Levira Tablet 1000 mg (Levetiracetam)

Adult dose

Film-coated tablets and oral solution are administered orally and may be taken with or without food, 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 from oral to intravenous administration or vice versa, the route of administration may be changed 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 of age and older) and adolescents weighing 50kg or more (12~17 years) Start this medicine at 500mg 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 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 primary generalized tonic-clonic seizures: Adults (18 years of age and older) and adolescents weighing 50kg or more (12-17 years) Start this medicine 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 lowered 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 has not been adequately studied at doses below 3,000mg/day. Patients with renal impairment: Since 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 in 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 administration. (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%. Older adults (65 years of age and older): Dose adjustment is recommended in older patients with reduced renal function.

Child dose

Monotherapy and adjunctive therapy for partial-onset seizures (4 years of age and older): Children aged 4~11 years and adolescents aged 12~17 years weighing less than 50kg: Start with 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 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. The maximum recommended dose is 3000mg/day. Children weighing 20kg or less: It is recommended to initiate treatment with the 100mg/ml oral solution. Children weighing 20~40kg: Start with 500mg/day [250mg per dose, twice daily] and increase by 500mg/day every 2 weeks, up to a maximum of 1500mg/day [750mg per dose, twice daily]. Children weighing more than 40kg: Start with 1000mg/day [500mg per dose, twice daily] and increase by 1000mg/day every 2 weeks, up to a maximum of 3000mg/day [1500mg per dose, twice daily]. Children weighing 50kg or more: 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 of age and older): Start this medicine 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 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 has not been studied at doses below 3,000mg/day. Adjunctive therapy for primary generalized tonic-clonic seizures (12 years of age and older): Adolescents aged 12-17 years weighing less than 50kg: Start this medicine 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. Patients with renal impairment: Use the following formulas for infants, children, and adolescents. ks= 0.45 (infants under 1 year of age) ks= 0.55 (children under 13 years of age and female adolescents) ks= 0.7 (male adolescents) Dose adjustment in 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 Mild, creatinine clearance 50-79 (ml/min/1.73m2): 10-20mg/kg (0.10-0.20 ml/kg) per dose, twice daily Moderate, creatinine clearance 30-49 (ml/min/1.73m2): 5-15mg/kg (0.05-0.15ml/kg) per dose, twice daily Severe, creatinine clearance < 30 (ml/min/1.73m2): 5-10 mg/kg (0.05-0.10ml/kg) per dose, twice daily 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) A loading dose of 15 mg/kg (0.15ml/kg) is recommended on the first day of administration. (2) An additional dose of 5-10 mg/kg (0.05-0.10ml/kg) is recommended after dialysis. Children: The oral dosage form is not recommended for infants under 1 month of age due to insufficient safety and efficacy data. Tablets are not suitable for children under 4 years of age; the oral solution should be administered to infants 1 month of age and older. Injection is not recommended in children under 16 years of age because safety and efficacy have not been established.

This medication is used for the treatment of epilepsy. During treatment, changes in mental health, such as suicidal thoughts or behaviors and depression, may occur, and careful observation is required. In particular, such symptoms may appear early in treatment, so patients and caregivers should immediately inform the healthcare provider if they notice any symptoms. This medication can cause central nervous system side effects such as drowsiness, fatigue, coordination difficulties, and behavioral abnormalities, which often occur within the first 4 weeks of treatment. Some children over the age of 6 may exhibit behavioral disturbances. Abruptly discontinuing the medication may worsen seizures, so the dosage should be gradually reduced according to the physician's instructions. Patients allergic to this medication or any of its components should not take it. Patients with poor renal function may require dosage adjustments, and if liver function is severely impaired, renal function testing is recommended before administration. Since side effects may include a decrease in blood cell count, blood tests should be conducted if symptoms such as fatigue, fever, or signs of infection occur. There may be psychiatric symptoms or behavioral changes such as aggression and irritability; therefore, consultation with a physician is required if these symptoms occur. Seizures may worsen, so consult with healthcare providers if symptoms deteriorate. Patients with heart disease or electrolyte imbalances may need monitoring for abnormal electrocardiograms. Use of this medication during pregnancy can affect the fetus, so women who are pregnant or planning to become pregnant must consult with their healthcare provider. During breastfeeding, this medication may be excreted in breast milk and affect the infant, so careful consideration is necessary regarding lactation and medication use. Safety for children, especially infants under 1 month of age, has not been established, and children under 4 years should use a liquid formulation instead of tablets. Older adults may have a higher risk of side effects due to decreased kidney function, so dosage adjustments are necessary. This medicine may cause drowsiness or decreased concentration, so care should be taken when driving or operating machinery. In case of overdose, immediate medical attention is needed, and there is no specific antidote. This medication generally has low drug interactions when used with other antiepileptic drugs or oral contraceptives; however, caution should be exercised as it may change blood concentration levels with certain medications. It is essential to consult with healthcare providers for any adverse reactions during the use of this medication for appropriate measures.

• suicidal thoughts
• suicidal behavior
• depression
• abnormal changes in mood and behavior
• drowsiness
• fatigue
• coordination disorders
• behavioral abnormalities
• weakness
• psychotic symptoms

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is best to maintain a storage temperature between 1 degree and 30 degrees Celsius. This ensures the efficacy of the medication remains effective for a longer period.

Appearance

White oval film-coated tablet

Package unit

60 tablets/box [10 tablets/PTPX6]