Keppra 500mg (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. 1. 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]. 2. Adjunctive therapy for myoclonic seizures in pediatric patients 3. 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 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. 4. 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: dose per administration 500-1,500mg, twice daily (12-hour intervals) Mild, 50-79 ml/min/1.73m2: dose per administration 500-1,000mg, twice daily (12-hour intervals) Moderate, 30-49 ml/min/1.73m2: dose per administration 250-750mg, twice daily (12-hour intervals) Severe, < 30 ml/min/1.73m2: dose per administration 250-500mg, twice daily (12-hour intervals) End-stage renal disease patients on dialysis(1), -: dose per administration 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

1. Monotherapy and adjunctive therapy for partial-onset seizures (4 years and older) Adolescents weighing 50kg or more (12~17 years): Treatment with this drug 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 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 twice daily] or 1000mg per day [500mg twice daily], and the maximum recommended dose is 3000mg per day [1500mg twice daily]. Children aged 4~11 years and adolescents weighing less than 50kg (12~17 years): The initial dose is 10mg/kg twice daily. Depending on clinical response and tolerability, the dose may be increased to 60mg/kg per day [30mg/kg twice daily]; dose adjustments should not exceed an increase or decrease of 20mg/kg per day [10mg/kg 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: Treatment is initiated at 500mg per day [250mg twice daily] and may be increased by 500mg per day every 2 weeks, up to a maximum of 1500mg per day [750mg twice daily]. Children weighing more than 40kg: Treatment is initiated at 1000mg per day [500mg twice daily] and may be increased by 1000mg per day every 2 weeks, up to a maximum of 3000mg per day [1500mg twice daily]. Children weighing 50kg or more: The dose is the same as the adult dose. 2. Adjunctive therapy for myoclonic seizures in pediatric patients (12 years and older) 12 years and older: Treatment with this drug 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 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 twice daily] or 1000mg per day [500mg twice daily], and the maximum recommended dose is 3000mg per day [1500mg twice daily]. Efficacy at doses below 3,000mg per day has not been studied. 3. Adjunctive therapy for primary generalized tonic-clonic seizures (12 years and older) Adolescents weighing 50kg or more (12-17 years): Treatment with this drug is initiated at 1,000mg per day [500mg twice daily]. However, based on the physician’s assessment of potential adverse reactions relative 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 twice daily] or 1000mg per day [500mg twice daily], and the maximum recommended dose is 3000mg per day [1500mg twice daily]. Efficacy at doses below 3,000mg per day has not been adequately studied. Adolescents weighing less than 50kg (12-17 years): Treatment with this drug is initiated at 20mg/kg per day [10mg/kg twice daily]. The dose is increased by 20mg/kg per day [10mg/kg twice daily] every 2 weeks, up to the recommended daily dose of 60mg/kg [30mg/kg twice daily]. Efficacy at doses below 60mg/kg per day has not been adequately studied. Dosage 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) 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 treatment, 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 female adolescents under 13 years) ks= 0.7 (male adolescents) 6. Children The oral formulation is not recommended for infants under 1 month of age due to 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 or older. Administration of the injection is not recommended in children under 16 years of age, as its safety and efficacy have not been established.

This medication may increase the risk of suicidal thoughts or behaviors, so if mood changes or symptoms of depression occur during treatment, the healthcare provider must be notified immediately. Central nervous system side effects such as drowsiness, fatigue, coordination disturbances, and behavioral changes may frequently occur within the first four weeks of treatment, so caution is advised. Abrupt discontinuation of the medication may exacerbate seizures, hence the dosage should be gradually reduced according to the physician's instructions. This medication should not be taken if there is an allergy to this drug or any of its components. Patients with suicidal thoughts or symptoms of depression should be closely monitored, and if abnormal behavior or aggression occurs, consultation with a healthcare provider is necessary. Patients with impaired renal function may require dosage adjustments and should consult with their physician. Patients with heart disease or those at risk for QT interval prolongation should exercise caution while taking this medication. This medication may cause drowsiness and fatigue, so caution is advised when driving or operating machinery, especially during the initial treatment phase or when increasing the dosage. Women who are pregnant or are planning to become pregnant should discuss the use of this medication with a healthcare provider, and breastfeeding mothers should consider discontinuing breastfeeding or reassessing medication use, as the drug can pass into breast milk. Special precautions are necessary for children or the elderly, especially elderly individuals with reduced renal function who must have their dosages carefully adjusted. During the use of this medication, if any signs of hypersensitivity such as rash, fever, or lymphadenopathy emerge, healthcare providers should be informed immediately, and if necessary, discontinuation of the drug should be considered. Interactions with other drugs are relatively few, but monitoring of blood concentration is required when used in conjunction with methotrexate, so all medications currently being taken should be disclosed to the physician. In case of overdose, measures such as vomiting or gastric lavage may be needed to remove the drug, and if necessary, treatment such as blood dialysis should be administered. When storing the medication, ensure it is kept in a tightly closed container out of reach of children and not transferred to another container.

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

This medication should be stored in a tightly sealed container to prevent air and moisture ingress. It is best to maintain storage temperatures between 1 degree and 30 degrees Celsius. This will help preserve the efficacy of the medication for a longer period.

Appearance

Yellow oval film-coated tablet

Package unit

60 tablets (10 tablets * 6 PTP)