Levetiracetam 250 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 - 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): 500-1,500mg per dose, twice daily (12-hour interval) Adult patients with renal impairment - Mild (50-79 mL/min/1.73m2): 500-1,000mg per dose, twice daily (12-hour interval) Adult patients with renal impairment - Moderate (30-49 mL/min/1.73m2): 250-750mg per dose, twice daily (12-hour interval) Adult patients with renal impairment - Severe (< 30 mL/min/1.73m2): 250-500mg per dose, twice daily (12-hour interval) Adult patients with renal impairment - End-stage renal disease patients on 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. 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 to 11 years and adolescents aged 12 to 17 years weighing less than 50 kg: The initial dose is 10 mg/kg per dose twice daily. Depending on clinical response and tolerability, the dose may be increased to 60 mg/kg/day [30 mg/kg per dose twice daily]. Dose adjustments should not exceed an increase or decrease of 20 mg/kg/day [10 mg/kg per dose twice daily] every 2 weeks. Use the lowest effective dose. The dosage for children weighing 50 kg or more is the same as the adult dosage. Partial-onset seizures—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] Partial-onset seizures—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] Partial-onset seizures—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 start 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): Start this medicine at 500mg per dose twice daily. Increase the dose by 1,000mg/day every 2 weeks 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 (12 years and older), adolescents aged 12-17 years weighing less than 50kg: Start this medicine at 20mg/kg/day [10mg/kg per dose twice daily]. Increase the dose by 20mg/kg/day [10mg/kg per dose twice daily] every 2 weeks to the recommended daily dose of 60mg/kg [30mg/kg per dose twice 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) twice daily Pediatric patients and adolescents weighing less than 50kg with renal impairment—Mild (50-79 ml/min/1.73m2): 10-20mg/kg(0.10-0.20 ml/kg) twice daily Pediatric patients and adolescents weighing less than 50kg with renal impairment—Moderate (30-49 ml/min/1.73m2): 5-15mg/kg (0.05-0.15ml/kg) twice daily Pediatric patients and adolescents weighing less than 50kg with renal impairment—Severe (< 30 ml/min/1.73m2): 5-10 mg/kg (0.05-0.10ml/kg) twice daily Pediatric patients and adolescents weighing less than 50kg with renal impairment—End-stage renal disease patients undergoing dialysis (creatinine clearance --): 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 (children and adolescent females under 13 years) ks= 0.7 (adolescent males) Oral formulations are not recommended for infants under 1 month of age due to insufficient safety and efficacy data. Tablet administration is not applicable for children under 4 years of age; infants aged 1 month or older should receive the oral solution. Injection is not recommended for children under 16 years of age because its safety and efficacy have not been established.

This medication may increase the risk of suicidal thoughts or behaviors, so you must consult a doctor immediately if symptoms of depression or mood changes occur while taking this medication. It can affect the central nervous system, leading to symptoms such as drowsiness, fatigue, coordination problems, and behavioral abnormalities, so caution is necessary. Sudden discontinuation of this medication can worsen seizures, so the dosage should be gradually reduced. You should not take this medication if you have an allergic reaction to the active ingredient or any other components. Patients with suicidal thoughts or depressive symptoms need special attention during treatment, and they should inform the doctor immediately if symptoms arise. Patients with reduced kidney function may need to have their dosage adjusted, so they should consult a healthcare professional. Adverse reactions associated with a decrease in blood cell count may occur, so if fever or signs of infection appear, blood tests should be done. Psychiatric symptoms, such as irritability, aggression, and mood changes, may occur, so if these symptoms appear, consult a healthcare professional. During the initial phase or when increasing the dosage of this medication, seizures may worsen. Therefore, monitor changes in symptoms closely. Patients with heart disease or those with a prolonged QT interval on an ECG should take caution when using this medication. Drowsiness or dizziness may occur when driving or operating machinery, so be careful. Women who are pregnant or planning to become pregnant should discuss the use of this medication with healthcare professionals, and during breastfeeding, the medication can be excreted in breast milk, potentially affecting the baby, so nursing decisions should be made carefully. The safety of this medication has not been established in infants under 1 month of age, and for children under 4 years old, administration in liquid form is recommended. In cases of overdose, symptoms such as drowsiness, anxiety, aggression, and decreased consciousness may occur, and immediate medical attention is necessary. This medication has a low potential for interactions with other drugs; however, caution is needed when used concurrently with certain medications, so inform healthcare professionals of any medications being taken. There is insufficient long-term research on the effects of this medication on children's growth, puberty, and learning abilities, so regular evaluations are necessary during prolonged use.

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

This medication may be sensitive to air or moisture, so it must be stored in a sealed container. Additionally, it is important to keep it at a temperature between 1 degree and 30 degrees Celsius to maintain its effectiveness.

Appearance

Blue oval film-coated tablet

Package unit

30 tablets/bottle, 120 tablets/bottle