Levetiracetam 1000 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, 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, 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, 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) Adult patients with renal impairment: Mild, creatinine clearance 50-79 mL/min/1.73m2, dose per administration 500-1,000mg, twice daily (12-hour interval) Adult patients with renal impairment: Moderate, creatinine clearance 30-49 mL/min/1.73m2, dose per administration 250-750mg, twice daily (12-hour interval) Adult patients with renal impairment: Severe, creatinine clearance < 30 mL/min/1.73m2, dose per administration 250-500mg, twice daily (12-hour interval) Adult patients with renal impairment: 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. 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%. Older patients (65 years and older): Dose adjustment is recommended in older patients with impaired renal function.

Child dose

Adjunctive therapy, partial-onset seizures: Children aged 4-11 years and adolescents aged 12-17 years weighing less than 50kg: 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 increases or decreases of 20mg/kg/day [10mg/kg per dose, 2 times daily] every 2 weeks. Use the lowest effective dose. The dose for children weighing 50kg or more is the same as the adult dose. Partial-onset seizures, body weight 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] Partial-onset seizures, body weight 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] Partial-onset seizures, body weight 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, primary generalized tonic-clonic seizures (12 years and older): Adolescents aged 12-17 years weighing less than 50kg: Initiate treatment with this medicine at 20mg/kg/day [10mg/kg per dose, 2 times daily]. The dose should be 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, creatinine clearance ≥ 80 (ml/min/1.73m2), 10-30mg/kg(0.10-0.30 ml/kg) 2 times daily Pediatric patients and adolescents weighing less than 50kg with renal impairment: Mild, creatinine clearance 50-79 (ml/min/1.73m2), 10-20mg/kg(0.10-0.20 ml/kg) 2 times daily Pediatric patients and adolescents weighing less than 50kg with renal impairment: Moderate, creatinine clearance 30-49 (ml/min/1.73m2), 5-15mg/kg (0.05-0.15ml/kg) 2 times daily Pediatric patients and adolescents weighing less than 50kg with renal impairment: Severe, creatinine clearance < 30 (ml/min/1.73m2), 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, creatinine clearance --, 10-20mg/kg(0.10-0.20 ml/kg) once daily(1)(2) (1) On the first day of treatment, a loading dose of 15 mg/kg(0.15ml/kg) is recommended. (2) After dialysis, an additional dose of 5-10 mg/kg(0.05-0.10ml/kg) is recommended. Renal function calculation formula: ks= 0.45 (infants younger than 1 year); ks= 0.55 (children and adolescent females younger than 13 years); ks= 0.7 (adolescent males) Children: The oral formulation is not recommended for infants younger than 1 month due to insufficient safety and efficacy data. Tablets are not suitable for children younger than 4 years, and the oral solution should be administered to infants aged 1 month or older. Use of the injection is not recommended in children younger than 16 years because its safety and efficacy have not been established.

This medication is used in the treatment of epilepsy and may increase the risk of suicidal thoughts or behaviors, as well as mental health issues such as depression during treatment. Therefore, patients and caregivers should immediately inform the physician of any changes in mood or behavior. Central nervous system side effects such as drowsiness, fatigue, coordination disorders, and behavioral abnormalities can commonly occur within the first 4 weeks. Special caution is required in children and patients aged 6 years and older as behavioral disorders may also arise. Discontinuing this medication abruptly may worsen seizures, so the dosage should be gradually reduced under the guidance of a physician. Patients allergic to this medication or its components should not take it. Patients with reduced kidney function or severe liver function may require dosage adjustments, and it is advisable to check for side effects through blood tests. This medication may cause psychiatric adverse reactions such as aggression, agitation, anxiety, and depression, so any unusual behavior should be discussed with a doctor. Additionally, if seizure symptoms worsen, immediate notification to medical personnel is necessary. Patients with heart disease or QT interval prolongation on an ECG should use this medication with caution. The effects of this medication on the fetus during pregnancy are not fully understood, so it should be used cautiously during pregnancy, and during breastfeeding, it may pass into breast milk, requiring reevaluation of medication use or cessation of breastfeeding. Safety has not been established in children, especially infants under 1 month; consultation with a specialist is recommended. Elderly patients may have decreased kidney function, so dosages should be determined carefully. This medication can cause symptoms such as drowsiness and fatigue, so caution is needed when driving or operating machinery. In case of overdose, removal of the drug through vomiting or gastric lavage may be necessary, and treatment might include hemodialysis. This medication has few interactions with other drugs, but caution is necessary when co-administering with specific medications; therefore, it is important to inform healthcare providers about any medications being taken. Finally, this medication should be stored in a safe place out of reach of children, and transferring it to other containers is discouraged.

• suicidal ideation
• suicidal behavior
• depression
• drowsiness
• fatigue
• akathisia
• behavioral abnormalities
• asthenia
• behavioral disorders
• aggression

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture, and it should be kept at room temperature between 1 to 30 degrees Celsius. By storing it this way, the efficacy of the medication can be maintained for a longer period.

Appearance

White oval film-coated tablets

Package unit

30 tablets/bottle, 120 tablets/bottle