Rebira 250 mg (Levetiracetam)

Adult dose

The film-coated tablets and oral solution are taken by mouth and may be taken with or without food. Take with plenty of water. The daily dose is divided into 2 equal doses and administered twice daily. Levetiracetam treatment may be initiated by intravenous or oral administration. When switching from oral to intravenous administration or vice versa, the 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 is initiated at 500mg twice daily. 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/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) — Treatment is initiated at 500mg twice daily. 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/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 is initiated at 1,000mg/day [500mg per dose, twice daily]. 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/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: Because levetiracetam clearance is related to renal function, administer individually according to the patient's renal function. Adult patients with renal impairment — Normal (creatinine clearance ≥ 80 mL/min/1.73m2): 500-1,500mg per dose, twice daily (12-hour intervals) Adult patients with renal impairment — Mild (creatinine clearance 50-79 mL/min/1.73m2): 500-1,000mg per dose, twice daily (12-hour intervals) Adult patients with renal impairment — Moderate (creatinine clearance 30-49 mL/min/1.73m2): 250-750mg per dose, twice daily (12-hour intervals) Adult patients with renal impairment — Severe (creatinine clearance < 30 mL/min/1.73m2): 250-500mg per dose, twice daily (12-hour intervals) Adult patients with renal impairment — End-stage renal disease patients on dialysis: 500-1,000mg per dose, once daily. An initial loading dose of 750mg is recommended on the first day of treatment. An additional dose of 250-500mg is recommended after dialysis. Patients with hepatic impairment: No dose adjustment is required 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 to reduce the daily maintenance dose 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 50 kg — The initial dose is 10 mg/kg per dose twice daily. Depending on clinical response and tolerability, the dose may be increased to 60 mg/kg/day [30 mg/kg per dose twice daily]. Dose changes should not exceed increases or decreases of 20 mg/kg/day [10 mg/kg per dose twice daily] every 2 weeks. Use the lowest effective dose. The maximum recommended dose is 3000mg/day. Children weighing 20 kg or less — It is recommended to initiate treatment with the 100mg/ml oral solution. Children weighing 20 to 40 kg — Initiate treatment at 500mg/day [250mg per dose twice daily]; the dose may be increased by 500mg/day every 2 weeks to a maximum of 1500mg/day [750mg per dose twice daily]. Children weighing more than 40 kg — Initiate treatment at 1000mg/day [500mg per dose twice daily]; the dose may be increased by 1000mg/day every 2 weeks to a maximum of 3000mg/day [1500mg per dose twice daily]. Children weighing 50 kg or more — The dose is the same as the adult dose. Adolescents aged 12 to 17 years weighing 50 kg or more — Initiate treatment at 500mg per dose twice daily. Based on the physician’s assessment of potential adverse reactions relative to seizure reduction, the initial dose may be reduced 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/day [250mg per dose twice daily] or 1000mg/day [500mg per dose twice daily], with a maximum recommended dose of 3000mg/day [1500mg per dose twice daily]. Adjunctive therapy for myoclonic seizures in pediatric patients (12 years and older) — Initiate treatment at 500mg per dose twice daily. Based on the physician’s assessment of potential adverse reactions relative to seizure reduction, the initial dose may be reduced 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/day [250mg per dose twice daily] or 1000mg/day [500mg per dose twice daily], with a maximum recommended dose of 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) Adolescents aged 12-17 years weighing 50 kg or more — Initiate treatment at 1,000mg/day [500mg per dose twice daily]. Based on the physician’s assessment of potential adverse reactions relative to seizure reduction, the initial dose may be reduced 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/day [250mg per dose twice daily] or 1000mg/day [500mg per dose twice daily], with a maximum recommended dose of 3000mg/day [1500mg per dose twice daily]. Efficacy at doses below 3,000mg/day has not been adequately studied. Adolescents aged 12-17 years weighing less than 50 kg — Initiate treatment at 20mg/kg/day [10mg/kg per dose twice daily]. The dose is increased by 20mg/kg/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/day has not been adequately studied. Renal impairment in infants, children, and adolescents: ks= 0.45 (infants under 1 year); ks= 0.55 (children and female adolescents under 13 years) Pediatric patients with renal impairment and adolescents weighing less than 50 kg — Normal (creatinine clearance ≥ 80 ml/min/1.73m2): 10-30mg/kg(0.10-0.30 ml/kg) twice daily Pediatric patients with renal impairment and adolescents weighing less than 50 kg — Mild (creatinine clearance 50-79 ml/min/1.73m2): 10-20mg/kg(0.10-0.20 ml/kg) twice daily Pediatric patients with renal impairment and adolescents weighing less than 50 kg — Moderate (creatinine clearance 30-49 ml/min/1.73m2): 5-15mg/kg (0.05-0.15ml/kg) twice daily Pediatric patients with renal impairment and adolescents weighing less than 50 kg — Severe (creatinine clearance < 30 ml/min/1.73m2): 5-10 mg/kg (0.05-0.10ml/kg) twice daily Pediatric patients with renal impairment and adolescents weighing less than 50 kg — End-stage renal disease patients on dialysis: 10-20mg/kg(0.10-0.20 ml/kg) once daily. A loading dose of 15 mg/kg(0.15ml/kg) is recommended on the first day of treatment. After dialysis, an additional dose of 5-10 mg/kg(0.05-0.10ml/kg) is recommended. Infants under 1 month — Oral formulations are not recommended due to insufficient safety and efficacy data. Children 4 years and younger — Tablets are not applicable; infants 1 month and older should be given the oral solution. Children under 16 years — Injection is not recommended because safety and efficacy have not been established.

