Onepra Tablet 1000 mg (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 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 change may be made immediately without dose titration; the total daily dose and dosing frequency should remain the same. Monotherapy Adults and adolescents aged 16 years and older The initial dose is 250mg twice daily. After 2 weeks, increase the dose to 500mg twice daily. Depending on the clinical response, the dose may be increased by 500mg per day [250mg per dose, twice daily] every 2 weeks, up to a maximum dose of 3000mg per day [1500mg per dose, twice daily]. Adjunctive therapy 1. Partial-onset seizures Adults (18 years and older) Start this drug at 500mg twice daily. Depending on the clinical response and tolerability, the dose may be increased or decreased by 1000mg per day [500mg per dose, twice daily] every 2 to 4 weeks. The maximum recommended dose is 3000mg per day. 3. Primary generalized tonic-clonic seizures (12 years and older) Adults (18 years and older) Start this drug at 1,000mg per day [500mg per dose, twice daily]. Increase the dose by 1,000mg per day [500mg per dose, twice daily] every 2 weeks up to the recommended daily dose of 3,000mg [1,500mg per dose, twice daily]. Efficacy at doses below 3,000mg per day has not been adequately studied. 4. Patients with renal impairment Since levetiracetam clearance is related to renal function, administer the drug individually according to the patient's renal function. Refer to the table below for dose adjustment in adults. Dose adjustment in adult patients with renal impairment Normal: Creatinine clearance ≥ 80 mL/min/1.73m2, dose per administration 500-1,500mg, twice daily (12-hour intervals) Mild: Creatinine clearance 50-79 mL/min/1.73m2, dose per administration 500-1,000mg, twice daily (12-hour intervals) Moderate: Creatinine clearance 30-49 mL/min/1.73m2, dose per administration 250-750mg, twice daily (12-hour intervals) Severe: Creatinine clearance < 30 mL/min/1.73m2, dose per administration 250-500mg, twice daily (12-hour intervals) End-stage renal disease patients on dialysis (1): Creatinine clearance -, 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 failure. Therefore, if 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 older patients with impaired renal function.

Child dose

Adjunctive therapy 1. Partial-onset seizures Adolescents weighing 50kg or more (12-17 years) Treatment is initiated at 500mg twice daily. Depending on clinical response and tolerability, the dose may be increased or decreased by 1000mg/day [500mg twice daily] every 2 to 4 weeks. The maximum recommended dose is 3000mg/day. 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/day [30mg/kg twice daily]. Dose adjustments should not exceed increases or decreases of 20mg/kg/day [10mg/kg twice daily] every 2 weeks. Use the lowest effective dose. The dose for children weighing 50kg or more is the same as the adult dose. 15-20kg(1): 20mg/kg/day (twice daily) 300mg-400mg/day [150-200mg twice daily]; 40mg/kg/day (twice daily) 600mg-800mg/day [300-400mg twice daily]; 60mg/kg/day (twice daily) 900mg-1,200mg/day [450-600mg twice daily] 20.1-40kg: 20mg/kg/day (twice daily) 500mg/day [250mg twice daily]; 40mg/kg/day (twice daily) 1,000mg/day [500mg twice daily]; 60mg/kg/day (twice daily) 1,500mg/day [750mg twice daily] 40.1-50kg(2): 20mg/kg/day (twice daily) 1,000mg/day [500mg twice daily]; 40mg/kg/day (twice daily) 2,000mg/day [1,000mg twice daily]; 60mg/kg/day (twice daily) 3,000mg/day [1,500mg twice daily] (1) For children weighing 20kg or less, it is recommended to initiate treatment with the 100mg/mL oral solution. (2) The dosage and administration for children and adolescents weighing 50kg or more are the same as for adults. 2. Myoclonic seizures in pediatric patients (12 years and older) Treatment is initiated at 500mg twice daily. The dose is increased by 1,000mg/day every 2 weeks to the recommended daily dose of 3,000mg. Efficacy at doses below 3,000mg/day has not been studied. 3. Primary generalized tonic-clonic seizures (12 years and older) Adolescents weighing 50kg or more (12-17 years) Treatment is initiated at 1,000mg/day [500mg twice daily]. The dose is increased by 1,000mg/day [500mg twice daily] every 2 weeks to the recommended daily dose of 3,000mg [1,500mg twice daily]. Efficacy at doses below 3,000mg/day has not been adequately studied. Adolescents weighing less than 50kg (12-17 years) Treatment is initiated at 20mg/kg/day [10mg/kg twice daily]. The dose is increased by 20mg/kg/day [10mg/kg twice daily] every 2 weeks to the recommended daily dose of 60mg/kg [30mg/kg twice daily]. Efficacy at doses below 60mg/kg/day has not been adequately studied. 4. Patients with renal impairment Use the following formula for infants, children, and adolescents. ks= 0.45 (infants under 1 year) ; ks= 0.55 (children under 13 years and female adolescents) ks= 0.7 (male adolescents) Dosage adjustment for 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) twice daily Mild: Creatinine clearance 50-79 (ml/min/1.73m2), 10-20mg/kg(0.10-0.20 ml/kg) twice daily Moderate: Creatinine clearance 30-49 (ml/min/1.73m2), 5-15mg/kg (0.05-0.15ml/kg) twice daily Severe: Creatinine clearance < 30 (ml/min/1.73m2), 5-10 mg/kg (0.05-0.10ml/kg) twice daily End-stage renal disease patients on dialysis: Creatinine clearance --, 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) An additional dose of 5-10 mg/kg(0.05-0.10ml/kg) is recommended after dialysis. 6. Pediatric patients The oral formulation is not recommended for infants under 1 month of age because of insufficient safety and efficacy data. Tablet administration is not applicable in children 4 years or younger, and the oral solution should be administered to infants aged 1 month or older. The injection is not recommended for children under 16 years of age because its safety and efficacy have not been established.

