Donggu Levetiracetam 500 mg

Adult dose

Film-coated tablets and oral solution are administered orally, may be taken with or without food, and should be taken with a sufficient amount of water. The total 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, treatment may be switched directly without dose titration; the total daily dose and frequency of administration 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/day [250mg per dose, twice daily] every 2 weeks; the maximum dose is 3000mg/day [1500mg per dose, twice daily]. Adjunctive therapy - Partial-onset seizures, adults (18 years and older) and adolescents weighing 50kg or more (12~17 years): Start this medication 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. Adjunctive therapy - Myoclonic seizures in pediatric patients (12 years and older): Start this medication at 500mg twice daily. Increase the dose by 1,000mg/day every 2 weeks to the recommended daily dose of 3,000mg. Efficacy has not been studied at doses below 3,000mg/day. Adjunctive therapy - Primary generalized tonic-clonic seizures (12 years and older), adults (18 years and older) and adolescents weighing 50kg or more (12-17 years): Start this medication at 1,000mg/day [500mg per dose, twice daily]. Increase the dose by 1,000mg/day [500mg per dose, twice daily] every 2 weeks to the recommended daily dose of 3,000mg [1,500mg per dose, twice daily]. Efficacy has not been adequately studied at doses below 3,000mg/day. Patients with renal impairment: Since levetiracetam clearance is related to renal function, adjust the dose individually 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: 500-1,500mg per dose, twice daily (12-hour intervals) Mild, creatinine clearance 50-79 ml/min/1.73m2: 500-1,000mg per dose, twice daily (12-hour intervals) Moderate, creatinine clearance 30-49 ml/min/1.73m2: 250-750mg per dose, twice daily (12-hour intervals) Severe, creatinine clearance < 30 ml/min/1.73m2: 250-500mg per dose, twice daily (12-hour intervals) End-stage renal disease patients on dialysis(1), creatinine clearance -: 500-1,000mg per dose, 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. 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%. Older adults (65 years and older): Dose adjustment is recommended in older patients with reduced renal function.

Child dose

Adjunctive therapy - Partial-onset seizures, children aged 4 years to 11 years and adolescents aged 12~17 years weighing less than 50kg: Start with an initial dose of 10mg/kg per dose, twice daily. Depending on clinical response and tolerability, the dose may be increased to 60mg/kg/day [30mg/kg per dose, twice daily]. Dose changes should not exceed an increase or decrease of 20mg/kg/day [10mg/kg per dose, twice daily] every 2 weeks. Use the lowest effective dose. Body weight 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] Body weight 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] Body weight 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. The dose for children weighing 50kg or more is the same as the adult dose. (2) The dosage and administration for children and adolescents weighing 50kg or more are the same as for adults. Adjunctive therapy - Primary generalized tonic-clonic seizures (12 years and older), adolescents aged 12-17 years weighing less than 50kg: Start this medication at 20mg/kg/day [10mg/kg per dose, twice daily]. Increase the dose 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 has not been adequately studied at doses below 60mg/kg/day. 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 Pediatric patients and adolescents weighing less than 50kg with renal impairment, mild (creatinine clearance 50-79 ml/min/1.73m2): 10-20mg/kg (0.10-0.20 ml/kg) twice daily Pediatric patients and adolescents weighing less than 50kg with renal impairment, moderate (creatinine clearance 30-49 ml/min/1.73m2): 5-15mg/kg (0.05-0.15ml/kg) twice daily Pediatric patients and adolescents weighing less than 50kg with renal impairment, severe (creatinine clearance < 30 ml/min/1.73m2): 5-10 mg/kg (0.05-0.10ml/kg) twice daily Pediatric patients and adolescents weighing less than 50kg with renal impairment, end-stage renal disease patients on dialysis (creatinine clearance --): 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. ks= 0.45 (infants under 1 year) ks= 0.55 (children under 13 years and female adolescents) ks= 0.7 (male adolescents) The oral formulation is not recommended for infants under 1 month of age due to insufficient safety and efficacy data. Tablets are not suitable for children 4 years and younger; the oral solution should be administered to infants 1 month and older. The injectable formulation is not recommended for children under 16 years of age because its safety and efficacy have not been established.

This medication may increase the risk of suicidal thoughts or behaviors, so careful monitoring for mood changes or depressive symptoms should be conducted during treatment. This drug may cause central nervous system side effects such as drowsiness, fatigue, coordination disorders, and behavioral abnormalities, especially within the first 4 weeks of administration. Abruptly stopping the medication may worsen seizures, so the dosage should be gradually decreased according to the physician's instructions. It should not be used in individuals with hypersensitivity or allergies to any of its components. Patients with impaired kidney function or severely impaired liver function may need dosage adjustments, so consultation with a doctor is necessary. This medication can cause psychiatric abnormal behaviors such as aggression, anxiety, depression, or suicidal thoughts, so if these symptoms occur, healthcare providers should be notified immediately. Patients with heart disease or electrolyte imbalances are at risk of QT interval prolongation on ECG, so caution is needed. Women who are pregnant or planning to become pregnant must consult with a specialist before taking this medication, and breastfeeding mothers should consider stopping breastfeeding or reevaluating the use of the drug to avoid potential side effects in infants from drug transfer through breast milk. The safety of this medication has not been established in children, particularly infants under 1 month of age, and children under 4 years old should use the liquid formulation instead of tablets. Elderly patients commonly experience reduced kidney function, so the dosage should be carefully determined, and attention is required during the initial administration or dosage increases due to potential drowsiness or dizziness affecting driving or operating machinery. In case of overdose, symptoms such as drowsiness, aggression, and decreased consciousness may appear, and there is no specific antidote, so immediate medical attention should be sought for proper treatment. This medication has few drug interactions, but caution is advised when used in conjunction with methotrexate as blood concentrations may increase. If symptoms of hypersensitivity such as rash, fever, or lymphadenopathy occur during treatment, notify healthcare professionals immediately and discontinue use.

• suicidal thoughts
• suicidal behavior
• depression
• drowsiness
• fatigue
• coordination disorder
• abnormal behavior
• apathy
• psychotic symptoms
• aggression

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is advisable to keep the storage temperature between 1 degree and 30 degrees Celsius at room temperature. Doing so will help maintain the drug's effectiveness for a longer period.

Appearance

Yellow oval film-coated tablet

Package unit

30 tablets/bottle, 120 tablets/bottle