Keppra (Levetiracetam)

Adult dose

Film-coated tablets and oral solution are administered orally and may be taken with or without food. Take 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, the switch may be made directly without dose titration; the total daily dose and frequency of administration should remain the same. Monotherapy for partial-onset seizures (4 years and older): Adults (18 years and older) and adolescents weighing 50kg or more (12~17 years) This medication is started at 500mg twice daily. However, based on the physician's assessment of potential adverse reactions in relation to seizure reduction, the initial dose may be reduced to 250mg twice daily and increased to 500mg twice daily after 2 weeks. Depending on clinical response and tolerability, the dose may be increased or decreased every 2 to 4 weeks by 500mg per day [250mg per dose, twice daily] or 1000mg per day [500mg per dose, twice daily]. The maximum recommended dose is 3000mg per day [1500mg per dose, twice daily]. Adjunctive therapy for partial-onset seizures (1 month and older): Adults (18 years and older) and adolescents weighing 50kg or more (12~17 years) This medication is started at 500mg twice daily. However, based on the physician's assessment of potential adverse reactions in relation to seizure reduction, the initial dose may be reduced to 250mg twice daily and increased to 500mg twice daily after 2 weeks. Depending on clinical response and tolerability, the dose may be increased or decreased every 2 to 4 weeks by 500mg per day [250mg per dose, twice daily] or 1000mg per day [500mg per dose, twice daily]. The maximum recommended dose is 3000mg per day [1500mg per dose, twice daily]. Adjunctive therapy for myoclonic seizures in pediatric patients (12 years and older) This medication is started at 500mg twice daily. However, based on the physician's assessment of potential adverse reactions in relation to seizure reduction, the initial dose may be reduced to 250mg twice daily and increased to 500mg twice daily after 2 weeks. Depending on clinical response and tolerability, the dose may be increased or decreased every 2 weeks by 500mg per day [250mg per dose, twice daily] or 1000mg per day [500mg per dose, twice daily]. The maximum recommended dose is 3000mg per day [1500mg per dose, twice daily]. Efficacy at doses below 3000mg per day has not been studied. Adjunctive therapy for primary generalized tonic-clonic seizures (12 years and older): Adults (18 years and older) and adolescents weighing 50kg or more (12-17 years) This medication is started at 1,000mg per day [500mg per dose, twice daily]. However, based on the physician's assessment of potential adverse reactions in relation to seizure reduction, the initial dose may be reduced to 250mg twice daily and increased to 500mg twice daily after 2 weeks. Depending on clinical response and tolerability, the dose may be increased or decreased every 2 weeks by 500mg per day [250mg per dose, twice daily] or 1000mg per day [500mg per dose, twice daily]. The maximum recommended dose is 3000mg per day [1500mg per dose, twice daily]. Efficacy at doses below 3000mg 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. To use the table, the patient's creatinine clearance (CLCr,ml/min) is required. In adults, it can be calculated from the serum creatinine (mg/dl) value using the following formula. CLcr (ml/min) = [140-age (years)] × body weight (kg) (× 0.85: for women) / 72 × serum creatinine (mg/dl) CLcr is then adjusted according to body surface area (BSA) as follows. CLcr (ml/min/1.73m2) = CLcr(ml/min) × 1.73 / body surface area (BSA, m2) Dose adjustment for adult patients with renal impairment Normal: ≥ 80, 500-1,500mg per dose, twice daily (12-hour intervals) Mild: 50-79, 500-1,000mg per dose, twice daily (12-hour intervals) Moderate: 30-49, 250-750mg per dose, twice daily (12-hour intervals) Severe: < 30, 250-500mg per dose, twice daily (12-hour intervals) 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, when 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

