Leviqur Tablets 1000 mg (Levetiracetam)

Adult dose

Film-coated tablets and oral solution are administered orally, with or without food, and should be taken with plenty of water. The total 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 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 16 years and older: Treatment is initiated at 250mg twice daily and increased to 500mg twice daily after 2 weeks. Depending on clinical response, the dose may be increased every 2 weeks by 500mg/day [250mg per dose, twice daily], up to a maximum dose of 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): Treatment with 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/day [500mg per dose, twice daily], up to the maximum recommended dose of 3000mg/day. Adjunctive therapy — Primary generalized tonic-clonic seizures, adults (18 years and older) and adolescents weighing 50kg or more (12-17 years): Treatment with this medicine 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 has not been adequately studied at doses below 3,000mg/day. Patients with renal impairment: Since levetiracetam clearance is related to renal function, the dose should be individualized according to the patient’s renal function. Refer to the table below for dose adjustment in adults. Adult patients with renal impairment — Normal, creatinine clearance ≥ 80 (mL/min/1.73m2): 500-1,500mg per dose, twice daily (12-hour intervals) Adult patients with renal impairment — Mild, creatinine clearance 50-79 (mL/min/1.73m2): 500-1,000mg per dose, twice daily (12-hour intervals) Adult patients with renal impairment — Moderate, creatinine clearance 30-49 (mL/min/1.73m2): 250-750mg per dose, twice daily (12-hour intervals) Adult patients with renal impairment — Severe, creatinine clearance < 30 (mL/min/1.73m2): 250-500mg per dose, twice daily (12-hour intervals) Adult patients with renal impairment — 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 impairment. Therefore, if creatinine clearance is less than 60mL/min/1.73m2, it is recommended that the daily maintenance dose be reduced by 50%. Elderly patients (65 years and older): Dose adjustment is recommended in elderly patients with impaired renal function.

Child dose

Adjunctive therapy — partial-onset seizures, children aged 4-11 years and adolescents aged 12-17 years weighing less than 50kg: The initial dose is 10mg/kg per dose 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 adjustments should not exceed increases or decreases of 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. 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] 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] 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. (2) The dosage and administration for children and adolescents weighing 50kg or more are the same as for adults. Adjunctive therapy — myoclonic seizures in pediatric patients (12 years and older): This medicine is initiated at 500mg per dose twice daily. The dose is increased by 1,000mg/day every 2 weeks up 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, adolescents aged 12-17 years weighing less than 50kg: This medicine 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 has not been adequately studied at doses below 60mg/kg/day. ks= 0.45 (infants under 1 year) ks= 0.55 (children under 13 years and adolescent females) ks= 0.7 (adolescent males) 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 requiring 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. Oral formulations are not recommended for infants younger than 1 month because of insufficient safety and efficacy data. Tablet administration is not applicable in children 4 years and younger; the oral solution should be administered to infants aged 1 month and older. Administration of the injection is not recommended in children younger than 16 years, as its safety and efficacy have not been established.

This drug is used to treat epilepsy and poses a risk of changes in mental health, including suicidal thoughts or behavior and depression during treatment. Therefore, patients and caregivers should notify medical personnel immediately of any mood or behavioral changes. This drug may cause neuropsychiatric side effects, such as drowsiness, fatigue, coordination problems, and behavioral changes, particularly in the first four weeks of treatment. Abruptly stopping this medication can worsen seizures, so the dosage should be reduced gradually according to the doctor's instructions. This drug should not be used by individuals who have allergies or hypersensitivity to any of its ingredients. Patients with impaired kidney function may require dosage adjustments, and renal function testing is recommended in cases of severe liver dysfunction. Additionally, blood cell counts may decrease, so blood tests may be necessary if symptoms like fever or fatigue occur. This drug may also induce behavioral changes such as irritability and aggression; consultation with healthcare providers is necessary if such psychiatric symptoms appear. Seizures may worsen during the initial dosing or with increases in dosage, so caution is needed. Patients with heart disease or those with prolonged QT intervals on electrocardiograms require special monitoring. The effects of this drug on the fetus during pregnancy are not fully understood, so careful use is required, and during breastfeeding, the medication may transfer through breast milk, affecting the baby, necessitating either discontinuation of breastfeeding or reconsideration of drug use. Caution is advised when driving or operating machinery, as drowsiness or decreased concentration may occur. In cases of overdose, symptoms such as drowsiness, aggression, and decreased consciousness may present; there is no specific antidote, so proper treatment should be sought immediately at a hospital. This medication interacts minimally with other drugs, but when used concurrently with methotrexate, blood concentration monitoring is necessary. Careful use is required when administering to children or elderly patients, considering dosage and physical condition. Finally, it is important to store this medication out of reach of children and not transfer it to other containers.

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

Store this medication tightly closed in a container to protect it from air and moisture. It is best to maintain a storage temperature at room temperature between 1-30 degrees Celsius.

Appearance

White oval film-coated tablet

Package unit

30 tablets/bottle, 60 tablets/bottle