Keppra 500 mg (Levetiracetam)

Adult dose

Film-coated tablets and oral solution are administered orally, with or without food, and should be taken with plenty of water. The total 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 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 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/day [250mg per dose, twice daily] or 1000mg/day [500mg per dose, twice daily], up to the maximum recommended dose of 3000mg/day [1500mg per dose, twice daily]. Adjunctive therapy for myoclonic seizures in pediatric patients (12 years and older): Treatment with this medicine is initiated 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/day [250mg per dose, twice daily] or 1000mg/day [500mg per dose, twice daily], up to the maximum recommended dose of 3000mg/day [1500mg per dose, twice daily]. Efficacy has not been studied at doses below 3,000mg/day. Adjunctive therapy for 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]. 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/day [250mg per dose, twice daily] or 1000mg/day [500mg per dose, twice daily], up to the maximum recommended dose of 3000mg/day [1500mg per dose, twice daily]. Efficacy has not been adequately studied at doses below 3,000mg/day. Patients with renal impairment: Since levetiracetam clearance is related to renal function, the dose should be individualized according to the patient’s renal function. Refer to the table below for dose adjustment in adults. Normal — Creatinine clearance ≥ 80 ml/min/1.73m2 — 500-1,500mg per dose — twice daily (12-hour intervals) Mild — Creatinine clearance 50-79 ml/min/1.73m2 — 500-1,000mg per dose — twice daily (12-hour intervals) Moderate — Creatinine clearance 30-49 ml/min/1.73m2 — 250-750mg per dose — twice daily (12-hour intervals) Severe — Creatinine clearance < 30 ml/min/1.73m2 — 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. 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, 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 impaired renal function.

Child dose

Monotherapy and adjunctive therapy for partial-onset seizures (4 years and older) — Children aged 4 to 11 years and adolescents aged 12 to 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 to 60mg/kg per day [30mg/kg per dose, twice daily]. Dose increases or decreases should not exceed 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. Children weighing 20kg or less: It is recommended to initiate treatment with the 100mg/ml oral solution. Children weighing 20 to 40kg: Start treatment at 500mg per day [250mg per dose, twice daily]; the dose may be increased by 500mg per day every 2 weeks, up to a maximum of 1500mg per day [750mg per dose, twice daily]. Children weighing more than 40kg: Start treatment at 1000mg per day [500mg per dose, twice daily]; the dose may be increased by 1000mg per day every 2 weeks, up to a maximum of 3000mg per day [1500mg per dose, twice daily]. Children weighing 50kg or more: The dose is the same as the adult dose. Monotherapy and adjunctive therapy for partial-onset seizures — Adolescents aged 12 to 17 years weighing 50kg or more: Start treatment with 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 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]. Adjunctive therapy for myoclonic seizures in pediatric patients (12 years and older): Start treatment with 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], 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 aged 12-17 years weighing 50kg or more: Start treatment with 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 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], 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 (12 years and older) — Adolescents aged 12-17 years weighing less than 50kg: Start treatment with 20mg/kg per day [10mg/kg per dose, twice daily]. The dose should be 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. 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) per dose twice daily Mild: Creatinine clearance 50-79 (ml/min/1.73m2) — 10-20mg/kg (0.10-0.20 ml/kg) per dose twice daily Moderate: Creatinine clearance 30-49 (ml/min/1.73m2) — 5-15mg/kg (0.05-0.15ml/kg) per dose twice daily Severe: Creatinine clearance < 30 (ml/min/1.73m2) — 5-10 mg/kg (0.05-0.10ml/kg) per dose twice daily End-stage renal disease patients on dialysis: Creatinine clearance -- — 10-20mg/kg (0.10-0.20 ml/kg) per dose 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. Use the following formula for infants, children, and adolescents. ks= 0.45 (infants younger than 1 year); ks= 0.55 (female children and adolescents younger than 13 years) ks= 0.7 (male adolescents) Children: The oral formulation is not recommended for infants younger than 1 month due to insufficient safety and efficacy data. Children 4 years and younger: Tablet administration is not applicable. Infants 1 month and older: The solution should be administered. Children younger than 16 years: Use of the injection is not recommended because safety and efficacy have not been established.

This medication is used for the treatment of epilepsy, and there may be an increased risk of suicidal thoughts or actions while taking it, so patients and caregivers should carefully monitor for these symptoms. Furthermore, this medication can cause various side effects related to the central nervous system, such as drowsiness, fatigue, coordination difficulties, and behavioral abnormalities, especially during the first four weeks of treatment. Abrupt discontinuation of the medication may worsen seizures, so the dose must be gradually reduced under a doctor's guidance. It should not be used in those with an allergy to this active ingredient or similar components, and patients with impaired kidney function may require dosage adjustments. Symptoms such as a decrease in blood cell count may occur during treatment, so if symptoms like weakness, fever, or infection arise, blood tests should be performed immediately. Psychiatric symptoms, behavioral changes, and aggression may occur, so if these changes are observed, seek consultation with a physician. Patients with heart disease or prolonged QT interval on an electrocardiogram should take care when using this medication. The risk to the fetus during pregnancy cannot be entirely excluded; therefore, women planning to become pregnant should consult with their healthcare provider. During breastfeeding, the medication may be transferred into breast milk and affect the infant; hence, a decision on continuing breastfeeding or discontinuing the medication should be made in consultation with a physician. Children and the elderly should also exercise caution when taking this medication, particularly the elderly with decreased kidney function, as they may need dosage adjustments. Caution should be exercised while performing tasks requiring concentration, such as driving or operating machinery, especially during the initial stages of taking this medication or when increasing the dose, as symptoms like drowsiness may occur. In cases of overdose, symptoms such as drowsiness, aggression, and decreased consciousness may appear, necessitating immediate medical attention. This medication has a low potential for drug interactions, but when used in conjunction with methotrexate, monitoring of blood concentration changes is necessary. When taking this medication, do not transfer it to another container and store it safely out of reach of children.

• suicidal impulses
• suicidal behavior
• depression
• abnormal changes in mood and behavior
• drowsiness
• fatigue
• cooperative movement disorders
• behavioral abnormalities
• asthenia
• psychotic symptoms

This medication should be stored in a tightly closed container to avoid exposure to air or moisture, and it is best kept at room temperature between 1°C and 30°C. Proper storage will help maintain the medication's effectiveness and prevent deterioration.

Appearance

Yellow oval film-coated tablet

Package unit

30 tablets/bottle