Levirotin 250 mg (Levetiracetam)

Adult dose

The film-coated tablets and oral solution are taken by mouth and may be taken with or without food. Take 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 treatment may be switched directly without dose titration; the total daily dose and frequency of administration should remain the same. Adults and adolescents 16 years and older (monotherapy): The initial dose is 250mg twice daily, increased to 500mg twice daily after 2 weeks. 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]. Adults (18 years and older) and adolescents 12~17 years of age weighing 50kg or more (partial-onset seizures): 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, and the maximum recommended dose is 3000mg/day. 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. Adults (18 years and older) and adolescents 12-17 years of age weighing 50kg or more (primary generalized tonic-clonic seizures): 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. Dose adjustment in adult patients with renal impairment Normal, ≥ 80 (mL/min/1.73m2): 500-1,500mg per dose, twice daily (12-hour intervals) Mild, 50-79 (mL/min/1.73m2): 500-1,000mg per dose, twice daily (12-hour intervals) Moderate, 30-49 (mL/min/1.73m2): 250-750mg per dose, twice daily (12-hour intervals) Severe, < 30 (mL/min/1.73m2): 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 treatment. (2) An additional dose of 250-500mg is recommended after dialysis. 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, when creatinine clearance is less than 60mL/min/1.73m2, it is recommended to reduce the daily maintenance dose by 50%. Elderly patients (65 years and older): Dose adjustment is recommended in elderly patients with impaired renal function.

Child dose

Children 4–11 years of age and adolescents 12–17 years of age weighing less than 50kg (partial-onset seizures): 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 increases or decreases should not exceed 20mg/kg/day [10mg/kg per dose, 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 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 start 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. Adolescents 12-17 years of age weighing less than 50kg (primary generalized tonic-clonic seizures): 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. Dose adjustment in pediatric patients and adolescents weighing less than 50kg with renal impairment Normal, ≥ 80 (ml/min/1.73m2): 10-30mg/kg(0.10-0.30 ml/kg) twice daily Mild, 50-79 (ml/min/1.73m2): 10-20mg/kg(0.10-0.20 ml/kg) twice daily Moderate, 30-49 (ml/min/1.73m2): 5-15mg/kg (0.05-0.15ml/kg) twice daily Severe, < 30 (ml/min/1.73m2): 5-10 mg/kg (0.05-0.10ml/kg) twice daily End-stage renal disease patients on dialysis, --: 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. 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) Infants under 1 month: Oral formulations are not recommended for infants under 1 month because of insufficient safety and efficacy data. Children 4 years of age or younger: Tablets are not applicable to children 4 years of age or younger; infants 1 month and older should receive the oral solution. Children under 16 years: Injection is not recommended for children under 16 years because its safety and efficacy have not been established.

This medication is an antiepileptic drug and carries the risk of mental health issues such as suicidal thoughts, suicidal behavior, and depression during use. Therefore, patients or caregivers must inform the doctor immediately if mood changes or unusual behavior occurs. This medication can cause central nervous system side effects such as drowsiness, fatigue, coordination impairment, and behavioral changes, so caution should be exercised, especially when first taking it or adjusting the dosage. Sudden discontinuation of medication may worsen seizures; therefore, the dosage should be gradually reduced according to the doctor's instructions. Individuals allergic to any of the components of this medication should not take it, and patients with poor kidney or liver function may require dosage adjustment. Blood cell counts may decrease; thus, if symptoms such as fever or weakness appear, a blood test should be performed. Psychiatric symptoms may include irritability, aggression, depression, and anxiety, and if these symptoms worsen, consultation with a physician is necessary. This medication may exacerbate seizure symptoms, so if seizures intensify, medical personnel should be consulted immediately. Patients with heart disease or at risk for QT interval prolongation should be closely monitored for cardiac status. Women who are pregnant or planning to become pregnant should consult their physician regarding the use of this medication, and nursing mothers should determine whether to discontinue breastfeeding or the medication, as it can be passed through breast milk. In children, it should be administered as a liquid form from 1 month of age; safety has not been confirmed in infants under 1 month. Elderly patients may have reduced kidney function, so dosage should be adjusted carefully. Drowsiness or decreased concentration may occur while driving or operating machinery, thus caution is needed. In the case of overdose, symptoms such as decreased consciousness and respiratory depression may occur, and emergency treatment should be sought immediately. There is no specific antidote for this medication. This drug has relatively few interactions with other medications; however, care should be taken as blood levels may increase when used with methotrexate. Lastly, it should be stored out of the reach of children and not transferred to other containers for safety.

• suicidal thoughts
• suicidal behavior
• depression
• drowsiness
• fatigue
• cooperative movement disorder
• abnormal behavior
• weakness
• behavioral disorder
• aggression

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. It is recommended to maintain storage temperature between 1 to 30 degrees Celsius.

Appearance

Blue oval film-coated tablets

Package unit

60 tablets (10 tablets x 6)/PTP