This medication is used for the treatment of epilepsy, and there is an increased risk of developing mental health issues such as suicidal thoughts or behavior and depression during treatment. Therefore, patients and caregivers should notify healthcare professionals immediately if changes in mood or abnormal behavior occur. This medication may cause central nervous system side effects, including drowsiness, fatigue, coordination disorders, and behavioral abnormalities, particularly within the first 4 weeks of treatment. Reports of drowsiness and behavioral abnormalities have also been noted in children and require caution. Abrupt discontinuation of this medication may worsen seizures, so the dosage should be gradually reduced according to physician's instructions. Patients with allergies to the active ingredient or any components of this medication should not use it. Patients with poor kidney function may require dosage adjustments before administration, and patients with severe liver damage should undergo kidney function tests first. This medication may have side effects related to reduced blood cell counts, and blood tests may be necessary if symptoms such as lethargy, fever, or signs of infection appear. Psychiatric symptoms such as irritability, aggressiveness, depression, and anxiety may occur; therefore, consult healthcare providers if such changes arise. The possibility of exacerbating seizures exists during the early stages of treatment or when increasing the dosage, so consultation with a physician is necessary if symptoms occur. Patients with heart disease or at risk for QT interval prolongation should exercise caution. This medication has relatively low drug interactions with other antiepileptic drugs, oral contraceptives, digoxin, and warfarin, but caution is advised when used with methotrexate due to potential changes in blood concentration. The risks to the fetus cannot be completely excluded during pregnancy; therefore, women planning to become pregnant should consult with healthcare providers to review treatment; likewise, during breastfeeding, the drug may transfer through breast milk and affect the infant, and alternatives should be considered to discontinue breastfeeding or the use of this medication. Safety in infants under 1-month-old has not been established, and children under 4 years should use solutions instead of tablets. Elderly patients may have an increased risk of side effects due to decreased kidney function, requiring careful dosage adjustment. Caution is needed when driving or operating machinery due to potential drowsiness or decreased concentration. Overdose may result in drowsiness, agitation, aggressiveness, and decreased consciousness; there is no specific antidote, so immediate medical attention is necessary. This medication should be stored in an appropriate container and kept out of reach of children.

• suicidal impulses
• suicidal behavior
• depression
• drowsiness
• fatigue
• coordination dysfunction
• behavioral abnormalities
• weakness
• aggression
• restlessness

Store this medication in a tightly sealed container to protect it from air and moisture. It is recommended to maintain storage temperatures between 1 degree and 30 degrees Celsius. This will help preserve the medication's efficacy over time.

Appearance

White oval film-coated tablet

Package unit

Bottle packaging - 30 tablets/bottle