Keppra 250 mg (Levetiracetam)

Adult dose

The film-coated tablets and oral solution are administered orally and may be taken with or without food, 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 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 and adjunctive therapy for partial-onset seizures: Adults (18 years and older) Treatment with this medicine is initiated at 500mg twice daily. However, based on the physician's assessment of potential adverse reactions versus 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/day [250mg per dose, twice daily] or 1000mg/day [500mg per dose, twice daily], and the maximum recommended dose is 3000mg/day [1500mg per dose, twice daily]. Adjunctive therapy for myoclonic seizures in pediatric patients (12 years and older): Adult dosage and administration Treatment with this medicine is initiated at 500mg twice daily. However, based on the physician's assessment of potential adverse reactions versus 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/day [250mg per dose, twice daily] or 1000mg/day [500mg per dose, twice daily], and the maximum recommended dose is 3000mg/day [1500mg per dose, twice daily]. Efficacy at doses below 3,000mg/day has not been studied. Adjunctive therapy for primary generalized tonic-clonic seizures (12 years and older): Adults (18 years and older) Treatment with this medicine is initiated at 1,000mg/day [500mg per dose, twice daily]. However, based on the physician's assessment of potential adverse reactions versus 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/day [250mg per dose, twice daily] or 1000mg/day [500mg per dose, twice daily], and the maximum recommended dose is 3000mg/day [1500mg 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, individualize the dose according to the patient's renal function. Refer to the table below for dose adjustment in adults. Dosage adjustment in adult patients with renal impairment Normal, ≧ 80 ml/min/1.73m2, 500-1,500mg, twice daily (12-hour intervals) Mild, 50-79 ml/min/1.73m2, 500-1,000mg, twice daily (12-hour intervals) Moderate, 30-49 ml/min/1.73m2, 250-750mg, twice daily (12-hour intervals) Severe, < 30 ml/min/1.73m2, 250-500mg, twice daily (12-hour intervals) End-stage renal disease patients on dialysis(1), -, 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 impairment. Therefore, when creatinine clearance is less than 60mL/min/1.73m2, it is recommended that the daily maintenance dose be reduced by 50%. 7. Older adults (65 years and older) Dose adjustment is recommended in elderly patients with reduced renal function.

Child dose

Monotherapy and adjunctive therapy for partial-onset seizures (4 years and older): Adolescents weighing 50 kg or more (12~17 years) This medication is started at 500mg 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 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］, and the maximum recommended dose is 3000mg per day[1500mg per dose, twice daily]. Monotherapy and adjunctive therapy for partial-onset seizures: Children aged 4 years to 11 years and adolescents aged 12~17 years weighing less than 50 kg The initial dose is 10mg/kg 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], and dose changes should not exceed increases or decreases of 20mg/kg per day[10mg/kg per dose, twice daily] every 2 weeks. Use the lowest effective dose. The maximum recommended dose is 3000mg per day. For children weighing 20kg or less, it is recommended to start treatment with the 100mg/ml oral solution. For children weighing 20~40kg, treatment is started at 500mg per day[250mg per dose, twice daily] and may be increased by 500mg per day every 2 weeks, up to a maximum of 1500mg per day[750mg per dose, twice daily]. For children weighing more than 40kg, treatment is started at 1000mg per day[500mg per dose, twice daily] and may be increased by 1000mg per day every 2 weeks, up to a maximum of 3000mg per day[1500mg per dose, twice daily]. The dose for children weighing 50kg or more is the same as the adult dose. 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 relative to seizure reduction, the initial dose may be lowered 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］, and the maximum recommended dose is 3000mg per day[1500mg per dose, twice daily]. Efficacy at doses below 3,000mg per day has not been studied. Adjunctive therapy for primary generalized tonic-clonic seizures (12 years and older): 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 relative to seizure reduction, the initial dose may be lowered 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］, and the maximum recommended dose is 3000mg per day[1500mg per dose, twice daily]. Efficacy at doses below 3,000mg per day has not been adequately studied. Adjunctive therapy for primary generalized tonic-clonic seizures: Adolescents aged 12-17 years weighing less than 50kg This medication is started 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 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. Dose adjustment in pediatric patients with renal impairment and adolescents weighing less than 50kg Normal, ≧ 80 ml/min/1.73m2, 10-30mg/kg(0.10-0.30 ml/kg) twice daily Mild, 50-79 ml/min/1.73m2, 10-20mg/kg(0.10-0.20 ml/kg) twice daily Moderate, 30-49 ml/min/1.73m2, 5-15mg/kg (0.05-0.15ml/kg) twice daily Severe, < 30 ml/min/1.73m2, 5-10 mg/kg (0.05-0.10ml/kg) twice daily End-stage renal disease patients on dialysis, --, 10-20mg/kg(0.10-0.20 ml/kg) once daily(1)(2) (1) On the first day of administration, 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. 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 younger than 1 month due to insufficient safety and efficacy data. Tablet administration is not applicable to children 4 years or younger; the oral solution should be administered to infants 1 month and older. The injection is not recommended for children under 16 years because its safety and efficacy have not been established.

This drug is used in the treatment of epilepsy, and there may be an increased risk of suicidal thoughts or behavior while taking it. Patients and caregivers should carefully monitor for mood changes or unusual behavior. Neuropsychiatric side effects, such as drowsiness, fatigue, motor coordination impairment, and behavioral abnormalities, may frequently occur at the beginning of treatment. Abrupt discontinuation of the drug may worsen seizures, so the dosage should be gradually reduced according to the physician's instructions. Patients with an allergy to this medication or who have had hypersensitivity reactions to its components should not use it. If suicidal thoughts or depressive symptoms occur, medical personnel should be notified immediately, and dosage adjustment may be necessary for patients with impaired kidney function. There may be side effects involving decreased blood cell counts, so if symptoms of fatigue, fever, or infection develop, a blood test should be performed. Psychotic symptoms or aggressive behavior may occur, so consultation with a physician is advised if unusual behavior is observed. If seizures worsen, immediate consultation with medical personnel is necessary. Patients with heart disease or abnormal electrocardiogram readings should be cautious when taking this medication. Women who are pregnant or planning to become pregnant should consult a physician before taking this medication, and if breastfeeding, should consider whether to discontinue nursing as the drug may pass into breast milk. Particular caution is required when administering this medication to children or the elderly; safety has not been established in infants under one month of age. Patients should be cautious while driving or operating machinery as drowsiness or decreased concentration may occur. In cases of overdose, the drug can be removed through vomiting or gastric lavage, and blood dialysis may be performed if necessary. This medication has a low potential for interactions with other drugs, but caution should be taken when used with methotrexate due to the possibility of increased blood concentration and related side effects. If unusual symptoms or side effects appear during treatment, consult medical personnel immediately, and the drug should be stored out of reach of children.

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

This medication should be kept in a tightly closed container to protect it from air and moisture, and it is safest to store it at room temperature between 1 and 30 degrees Celsius.

Appearance

Blue oval film-coated tablets

Package unit

60 tablets (10 tablets * 6 PTP)