Onepraz Tablet 750mg (Levetiracetam)

Adult dose

Film-coated tablets and oral solution are administered orally and may be taken regardless of meals, with a sufficient amount 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 changing the route of administration from oral to intravenous or vice versa, the drug may be administered immediately without dose titration; the same total daily dose and dosing frequency should be maintained. 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 clinical response, the dose may be increased by 500mg/day [250mg per dose, twice daily] every 2 weeks; the maximum dose is 3000mg/day [1500mg per dose, twice daily]. Adjunctive therapy 1. Partial-onset seizures Adults (18 years and older) and 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 per dose, twice daily] every 2 to 4 weeks; the maximum recommended dose is 3000mg/day. The dose for children weighing 50kg or more is the same as the adult dose. 3. Primary generalized tonic-clonic seizures (12 years and older) Adults (18 years and older) and adolescents weighing 50kg or more (12-17 years) Treatment is initiated at 1,000mg/day [500mg per dose, twice daily]. The dose is increased by 1,000mg/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/day has not been adequately studied. 4. Patients with renal impairment Since levetiracetam clearance is related to renal function, administer an individualized dose according to the patient's renal function. Refer to the table below for dose adjustment in adults. Dose adjustment for 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) After dialysis, an additional dose of 250-500mg is recommended. 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, when creatinine clearance is less than 60mL/min/1.73m2, it is recommended that the daily maintenance dose be reduced by 50%. 7. Elderly patients (65 years and older) Dose adjustment is recommended in elderly patients with reduced renal function.

Child dose

Children aged 4 years~11 years and adolescents aged 12~17 years weighing less than 50kg The initial dose is 10mg/kg twice daily. Depending on clinical response and tolerability, the dose may be increased up to 60mg/kg/day [30mg/kg per dose, twice daily]. Dose changes should not exceed increases or decreases of 20mg/kg/day [10mg/kg per dose, twice daily] every 2 weeks. Use the lowest effective dose. Recommended doses for children and adolescents 15-20kg(1): 20mg/kg/day (twice daily) 300mg-400mg/day [150-200mg per dose twice daily]; 40mg/kg/day (twice daily) 600mg-800mg/day [300-400mg per dose twice daily]; 60mg/kg/day (twice daily) 900mg-1,200mg/day [450-600mg per dose twice daily] 20.1-40kg: 20mg/kg/day (twice daily) 500mg/day [250mg per dose, twice daily]; 40mg/kg/day (twice daily) 1,000mg/day [500mg per dose, twice daily]; 60mg/kg/day (twice daily) 1,500mg/day [750mg per dose, twice daily] 40.1-50kg(2): 20mg/kg/day (twice daily) 1,000mg/day [500mg per dose, twice daily]; 40mg/kg/day (twice daily) 2,000mg/day [1,000mg per dose, twice daily]; 60mg/kg/day (twice daily) 3,000mg/day [1,500mg per dose, 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, up 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 aged 12-17 years weighing less than 50kg Treatment is initiated 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, up 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. For infants, children, and adolescents, use the following formula. ks= 0.45 (infants under 1 year) ks= 0.55 (children under 13 years and female adolescents) ks= 0.7 (male adolescents) Dose adjustment for children and adolescents weighing less than 50kg with renal impairment Normal: Creatinine clearance ≥ 80 (ml/min/1.73m2), dose per administration and regimen 10-30mg/kg(0.10-0.30 ml/kg) twice daily Mild: Creatinine clearance 50-79 (ml/min/1.73m2), dose per administration and regimen 10-20mg/kg(0.10-0.20 ml/kg) twice daily Moderate: Creatinine clearance 30-49 (ml/min/1.73m2), dose per administration and regimen 5-15mg/kg (0.05-0.15ml/kg) twice daily Severe: Creatinine clearance < 30 (ml/min/1.73m2), dose per administration and regimen 5-10 mg/kg (0.05-0.10ml/kg) twice daily End-stage renal disease patients on dialysis: Creatinine clearance --, dose per administration and regimen 10-20mg/kg(0.10-0.20 ml/kg) once daily(1)(2) (1) A loading dose of 15 mg/kg(0.15ml/kg) is recommended on the first day of treatment. (2) After dialysis, an additional dose of 5-10 mg/kg(0.05-0.10ml/kg) is recommended. 6. Pediatric patients Oral formulations are not recommended for infants younger than 1 month because of insufficient safety and efficacy data. Tablets are not indicated for children 4 years and younger; the oral solution should be administered to infants 1 month and older. Injection is not recommended for children under 16 years because safety and efficacy have not been established.

This medication may increase the risk of suicidal thoughts or behavior, so close monitoring for depression, mood changes, and abnormal behavior is necessary during treatment. It may cause sedation, fatigue, coordination problems, and behavioral abnormalities affecting the central nervous system, especially when first starting the medication or adjusting the dosage. Abrupt discontinuation of the medication may worsen seizures, so doses should be gradually reduced under medical guidance. Patients with allergies to the ingredients of this medication should not take it, and those with impaired kidney function may require dose adjustments. Psychiatric symptoms, aggression, irritability, and other changes may occur; if these symptoms appear, contact healthcare personnel immediately. Precaution is advised in patients with heart disease or electrolyte imbalances due to the risk of QT interval prolongation on the ECG. Women who are pregnant or planning to become pregnant should consult with healthcare personnel about the use of this medication, and breastfeeding mothers should consider stopping breastfeeding or discontinuing the medication, as it can be transmitted through breast milk. Caution is also advised regarding drowsiness or decreased concentration when driving or operating machinery. In cases of overdose, symptoms such as drowsiness, aggression, and decreased consciousness may appear, and immediate emergency treatment is required. This medication has relatively few interactions with other drugs, but caution is needed when co-administered with certain medications; inform healthcare personnel of any other medications being taken. Care should be taken when administering to children and the elderly, especially elderly patients with reduced kidney function, who may require dose adjustments. If any adverse reactions occur during treatment with this medication, inform healthcare personnel immediately for appropriate actions.

• suicidal impulses
• suicidal behavior
• depression
• abnormal changes in mood and behavior
• drowsiness
• fatigue
• coordination disorders
• abnormal behavior
• weakness
• aggression

This medication should be stored in a tightly closed container to prevent air or moisture from entering. Additionally, it should be kept at room temperature between 1 and 30 degrees Celsius, away from extreme heat or cold.

Appearance

Orange oval film-coated tablet

Package unit

Bottle packaging - 30 tablets/bottle