Monotherapy for partial-onset seizures (4 years and older): Children aged 4–11 years and adolescents aged 12–17 years weighing less than 50 kg 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 increases or decreases must not exceed 20mg/kg per day [10mg/kg per dose twice daily] every 2 weeks. Use the lowest effective dose. The dose for children weighing 50kg or more is the same as the adult dose. 15 kg(1): Initial dose 150mg per dose, 2 times daily; maximum dose 450mg per dose, 2 times daily 20 kg(1): Initial dose 200mg per dose, 2 times daily; maximum dose 600mg per dose, 2 times daily 25 kg: Initial dose 250mg per dose, 2 times daily; maximum dose 750mg per dose, 2 times daily 50 kg or more(2): Initial dose 500mg per dose, 2 times daily; maximum dose 1500mg 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 for partial-onset seizures (1 month and older): Infants aged 6–23 months, children aged 2–11 years, and adolescents aged 12–17 years weighing less than 50 kg 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 increases or decreases must not exceed 20mg/kg per day [10mg/kg per dose twice daily] every 2 weeks. Use the lowest effective dose. The dose for children weighing 50kg or more is the same as the adult dose. 6kg(1): Initial dose 60mg per dose, 2 times daily; maximum dose 180mg per dose, 2 times daily 10kg(1): Initial dose 100mg per dose, 2 times daily; maximum dose 300mg per dose, 2 times daily 15 kg(1): Initial dose 150mg per dose, 2 times daily; maximum dose 450mg per dose, 2 times daily 20 kg(1): Initial dose 200mg per dose, 2 times daily; maximum dose 600mg per dose, 2 times daily 25 kg: Initial dose 250mg per dose, 2 times daily; maximum dose 750mg per dose, 2 times daily 50 kg or more(2): Initial dose 500mg per dose, 2 times daily; maximum dose 1500mg 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. Infants aged 1–6 months The initial dose is 7mg/kg per dose twice daily. Depending on clinical response and tolerability, the dose may be increased up to 21mg/kg per dose twice daily. Dose increases or decreases must not exceed 7mg/kg per dose twice daily every 2 weeks. Use the lowest effective dose. Treatment in infants should be initiated with the 100mg/ml oral solution. 4kg: Initial dose 28mg (0.3ml) per dose, 2 times daily; maximum dose 84mg (0.85ml) per dose, 2 times daily 5kg: Initial dose 35mg (0.35ml) per dose, 2 times daily; maximum dose 105mg (1.05ml) per dose, 2 times daily 7kg: Initial dose 49mg (0.5ml) per dose, 2 times daily; maximum dose 147mg (1.5ml) per dose, 2 times daily Adjunctive therapy for myoclonic seizures in pediatric patients (12 years and older) 12 years and older: This medicine is initiated at 500mg per dose twice daily. However, based on the physician's assessment of potential adverse reactions relative to seizure reduction, the initial dose may be lowered to 250mg per dose twice daily and increased to 500mg per dose twice daily after 2 weeks. Depending on clinical response and tolerability, the dose may be increased or decreased every 2 weeks by 500mg per day [250mg per dose twice daily] or 1000mg per day [500mg per dose twice daily], up to the maximum recommended dose of 3000mg per day [1500mg per dose twice daily]. Efficacy has not been studied at doses below 3000mg per day. Adjunctive therapy for primary generalized tonic-clonic seizures (12 years and older): Adolescents aged 12–17 years weighing less than 50 kg This medicine is initiated at 20mg/kg per day [10mg/kg per dose twice daily]. The dose is increased 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 has not been adequately studied at doses below 60mg/kg per day. 15kg(1): Initial dose 150mg per dose, 2 times daily; maximum dose 450mg per dose, 2 times daily 20kg(1): Initial dose 200mg per dose, 2 times daily; maximum dose 600mg per dose, 2 times daily 25kg: Initial dose 250mg per dose, 2 times daily; maximum dose 750mg per dose, 2 times daily 50kg or more(2): Initial dose 500mg per dose, 2 times daily; maximum dose 1500mg 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. Patients with renal impairment: Use the following formula for infants, children, and adolescents. CLcr (ml/min/1.73m2) = height (cm) × ks / serum creatinine (mg/dl) ks= 0.45 (infants under 1 year) ; ks= 0.55 (children under 13 years and female adolescents) ; ks= 0.7 (male adolescents) Dose adjustment for infants, children, and adolescents weighing less than 50kg with renal impairment Infants aged 1-6 months / Infants aged 6-23 months, children, and adolescents weighing less than 50kg Normal ≥ 80: Infants aged 1-6 months 7-21mg/kg (0.07-0.21ml/kg) 2 times daily; Infants aged 6-23 months, children, and adolescents weighing less than 50kg 10-30mg/kg (0.10-0.30 ml/kg) 2 times daily Mild 50-79: Infants aged 1-6 months 7-14mg/kg (0.07-0.14ml/kg) 2 times daily; Infants aged 6-23 months, children, and adolescents weighing less than 50kg 10-20mg/kg (0.10-0.20 ml/kg) 2 times daily Moderate 30-49: Infants aged 1-6 months 3.5-10.5mg/kg (0.035-0.105ml/kg) 2 times daily; Infants aged 6-23 months, children, and adolescents weighing less than 50kg 5-15mg/kg (0.05-0.15ml/kg) 2 times daily Severe < 30: Infants aged 1-6 months 3.5-7mg/kg (0.035-0.07 ml/kg) 2 times daily; Infants aged 6-23 months, children, and adolescents weighing less than 50kg 5-10 mg/kg (0.05-0.10ml/kg) 2 times daily End-stage renal disease patients on dialysis(1): Infants aged 1-6 months 7-14mg/kg (0.07-0.14ml/kg) 1 time daily(1)(3); Infants aged 6-23 months, children, and adolescents weighing less than 50kg 10-20mg/kg (0.10-0.20 ml/kg) 1 time daily(2)(4) (1) On the first day of treatment, administration of a loading dose of 10.5 mg/kg (0.105 ml/kg) is recommended. (2) On the first day of treatment, administration of a loading dose of 15 mg/kg (0.15 ml/kg) is recommended. (3) After dialysis, administration of an additional dose of 3.5-7 mg/kg (0.035-0.07 ml/kg) is recommended. (4) After dialysis, administration of an additional dose of 5-10 mg/kg (0.05-0.10 ml/kg) is recommended. Pediatrics: The oral formulation is not recommended for infants under 1 month because of insufficient safety and efficacy data. Tablets are not applicable for children under 4 years of age, and the oral solution should be administered to infants 1 month and older. The injection is not recommended for children under 16 years of age because its safety and efficacy have not been established.

