Keppra Tablet 500mg (Levetiracetam)

Adult dose

Film-coated tablets and oral solution are administered orally and may be taken with or without food. Take with plenty of water. The daily dose should be divided into 2 equal doses and administered twice daily. Levetiracetam treatment may be initiated intravenously or orally. When switching from oral to intravenous administration or vice versa, the change may be made 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 of age and older) and adolescents weighing 50kg or more (12~17 years): Start this drug 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]. The maximum recommended dose is 3000mg per day [1500mg per dose, twice daily]. Adjunctive therapy for myoclonic seizures in pediatric patients (12 years of age and older): Start this drug 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]. The maximum recommended dose is 3000mg per day [1500mg per dose, twice daily]. Efficacy has not been studied at doses below 3,000mg per day. Adjunctive therapy for primary generalized tonic-clonic seizures (12 years of age and older) Adults (18 years of age and older) and adolescents weighing 50kg or more (12-17 years): Start this drug 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]. The maximum recommended dose is 3000mg per day [1500mg per dose, twice daily]. Efficacy has not been adequately studied at doses below 3,000mg per day. Patients with renal impairment: Since levetiracetam clearance is related to renal function, administer an individualized dose according to the patient's renal function. Normal, ≧ 80 ml/min/1.73m2: 500-1,500mg per dose, twice daily (12-hour interval) Mild, 50-79 ml/min/1.73m2: 500-1,000mg per dose, twice daily (12-hour interval) Moderate, 30-49 ml/min/1.73m2: 250-750mg per dose, twice daily (12-hour interval) Severe, < 30 ml/min/1.73m2: 250-500mg per dose, twice daily (12-hour interval) 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 administration. (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, if creatinine clearance is below 60mL/min/1.73m2, a 50% reduction in the daily maintenance dose is recommended. Elderly patients (65 years of age 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 of age and older) Children 4~11 years of age and adolescents 12~17 years of age weighing less than 50kg: Start with an initial dose of 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 changes should not exceed an increase or decrease 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. Children weighing 20kg or less: It is recommended to initiate treatment with the 100mg/ml oral solution. Children weighing 20~40kg: Start at 500mg per day [250mg per dose, twice daily], increasing by 500mg per day every 2 weeks to a maximum of 1500mg per day [750mg per dose, twice daily]. Children weighing more than 40kg: Start at 1000mg per day [500mg per dose, twice daily], increasing by 1000mg per day every 2 weeks 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. Adjunctive therapy for primary generalized tonic-clonic seizures (12 years of age and older) Adolescents 12-17 years of age weighing less than 50kg: Start this drug at 20mg/kg per day [10mg/kg per dose, twice daily]. Increase the dose 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. Dose adjustment for pediatric patients and adolescents weighing less than 50kg with renal impairment Normal, ≧ 80 (ml/min/1.73m2): 10-30mg/kg (0.10-0.30 ml/kg) per dose, twice daily Mild, 50-79 (ml/min/1.73m2): 10-20mg/kg (0.10-0.20 ml/kg) per dose, twice daily Moderate, 30-49 (ml/min/1.73m2): 5-15mg/kg (0.05-0.15ml/kg) per dose, twice daily Severe, < 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, --: 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 administration. (2) An additional dose of 5-10 mg/kg (0.05-0.10ml/kg) is recommended after dialysis. ks= 0.45 (infants under 1 year of age) ks= 0.55 (children under 13 years of age and female adolescents) ks= 0.7 (male adolescents) Oral formulations are not recommended for infants under 1 month of age because of insufficient safety and efficacy data. Tablet administration is not applicable to children 4 years of age or younger; the oral solution should be administered to infants 1 month of age and older. Injection is not recommended for children under 16 years of age because its safety and efficacy have not been established.

This medication may increase the risk of suicidal thoughts or behaviors, so if symptoms of depression, mood changes, or unusual behaviors occur during treatment, it is essential to consult a physician. This medication can affect the central nervous system and may cause symptoms such as drowsiness, fatigue, coordination difficulties, and behavioral abnormalities, especially within the first 4 weeks of treatment. Abrupt discontinuation of this medication may worsen seizures, so dosage should be gradually reduced under the supervision of a physician. Patients with hypersensitivity to this medication's components or specific genetic conditions such as lactose intolerance should not use this medication. Patients with a history of depression or suicidal thoughts, or those with poor renal function should be especially cautious while using this medication, and blood tests may be necessary to monitor blood cell counts. This medication may induce psychiatric symptoms such as aggression, agitation, and anxiety, so if such symptoms occur, it's important to consult a physician to consider dosage adjustments or discontinuation of treatment. Care should be taken as seizures may worsen, especially when first taking this medication or increasing the dose. Patients with heart disease or electrolyte imbalances should undergo an electrocardiogram (ECG), and this medication should be used cautiously due to the risk of QT interval prolongation. Drowsiness or dizziness may occur during treatment, so it is advisable to avoid hazardous activities such as driving or operating machinery. Women who are pregnant or planning to become pregnant should consult healthcare professionals before taking this medication, and breastfeeding may need to be reconsidered as the medication can be excreted in breast milk. Children and elderly patients may require dose adjustments based on renal function, and the use of this medication in infants under 1 month or children under 4 years old is not recommended. This medication has relatively few drug interactions, but care should be taken when used with medications such as methotrexate, monitoring blood concentrations closely. In case of overdose, the medication should be removed via vomiting or gastric lavage, and if necessary, blood dialysis may be employed, as there is no specific antidote. Serious side effects such as rash, liver dysfunction, blood abnormalities, and severe allergic reactions may rarely occur; therefore, if any abnormal symptoms appear, immediate medical attention should be sought.

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

This medication can be sensitive to air and moisture; therefore, it should be stored in a tightly sealed container. Maintaining the storage temperature between 1 and 30 degrees Celsius is important. By doing so, the efficacy and safety of the medication can be preserved for an extended period.

Appearance

Yellow oval film-coated tablet

Package unit

For domestic use: 60 tablets (10 tablets/PTP × 6), 30 tablets/bottle, 100 tablets/bottle For export: 30 tablets (10 tablets/PTP × 3)