Lepfil 500 mg (Levetiracetam)

Adult dose

Film-coated tablets and oral solution are administered orally and may be taken with or without food, with a sufficient amount of water. The daily dose should be divided into 2 equal doses and administered twice daily. Levetiracetam treatment may be initiated by the intravenous or oral route. When changing 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. Monotherapy and adjunctive therapy for partial-onset seizures: Adults (18 years and older) and adolescents weighing 50kg or more (12~17 years): Treatment with this drug is initiated at 500mg twice daily. However, based on the physician’s assessment of potential adverse reactions relative to seizure reduction, the initial dose may be reduced to 250mg twice daily and increased to 500mg twice daily after 2 weeks. Depending on clinical response and tolerability, the dose may be increased or decreased every 2 to 4 weeks by 500mg/day [250mg per dose, twice daily] or 1000mg/day [500mg per dose, twice daily], up to the maximum recommended dose of 3000mg/day [1500mg per dose, twice daily]. Adjunctive therapy for myoclonic seizures in pediatric patients: Treatment with this drug is initiated at 500mg twice daily. However, based on the physician’s assessment of potential adverse reactions relative to seizure reduction, the initial dose may be reduced to 250mg twice daily and increased to 500mg twice daily after 2 weeks. Depending on clinical response and tolerability, the dose may be increased or decreased every 2 weeks by 500mg/day [250mg per dose, twice daily] or 1000mg/day [500mg per dose, twice daily], up to the maximum recommended dose of 3000mg/day [1500mg per dose, twice daily]. Efficacy at doses below 3,000mg/day has not been studied. Adjunctive therapy for primary generalized tonic-clonic seizures: Adults (18 years and older) and adolescents weighing 50kg or more (12-17 years): Treatment with this drug is initiated at 1,000mg/day [500mg per dose, twice daily]. However, based on the physician’s assessment of potential adverse reactions relative to seizure reduction, the initial dose may be reduced to 250mg twice daily and increased to 500mg twice daily after 2 weeks. Depending on clinical response and tolerability, the dose may be increased or decreased every 2 weeks by 500mg/day [250mg per dose, twice daily] or 1000mg/day [500mg per dose, twice daily], up to the maximum recommended dose of 3000mg/day [1500mg per dose, twice daily]. Efficacy at doses below 3,000mg/day has not been adequately studied. 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. To use the table, the patient’s creatinine clearance (CLCr, mL/min) is required; in adults, it can be calculated from the serum creatinine (mg/dl) level using the formula below. 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 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 recommended that the daily maintenance dose be reduced by 50%. Older adults (65 years and older): Dose adjustment is recommended in elderly patients with impaired renal function.

Child dose

Monotherapy and adjunctive therapy for partial-onset seizures (4 years and older): Children aged 4–11 years and adolescents aged 12–17 years weighing less than 50 kg: The initial dose is 10 mg/kg per dose twice daily. Depending on clinical response and tolerability, the dose may be increased to 60 mg/kg per day [30 mg/kg per dose, twice daily]. Dose adjustments should not exceed an increase or decrease of 20 mg/kg per day [10 mg/kg per dose, twice daily] every 2 weeks. Use the lowest effective dose. The maximum recommended dose is 3000mg per day. For children weighing 20kg or less, it is recommended to initiate treatment with the 100mg/ml oral solution. For children weighing 20~40kg, initiate treatment at 500mg per day [250mg per dose, twice daily]; the dose may be increased by 500mg per day every 2 weeks, up to a maximum of 1500mg per day [750mg per dose, twice daily]. For children weighing more than 40kg, initiate treatment at 1000mg per day [500mg per dose, twice daily]; the dose may be increased by 1000mg per day every 2 weeks, up to a maximum of 3000mg per day [1500mg per dose, twice daily]. The dose for children weighing 50kg or more is the same as the adult dose. Adjunctive therapy for myoclonic seizures in pediatric patients (12 years and older): This medication is initiated at 500mg per dose twice daily. However, based on the physician's assessment of potential adverse reactions relative to seizure reduction, the initial dose may be lowered to 250mg per dose twice daily and increased to 500mg per dose twice daily after 2 weeks. Depending on clinical response and tolerability, the dose may be increased or decreased every 2 weeks by 500mg per day [250mg per dose, twice daily] or 1000mg per day [500mg per dose, twice daily]; the maximum recommended dose is 3000mg per day [1500mg per dose, twice daily]. Efficacy at doses below 3,000mg per day has not been studied. Adjunctive therapy for primary generalized tonic-clonic seizures (12 years and older): Adolescents aged 12-17 years weighing less than 50kg: This medication is initiated at 20mg/kg per day [10mg/kg per dose, twice daily]. The dose is increased by 20mg/kg per 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 at doses below 60mg/kg per day has not been adequately studied. The following formulas are used 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) 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) per dose, 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) per dose, 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) per dose, 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) per dose, 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) per dose, once daily(1)(2) (1) On the first day of treatment, a loading dose of 15 mg/kg(0.15ml/kg) is recommended. (2) After dialysis, an additional dose of 5-10 mg/kg(0.05-0.10ml/kg) is recommended. Children: The oral formulation is not recommended for infants under 1 month of age due to insufficient safety and efficacy data. Tablet administration is not applicable for children 4 years and under; infants 1 month and older should be given the solution. 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 patients should inform medical personnel immediately if they experience mood changes or symptoms of depression during treatment. It can cause central nervous system side effects such as drowsiness, fatigue, coordination issues, and behavioral changes, particularly during the first four weeks when these symptoms may frequently occur. Sudden discontinuation can worsen seizures; therefore, the dosage should be gradually reduced under medical supervision. Patients with an allergy to any component of this medication should not use it, and those with impaired renal function may require dosage adjustments. Blood tests may show decreased white blood cell or platelet counts during treatment, so patients should consult healthcare professionals if symptoms such as weakness, fever, or signs of infection develop. This medication may induce psychiatric abnormalities, including aggression, anxiety, and depression, and any such behavior should be reported to healthcare professionals. Seizures may worsen initially upon starting treatment, so patients should consult their doctor immediately if the frequency of seizures increases. Caution is advised for patients with heart disease or prolonged QT intervals on ECG. Pregnant women or those planning to become pregnant should discuss the use of this medication with their healthcare provider, and nursing mothers should consider discontinuing breastfeeding or the medication, as it may pass into breast milk. For children, safety has not been established in infants under one month, and children under four years should be administered in liquid form. Drowsiness or reduced concentration may occur while driving or operating machinery, so caution is advised. In cases of overdose, symptoms may include drowsiness, agitation, aggression, impaired consciousness, and respiratory depression; in emergencies, it is essential to induce vomiting or perform gastric lavage to remove the drug and obtain necessary treatment. This medication generally has low interaction potential with other drugs, but caution is necessary when taken with methotrexate, as blood concentration may increase. If abnormal symptoms or discomfort occur during treatment, it is vital to consult healthcare professionals immediately.

• suicidal impulses
• suicidal behavior
• depression
• abnormal changes in mood and behavior
• drowsiness
• fatigue
• coordination movement disorder
• behavioral abnormalities
• asthenia
• behavioral disorders

Store this medication in a tightly sealed container to prevent exposure to air or moisture. Additionally, it is safest to keep the medication at room temperature, avoiding extremes of heat or cold, ideally between 1 and 30 degrees Celsius.

Appearance

Yellow oval film-coated tablets

Package unit

30 tablets/bottle, 120 tablets/bottle