This medication is used for the treatment of epilepsy and may increase the risk of suicidal thoughts or behavior and mental health issues such as depression during use. Therefore, patients or caregivers must inform healthcare professionals immediately if these symptoms occur. This medication may cause central nervous system side effects such as drowsiness, fatigue, coordination impairment, and behavioral changes, especially within the first four weeks of treatment. Care must be taken particularly in children and patients aged 6 years and older due to the potential for behavioral disorders. Discontinuing this medication abruptly may worsen seizures, so the dosage should be gradually reduced before stopping. Patients who are allergic to this medication or its components should not use it. Patients with impaired kidney function may require dosage adjustments, and those with severe liver dysfunction should undergo renal function testing. This medication contains a pigment called Yellow No. 5, so caution is warranted for those allergic to it. There may be side effects of reduced blood cell counts, so patients should have blood tests if they experience weakness, fever, or signs of infection. This medication may induce psychiatric symptoms such as irritability and aggression, so changes in mood or behavior should be discussed with healthcare providers. Seizures may worsen during the initial treatment stages or when increasing the dosage, and immediate consultation with a doctor is necessary if such symptoms appear. Patients with heart disease or electrolyte imbalances should be cautious as there is a risk of QT interval prolongation on an electrocardiogram. During pregnancy, this medication should be used with caution due to potential effects on the fetus, and during breastfeeding, consideration should be given to stopping breastfeeding or discontinuing the medication as the drug may be transmitted through breast milk. For children, safety has not been established for infants under 1 month, and it is recommended to use a liquid formulation instead of tablets for children under 4 years old. Elderly patients may have decreased kidney function, so dosage should be adjusted cautiously, and care is needed due to central nervous system side effects such as drowsiness while driving or operating machinery. In cases of overdose, symptoms such as drowsiness, agitation, decreased consciousness, and respiratory depression may occur, and treatment should be symptom-specific as there is no specific antidote. This medication tends to have fewer drug interactions when combined with other epilepsy treatments or oral contraceptives, but caution is needed for blood concentration changes when used with methotrexate. If any adverse reactions occur while taking this medication, patients should consult a healthcare provider immediately and must adhere strictly to the prescribed dosage and regimen.

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

This medication should be stored in a tightly closed container to protect it from exposure to air and moisture and should be kept at room temperature between 1 and 30 degrees Celsius. Proper storage will ensure the medication's efficacy is preserved safely.

Appearance

Blue oval film-coated tablet

Package unit

60 tablets/box [10 tablets/PTPX6]