Onepraz Tablet 500 mg (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 by intravenous or oral administration. When switching from oral to intravenous administration or vice versa, the route may be changed directly without dose titration, and the total daily dose and frequency of administration should remain the same. Monotherapy — Adults and adolescents 16 years and older: The initial dose is 250mg per dose twice daily. After 2 weeks, increase to 500mg per dose twice daily. Depending on 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 medicine at 500mg per dose twice daily. Depending on 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. Adjunctive therapy — 3. Primary generalized tonic-clonic seizures (12 years and older) — Adults (18 years and older): Start this medicine 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 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 — As levetiracetam clearance is related to renal function, administer the medicine individually according to the patient's renal function. Refer to the table below for dose adjustment in adults. Dose adjustment for adults 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 administration. (2) An additional dose of 250-500mg is recommended after dialysis. 5. 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, if creatinine clearance is less than 60mL/min/1.73m2, it is advisable to reduce the daily maintenance dose by 50%. 7. Older adults (65 years and older) — Dose adjustment is recommended in older patients with reduced renal function.

Child dose

Adjunctive therapy — 1. Partial-onset seizures — Adolescents (12–17 years) weighing 50 kg or more: Start treatment with 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 aged 12–17 years weighing less than 50 kg: Start with an initial dose of 10mg/kg twice daily. Depending on clinical response and tolerability, the dose may be increased up to 60mg/kg/day [30mg/kg twice daily]. Dose adjustments must not exceed increases or decreases of 20mg/kg/day [10mg/kg twice daily] every 2 weeks. Use the lowest effective dose. The dosage for children weighing 50 kg or more is the same as the adult dosage. Body weight 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] Body weight 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] Body weight 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 50 kg or more are the same as for adults. Adjunctive therapy — 2. Myoclonic seizures in pediatric patients (12 years and older): Start treatment with 500mg twice daily. Increase the dose 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. Adjunctive therapy — 3. Primary generalized tonic-clonic seizures (12 years and older) — Adolescents (12-17 years) weighing 50 kg or more: Start treatment with 1,000mg/day [500mg twice daily]. Increase the dose 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 aged 12-17 years weighing less than 50 kg: Start treatment with 20mg/kg/day [10mg/kg twice daily]. Increase the dose 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. Use the following formula for infants, children, and adolescents. ks= 0.45 (infants under 1 year of age) ; ks= 0.55 (children and female adolescents under 13 years of age) ks= 0.7 (male adolescents) Dosage adjustment for pediatric patients and adolescents weighing less than 50 kg 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) 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 younger than 1 month due to insufficient safety and efficacy data. Tablets are not applicable for children 4 years of age or younger, and the oral solution should be administered to infants 1 month of age and older. The injection is not recommended for use in children younger than 16 years, as 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 suicidal thoughts or behaviors and mental health issues such as depression during use. Therefore, both patients and caregivers should immediately inform healthcare providers if such symptoms occur. This medication can affect the central nervous system, leading to symptoms such as drowsiness, fatigue, coordination difficulties, and behavioral changes, particularly more frequently within the first 4 weeks of treatment. Pediatric patients may also experience similar symptoms. When discontinuing use, the dosage should be gradually reduced according to a physician's instructions to prevent worsening seizures, as sudden cessation can be dangerous. Patients with allergies to the active substance or any components of this medication should not take it. Patients with compromised renal function may require dosage adjustments, and patients with severely impaired liver function should undergo renal function tests first. This medication may have side effects such as decreased blood cell counts. Therefore, if symptoms like fatigue, fever, or recurrent infections occur, blood tests should be performed. Psychiatric symptoms can include irritability, aggression, mood changes, and so on, and if such changes occur, consultation with the physician is necessary. Seizures may worsen at the beginning of treatment or when the dosage is increased, and if such symptoms occur, immediate consultation with healthcare providers is warranted. Patients with heart disease or abnormalities in their electrocardiogram should exercise caution. Women who are pregnant or planning to become pregnant should consult with healthcare providers, as sudden discontinuation can be harmful to both the fetus and the mother. If breastfeeding, this medication may be excreted in breast milk and affect the baby, so it is important to discuss whether to continue breastfeeding with healthcare providers. Elderly patients may have an increased risk of side effects due to renal function decline, and dosages should be determined carefully. Drowsiness or decreased concentration may occur when driving or operating machinery, so caution is needed. In case of overdose, symptoms such as drowsiness, aggression, decreased consciousness, and respiratory depression may occur, and immediate medical attention should be sought. This medication has relatively few drug interactions with other antiepileptics or oral contraceptives; however, caution is necessary with certain medications, so patients should inform their healthcare providers of all medications currently being taken. In children, safety has not been established for infants under 1 month old, and children under 4 years old should use the liquid formulation instead of tablets. This medication should be stored out of the reach of children and must not be transferred to other containers.

• Suicidal thoughts
• suicidal behavior
• depression
• abnormal changes in mood and behavior
• drowsiness
• fatigue
• coordination disorders
• behavioral abnormalities
• weakness
• aggression

This medication must be stored in a tightly closed container to prevent exposure to air or moisture. It is important to maintain storage temperatures between 1 degree and 30 degrees Celsius.

Appearance

Yellow oval film-coated tablet

Package unit

Bottle packaging - 30 tablets per bottle