Keppra 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 and administered twice daily. Levetiracetam treatment may be initiated by intravenous or oral administration. When switching from oral to intravenous administration or vice versa, treatment may be switched directly without dose titration, and the total daily dose and frequency of administration should remain the same. Monotherapy: Adults and adolescents 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/day [250mg per dose, twice daily] every 2 weeks. The maximum dose is 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 by 1000mg/day [500mg per dose, twice daily] every 2 to 4 weeks. The maximum recommended dose is 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 at doses below 3,000mg/day has not been adequately studied. Patients with renal impairment: Since levetiracetam clearance is related to renal function, the dose should be individualized according to the patient's renal function. Dose adjustment in adult patients with renal impairment — Normal, creatinine clearance ≧ 80 (ml/min/1.73m2): 500-1,500mg per dose, twice daily (12-hour intervals) Dose adjustment in adult patients with renal impairment — Mild, creatinine clearance 50-79 (ml/min/1.73m2): 500-1,000mg per dose, twice daily (12-hour intervals) Dose adjustment in adult patients with renal impairment — Moderate, creatinine clearance 30-49 (ml/min/1.73m2): 250-750mg per dose, twice daily (12-hour intervals) Dose adjustment in adult patients with renal impairment — Severe, creatinine clearance < 30 (ml/min/1.73m2): 250-500mg per dose, twice daily (12-hour intervals) Dose adjustment in 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 needed 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 reduced renal function.

Child dose

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 twice daily. Depending on clinical response and tolerability, the dose may be increased up to 60mg/kg/day [30mg/kg per dose, twice daily]. Dose adjustments should not exceed increases or decreases of 20mg/kg/day [10mg/kg per dose, twice daily] every 2 weeks. Use the lowest effective dose. Recommended doses for partial-onset seizures — Body 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] Recommended doses for partial-onset seizures — Body 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] Recommended doses for partial-onset seizures — Body 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) 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. Myoclonic seizures in pediatric patients (12 years and older): This medicine is initiated at 500mg per dose twice daily. The dose is increased 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. Primary generalized tonic-clonic seizures: Adolescents (12-17 years) weighing 50kg or more — The same as the adult dose. Primary generalized tonic-clonic seizures: Adolescents aged 12-17 years weighing less than 50kg — This medicine is initiated at 20mg/kg/day [10mg/kg per dose, twice daily]. The dose is increased 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. Dose adjustment for pediatric patients and adolescents weighing less than 50kg with renal impairment — Normal, creatinine clearance ≧ 80 (ml/min/1.73m2): dose and administration per dose 10-30mg/kg(0.10-0.30 ml/kg) twice daily Dose adjustment for pediatric patients and adolescents weighing less than 50kg with renal impairment — Mild, creatinine clearance 50-79 (ml/min/1.73m2): dose and administration per dose 10-20mg/kg(0.10-0.20 ml/kg) twice daily Dose adjustment for pediatric patients and adolescents weighing less than 50kg with renal impairment — Moderate, creatinine clearance 30-49 (ml/min/1.73m2): dose and administration per dose 5-15mg/kg (0.05-0.15ml/kg) twice daily Dose adjustment for pediatric patients and adolescents weighing less than 50kg with renal impairment — Severe, creatinine clearance < 30 (ml/min/1.73m2): dose and administration per dose 5-10 mg/kg (0.05-0.10ml/kg) twice daily Dose adjustment for pediatric patients and adolescents weighing less than 50kg with renal impairment — End-stage renal disease patients on dialysis, creatinine clearance --: dose and administration per dose 10-20mg/kg(0.10-0.20 ml/kg) once daily(1)(2) (1) On the first day of treatment, administration of a loading dose of 15 mg/kg(0.15ml/kg) is recommended. (2) After dialysis, administration of an additional dose of 5-10 mg/kg(0.05-0.10ml/kg) is recommended. Pediatric renal function adjustment factors: ks= 0.45 (infants under 1 year) ; ks= 0.55 (children and adolescent females under 13 years) ks= 0.7 (adolescent males) The oral formulation is not recommended for infants under 1 month due to insufficient safety and efficacy data. Tablet administration is not applicable to children under 4 years, and the oral solution should be administered to infants aged 1 month or older. Administration of the injection is not recommended for children under 16 years because its safety and efficacy have not been established.

This medication may increase the risk of suicidal thoughts or behaviors, and mental health issues such as depression, so patients should consult a doctor immediately if mood changes or unusual behavior occurs during treatment. This medication may cause central nervous system side effects such as drowsiness, fatigue, coordination disturbances, and behavioral changes, especially during the first 4 weeks. Abrupt discontinuation may worsen seizures, so the dosage should be gradually reduced under a doctor's supervision. This medication should not be taken if there is an allergic reaction to it or its ingredients. Patients with a history of depression or suicidal thoughts, or with impaired kidney function, require special caution when using this medication, and blood tests can be conducted to check for side effects. This medication can cause psychiatric symptoms such as aggression, irritability, and anxiety, so any unusual behavior should be discussed with a doctor. Seizures may worsen during initial dosing or dosage increases, so if symptoms deteriorate, immediate consultation with healthcare professionals is necessary. Patients with heart conditions or electrolyte imbalances should be closely monitored for their cardiac status, potentially including electrocardiogram testing. Women who are pregnant or planning to become pregnant should consult a doctor before deciding to use this medication, and breastfeeding mothers may need to discontinue breastfeeding or reconsider medication use due to potential transfer of the drug through breast milk. Dosing adjustments may be necessary for children and elderly patients based on kidney function, especially since the safety of this medication has not been established in infants under 1 month of age. Caution is advised when driving or operating machinery due to potential drowsiness or decreased concentration. In case of overdose, the medication should be removed through vomiting or gastric lavage, and as there are no specific antidotes, symptomatic treatment is required. This medication has limited drug interactions when taken with other antiepileptic drugs or oral contraceptives, but close monitoring of blood levels is necessary when used concomitantly with methotrexate. If symptoms of hypersensitivity such as fever, rash, or swollen lymph nodes occur during use, the medication should be discontinued immediately and healthcare professionals notified.

• suicidal thoughts
• suicidal behavior
• depression
• drowsiness
• fatigue
• coordination disorders
• abnormal behavior
• asthenia
• behavioral disorders
• aggression

This medication should be stored in a tightly closed container to protect it from air and moisture. It is recommended to store the medication at room temperature between 1 degree and 30 degrees Celsius. Avoid storing in extremely hot or cold places.

Appearance

Blue oval film-coated tablet

Package unit

60 tablets/box [10 tablets/PTP×6]