Levetiracetam 500 mg (Levetiracetam)

Adult dose

Film-coated tablets and oral solution are administered orally and may be taken regardless of meals with a sufficient amount of water. The daily dose should be divided into 2 equal doses. Levetiracetam treatment may be initiated intravenously or orally. When changing 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 aged 16 years and older The initial dose is 250mg twice daily. After 2 weeks, increase the dose to 500mg twice daily. Depending on clinical response, the dose may be increased by 500mg per day [250mg per dose, twice daily] every 2 weeks; the maximum dose is 3000mg per day [1500mg per dose, twice daily]. Adjunctive therapy - 1. Partial-onset seizures: Adults (18 years and older) and adolescents weighing 50kg or more (12~17 years) Start this medicine at 500mg twice daily. Depending on clinical response and tolerability, the dose may be increased or decreased by 1000mg per day [500mg per dose, twice daily] every 2 to 4 weeks. The maximum recommended dose is 3000mg per day. Adjunctive therapy - 2. Myoclonic seizures in pediatric patients (12 years and older): Start this medicine at 500mg twice daily. Increase the dose by 1,000mg per day every 2 weeks up to the recommended daily dose of 3,000mg. Efficacy at doses below 3,000mg per day has not been studied. Adjunctive therapy - 3. Primary generalized tonic-clonic seizures (12 years and older): Adults (18 years and older) and adolescents weighing 50kg or more (12-17 years) Start this medicine at 1,000mg per day [500mg per dose, twice daily]. Increase the dose by 1,000mg per 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 at doses below 3,000mg per day has not been adequately studied. Patients with renal impairment: Since levetiracetam clearance is related to renal function, administer the dose individually according to the patient's renal function. Refer to the table below for dose adjustment in adults. Adult patients with renal impairment: Normal, creatinine clearance ≥ 80 mL/min/1.73m2, dose per administration 500-1,500mg, twice daily (12-hour interval) Mild, creatinine clearance 50-79 mL/min/1.73m2, dose per administration 500-1,000mg, twice daily (12-hour interval) Moderate, creatinine clearance 30-49 mL/min/1.73m2, dose per administration 250-750mg, twice daily (12-hour interval) Severe, creatinine clearance < 30 mL/min/1.73m2, dose per administration 250-500mg, twice daily (12-hour interval) End-stage renal disease patients on dialysis(1): Creatinine clearance -, dose per administration 500-1,000mg, 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 failure. Therefore, if creatinine clearance is below 60mL/min/1.73m2, it is advisable to reduce the daily maintenance dose by 50%. 7. Older patients (65 years and older): Dose adjustment is recommended in older patients with impaired renal function.

Child dose

Adjunctive therapy - 1. Partial-onset seizures: Children aged 4 years to 11 years and adolescents aged 12~17 years 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 per day [30mg/kg per dose, twice daily]. Dose changes must not exceed an increase or decrease of 20mg/kg per day [10mg/kg per dose, twice daily] every 2 weeks. Use the lowest effective dose. Doses for children weighing 50kg or more are the same as adult doses. 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) In 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 - 3. Primary generalized tonic-clonic seizures (12 years and older): Adolescents aged 12-17 years weighing less than 50kg Start this medicine at 20mg/kg per day [10mg/kg per dose, twice daily]. Increase the dose by 20mg/kg per 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 per 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), dose and administration 10-30mg/kg (0.10-0.30 ml/kg) twice daily Mild, creatinine clearance 50-79 (ml/min/1.73m2), dose and administration 10-20mg/kg (0.10-0.20 ml/kg) twice daily Moderate, creatinine clearance 30-49 (ml/min/1.73m2), dose and administration 5-15mg/kg (0.05-0.15ml/kg) twice daily Severe, creatinine clearance < 30 (ml/min/1.73m2), dose and administration 5-10 mg/kg (0.05-0.10ml/kg) twice daily End-stage renal disease patients on dialysis, creatinine clearance --, dose and administration 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. Use the following formulas for infants, children, and adolescents. ks= 0.45 (infants under 1 year) ; ks= 0.55 (children and female adolescents under 13 years) 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 applicable for children under 4 years of age; the oral solution should be administered to infants aged 1 month and older. The safety and efficacy of the injection have not been established in children under 16 years of age; therefore, its use is not recommended.

This medication is used to treat epilepsy, and there may be an increased risk of mental health issues, such as suicidal thoughts or behavior, during treatment, so careful observation is required. Drowsiness, fatigue, coordination difficulties, and behavioral changes are common in the first four weeks of treatment, so it is important to consult healthcare professionals if these symptoms occur. Stopping the medication abruptly may worsen seizures; therefore, the dosage should be gradually reduced, and it should not be discontinued arbitrarily. It should not be used in individuals who are hypersensitive to this drug or have allergies to its components. Patients with impaired kidney function or severely impaired liver function may need dosage adjustments, so they should consult healthcare professionals. This drug can trigger psychiatric symptoms such as behavioral change, aggression, depression, and anxiety, and immediate notification to healthcare professionals is required if these symptoms occur. Particularly, there can be cases where seizures worsen; thus, if the seizure symptoms intensify, please consult a physician immediately. Caution is also needed in patients with heart-related diseases or electrocardiogram abnormalities. During pregnancy, the effects on the fetus are not fully understood, so it should be used at the minimum dose only when necessary, and if breastfeeding, consideration must be given to the potential transfer of the medication via breast milk, possibly leading to cessation of breastfeeding or reevaluation of drug therapy. Careful dosage adjustments should be made when administering to children or the elderly, and safety has not been confirmed in infants under one month. There may be drowsiness or reduced concentration when driving or operating machinery, so caution is required. In case of overdose, symptoms such as drowsiness, agitation, aggression, and decreased consciousness may occur, necessitating immediate medical attention. This medication has relatively few interactions with other drugs; however, caution may be needed when taken with certain medications, so inform healthcare professionals of any medications being used. If any adverse reactions or uncomfortable symptoms occur during treatment, consult healthcare professionals immediately.

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

This medication should be stored in a tightly sealed container to prevent air and moisture from entering, and it is recommended to keep it at room temperature between 1°C and 30°C. Proper storage will help maintain the medication's effectiveness.

Appearance

Yellow oval film-coated tablet

Package unit

30 tablets/bottle, 120 tablets/bottle