 3,000mg/day has not been studied. Adjunctive therapy - primary generalized tonic-clonic seizures, adolescents weighing 50kg or more (12-17 years): Treatment with this drug is initiated at 1,000mg/day [500mg per dose, 2 times daily]. The dose is increased by 1,000mg/day [500mg per dose, 2 times daily] every 2 weeks up to the recommended daily dose of 3,000mg [1,500mg per dose, 2 times daily]. Efficacy at doses below 3,000mg/day has not been adequately studied. Adjunctive therapy - primary generalized tonic-clonic seizures, adolescents aged 12-17 years weighing less than 50kg: Treatment with this drug is initiated at 20mg/kg/day [10mg/kg per dose, 2 times daily]. The dose is increased by 20mg/kg/day [10mg/kg per dose, 2 times daily] every 2 weeks up to the recommended daily dose of 60mg/kg [30mg/kg per dose, 2 times 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 (≥ 80): 10-30mg/kg(0.10-0.30 ml/kg) 2 times daily Pediatric patients and adolescents weighing less than 50kg with renal impairment - Mild (50-79): 10-20mg/kg(0.10-0.20 ml/kg) 2 times daily Pediatric patients and adolescents weighing less than 50kg with renal impairment - Moderate (30-49): 5-15mg/kg (0.05-0.15ml/kg) 2 times daily Pediatric patients and adolescents weighing less than 50kg with renal impairment - Severe (< 30): 5-10 mg/kg (0.05-0.10ml/kg) 2 times daily Pediatric patients and adolescents weighing less than 50kg with renal impairment - 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) ks= 0.55 (female children and adolescents under 13 years) ks= 0.7 (male adolescents) The oral formulation is not recommended for infants under 1 month of age due to insufficient safety and efficacy data. Tablets are not applicable for children aged 4 years or younger, and the oral solution should be administered to infants aged 1 month or older. Injection is not recommended for use in children under 16 years of age 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 patients and caregivers should carefully monitor for these symptoms. During the initial period of treatment, central nervous system side effects such as drowsiness, fatigue, coordination impairments, and behavioral changes may occur, so caution is needed. When discontinuing the medication, the dose should be gradually reduced to prevent worsening seizures, as sudden withdrawal can be dangerous. Patients with hypersensitivity to this medication or certain genetic issues such as lactose intolerance should avoid taking it. If suicidal thoughts or depressive symptoms occur, one must consult a healthcare professional immediately, and dosage adjustments may be required for patients with impaired kidney function. Blood dyscrasias like reduction in blood cell count can occur, so examination is necessary if fevers or infection symptoms arise. Psychiatric symptoms can include irritability, aggression, anxiety, depression, and these symptoms may require medication adjustments if severe. Seizures can worsen, so if symptoms change, patients should consult a physician immediately. Patients with heart disease or electrolyte imbalances should be cautious regarding electrocardiogram abnormalities. During pregnancy, the use of this medication may affect the fetus, so healthcare professionals should be consulted, and during breastfeeding, this medication may be passed to the baby through breast milk, so careful consideration of breastfeeding is necessary. Dosage adjustments and caution are needed for children and the elderly, especially since safety has not been established for infants under 1 month. Symptoms like drowsiness may occur during driving or operating machinery, so caution is necessary. In case of overdose, contact a medical institution immediately for appropriate treatment, and there is no antidote for this medication, so symptomatic treatment will be provided according to symptoms. This medication has low drug interaction when used with other antiepileptics or oral contraceptives, but caution is needed regarding blood concentration changes when used with methotrexate. Finally, this medication should be kept out of the reach of children, and changing the storage container should be avoided as it can lead to accidents.

• suicidal thoughts
• suicidal behavior
• depression
• abnormal changes in mood and behavior
• drowsiness
• fatigue
• akathisia
• abnormal behavior
• asthenia
• ataxia

This medication should be stored in a tightly closed container to prevent air and moisture from entering, and it is recommended to keep it at room temperature between 1 and 30 degrees Celsius.

Appearance

White oval film-coated tablets

Package unit

30 tablets/bottle, 120 tablets/bottle