Keppra 250 mg Tablet (Levetiracetam)

Adult dose

Film-coated tablets and oral solution are administered orally, may be taken with or without food, and should be taken with plenty of water. The daily dose is divided into 2 equal doses administered twice daily. 1. Monotherapy and adjunctive therapy for partial-onset seizures (adults 18 years and older and adolescents 12~17 years weighing 50kg or more) Start with 500mg twice daily. At the physician’s discretion, 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 or 1000mg daily, up to a maximum of 3000mg daily. 2. Adjunctive therapy for primary generalized tonic-clonic seizures (adults 18 years and older and adolescents weighing 50kg or more) Start with 1000mg as 500mg twice daily. Based on the physician’s assessment, the initial dose may be reduced to 250mg twice daily and may be increased to 500mg twice daily after 2 weeks. The maximum recommended dose is 3000mg daily. 3. Dose adjustment in patients with renal impairment The dose per administration and dosing regimen vary according to creatinine clearance. The usual regimen is twice daily, but patients with end-stage renal disease undergoing dialysis receive the medicine once daily. 4. Patients with hepatic impairment In patients with severe hepatic impairment, if creatinine clearance is less than 60mL/min/1.73m2, reduce the daily maintenance dose by 50%. 5. Older adults (65 years and older) Dose adjustment is recommended according to reduced renal function.

Child dose

1. Monotherapy and adjunctive therapy for partial-onset seizures (children 4 years and older and adolescents weighing less than 50kg) Start with an initial dose of 10mg/kg twice daily. Depending on clinical response and tolerability, the dose may be increased to a maximum of 60mg/kg daily. Increases or decreases of more than 20mg/kg daily every 2 weeks are not permitted. For children weighing 20kg or less, it is recommended to initiate treatment with the 100mg/ml oral solution. For children weighing 20~40kg, start with 500mg as 250mg twice daily; the dose may be increased by 500mg daily every 2 weeks, up to a maximum of 1500mg daily. For children weighing more than 40kg, start with 1000mg as 500mg twice daily; the dose may be increased by 1000mg daily every 2 weeks, up to a maximum of 3000mg daily. For children weighing 50kg or more, the adult dose applies. 2. Adjunctive therapy for myoclonic seizures in children (12 years and older) As in adults, start with 500mg twice daily. At the physician’s discretion, the initial dose may be reduced to 250mg twice daily. The dose may be increased or decreased by 500mg or 1000mg daily every 2 weeks, up to a maximum of 3000mg daily. 3. Adjunctive therapy for primary generalized tonic-clonic seizures (adolescents 12 years and older weighing less than 50kg) Start with 20mg/kg daily as 10mg/kg twice daily, and increase by 20mg/kg daily every 2 weeks, up to the maximum recommended dose of 60mg/kg daily. 4. Children and adolescents weighing less than 50kg with renal impairment The dose per administration varies according to creatinine clearance. The usual regimen is twice daily, but patients with end-stage renal disease undergoing dialysis receive the medicine once daily. 5. No separate information is provided for patients with hepatic impairment or older adults. 6. Not recommended for infants under 1 month of age. For children 4 years and younger, use the oral solution instead of tablets. The injection is not recommended for children under 16 years of age.

This medication may increase the risk of suicidal thoughts or behaviors, so changes in mood or behavior should be closely monitored during treatment. It may affect the central nervous system and cause symptoms such as drowsiness, fatigue, coordination problems, and behavioral abnormalities, particularly in the first 4 weeks. Abrupt discontinuation of this medication may lead to increased seizure frequency, so the dosage should be gradually reduced. This medication should not be used if there is a known allergy to its components or genetic issues such as lactose intolerance. Patients with suicidal thoughts or depressive symptoms should inform their healthcare provider immediately, and those with renal impairment may require dosage adjustments. Blood cell counts may decrease, so if symptoms such as weakness or fever occur, medical examination is necessary. Psychiatric symptoms or aggression and behavioral changes may occur, so consultation with a physician should be sought if these symptoms appear. Attention should be paid to any changes in seizure symptoms as seizures may worsen. Patients with heart diseases or those with prolonged QT intervals may require an ECG. This medication contains specific dyes, so caution is advised in cases of hypersensitivity. Careful use is required during pregnancy due to potential effects on the fetus, and it is not recommended during breastfeeding as it can affect the infant through breast milk. Children and the elderly may require dosage adjustments based on kidney function. Drowsiness or decreased concentration may occur while driving or operating machinery, so caution is advised. In case of overdose, immediate medical attention is necessary, as there is no specific antidote. When storing this medication, keep it out of reach of children, and do not transfer it to another container.

• suicidal impulses
• suicidal behavior
• depression
• abnormal changes in mood and behavior
• drowsiness
• fatigue
• coordination disturbances
• behavioral abnormalities
• weakness
• ataxia

This medication should be stored in a tightly sealed container to prevent air or moisture intrusion, and it is important to maintain a storage temperature between 1 degree and 30 degrees Celsius. Proper storage helps to preserve the medication's effectiveness.

Appearance

Blue oval film-coated tablets

Package unit

60 tablets (10 tablets/PTP × 6), 30 tablets/bottle, 100 tablets/bottle