This drug is used for the treatment of epilepsy, and there may be the emergence of mental health issues such as suicidal thoughts or behaviors and depression during use, hence careful monitoring is necessary. Additionally, neurological and psychiatric side effects such as drowsiness, fatigue, coordination disorders, and behavioral changes may occur, especially during the first 4 weeks of treatment. Abrupt discontinuation of the medication can lead to more frequent seizures, so it must be tapered off gradually under the direction of a physician. Patients with allergies to any components of this drug or those with fructose intolerance should not take it, and caution is advised due to the presence of excipients that may cause allergic reactions. Patients with impaired kidney function may require dosage adjustment, and those with severely impaired liver function should have kidney function tests performed before administration. Blood cell counts may decrease, hence blood tests should be conducted if symptoms such as weakness, fever, or signs of infection occur. This drug may also cause psychiatric symptoms or behavior changes such as aggression and irritability, therefore close monitoring of the patient's moods and behavior is required. Moreover, seizures may worsen, so if symptoms deteriorate, prompt consultation with a physician is necessary. Patients with cardiac diseases or electrocardiographic abnormalities should be cautious of potential prolongation of the QT interval with this drug. Drowsiness or decreased concentration may occur during driving or operating machinery, hence caution or avoidance of such activities is recommended. Use of this medication during pregnancy can affect the fetus, so women who are pregnant or planning to become pregnant must consult with healthcare professionals, and breastfeeding should be reconsidered as the medication can pass through breast milk. Careful dosage adjustment and monitoring are also necessary when administering to children and the elderly. In cases of overdose, symptoms may include drowsiness, aggression, and decreased consciousness, and as there is no specific antidote, symptomatic treatment such as inducing vomiting, gastric lavage, or blood dialysis may be required. This drug has minimal interactions with other antiepileptic drugs or oral contraceptives and warfarin, but caution should be taken as co-administration with methotrexate may increase blood concentration. During treatment, it is important to strictly adhere to the prescribed dosage and administration method and immediately inform healthcare professionals of any unusual symptoms.

• Suicidal ideation
• suicidal behavior
• depression
• abnormal changes in mood and behavior
• drowsiness
• fatigue
• coordination disorders
• behavioral abnormalities
• lethargy
• psychotic symptoms

This medication should be stored in a tightly sealed container that can block light, and the appropriate storage temperature is at room temperature between 1 to 30 degrees Celsius. After opening, it is safe to consume all within 7 months.

Appearance

A colorless to light yellow-brown transparent solution in a brown glass vial

Package unit

150 milliliters