OnePRA 250 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. 2. Myoclonic seizures in pediatric patients (12 years and older) 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 (≥ 80): 500-1,500mg per dose, twice daily (12-hour intervals) Mild (50-79): 500-1,000mg per dose, twice daily (12-hour intervals) Moderate (30-49): 250-750mg per dose, twice daily (12-hour intervals) Severe (< 30): 250-500mg per dose, twice daily (12-hour intervals) End-stage renal disease patients on dialysis(1) (-): 500-1,000mg per dose, 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 weighing 50 kg or more (12-17 years) This medicine is initiated at 500mg twice daily. Depending on clinical response and tolerability, the dose may be increased or decreased every 2 to 4 weeks by 1000mg per day [500mg twice daily], up to the maximum recommended dose of 3000mg per day. Children 4 to 11 years of age and adolescents weighing less than 50 kg (12-17 years) The initial dose is 10mg/kg twice daily. Depending on clinical response and tolerability, the dose may be increased up to 60mg/kg per day [30mg/kg twice daily]; dose changes should not involve increases or decreases of more than 20mg/kg per day [10mg/kg twice daily] every 2 weeks. Use the lowest effective dose. The dose for children weighing 50 kg 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 20 kg 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. 2. Myoclonic seizures in pediatric patients (12 years and older) This medicine is initiated at 500mg twice daily. The dose is increased by 1,000mg per day every 2 weeks, up to the recommended daily dose of 3,000mg. Efficacy has not been studied at doses below 3,000mg per day. 3. Primary generalized tonic-clonic seizures (12 years and older) Adolescents weighing 50 kg or more (12-17 years) This medicine is initiated at 1,000mg per day [500mg twice daily]. The dose is increased by 1,000mg per day [500mg twice daily] every 2 weeks, up to the recommended daily dose of 3,000mg [1,500mg twice daily]. Efficacy has not been adequately studied at doses below 3,000mg per day. Adolescents weighing less than 50 kg (12-17 years) This medicine 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 has not been adequately studied at doses below 60mg/kg per day. 4. Patients with renal impairment For infants, children, and adolescents, use the following formulas. ks= 0.45 (infants under 1 year) ; ks= 0.55 (children and female adolescents under 13 years) ks= 0.7 (male adolescents) Dosage adjustment for pediatric patients and adolescents weighing less than 50 kg with renal impairment Normal (≥ 80): 10-30mg/kg per dose (0.10-0.30 ml/kg) twice daily Mild (50-79): 10-20mg/kg per dose (0.10-0.20 ml/kg) twice daily Moderate (30-49): 5-15mg/kg per dose (0.05-0.15ml/kg) twice daily Severe (< 30): 5-10 mg/kg per dose (0.05-0.10ml/kg) twice daily End-stage renal disease patients on dialysis (--): 10-20mg/kg per dose (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. Children The oral formulation is not recommended for infants younger than 1 month because of 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 and 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 treating epilepsy, and there is a risk of suicidal thoughts or behaviors, as well as mental health issues such as depression, during its use. Therefore, patients and caregivers should immediately inform healthcare professionals if such symptoms occur. Initial use may frequently cause drowsiness, fatigue, loss of motor coordination, and behavioral changes, and caution is advised. Abruptly stopping the medication can worsen seizures, so the dosage must be gradually reduced under a doctor's guidance. Patients with allergies to this drug or its components must not take it. Dosing adjustments may be necessary for patients with impaired kidney function, and renal function testing is recommended before use in cases of severe liver dysfunction. This medication may induce psychiatric symptoms such as aggression, agitation, and depression, requiring consultation with healthcare professionals if these symptoms arise. Rarely, abnormalities related to heart rhythm have been reported, necessitating caution in patients with heart disease or taking related medications. This drug may cause hematological adverse reactions such as decreased blood cell count, warranting blood tests if there are symptoms of fever or infection. Pregnant or planning to become pregnant women must consult healthcare professionals, and nursing mothers should consider stopping breastfeeding or the medication, as it may be transmitted through breast milk. Caution is necessary for pediatric and elderly patients, especially since children may experience behavioral changes more frequently. Drowsiness or decreased concentration may occur when driving or operating machinery, requiring caution. Overdose may result in vomiting, decreased consciousness, and respiratory depression, necessitating immediate medical attention. This drug has no significant interactions with other substances; however, caution is advised as co-administration with methotrexate may affect blood concentration. Finally, this medication should be stored out of reach of children in a safe place and should not be transferred to other containers.

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

This medication may be sensitive to air or moisture; therefore, it must be stored in a tightly sealed container. The recommended storage temperature is between 1 to 30 degrees Celsius. This helps maintain the effectiveness of the medication over time.

Appearance

Blue oval film-coated tablet

Package unit

Bottle packaging - 30 tablets/bottle