Levira Tablet 750 mg (Levetiracetam)

Adult dose

Film-coated tablets and oral solution are administered orally 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. Monotherapy and adjunctive therapy for partial-onset seizures (adults and adolescents aged 18 years and older weighing 50kg or more): The initial dose is 500mg twice daily, which may be reduced to 250mg twice daily at the physician's discretion. After 2 weeks, the dose may be increased to 500mg twice daily. The dose may be increased or decreased every 2 to 4 weeks according to clinical response. The maximum recommended dose is 3000mg per day. Adjunctive therapy for primary generalized tonic-clonic seizures (adults and adolescents aged 18 years and older weighing 50kg or more): The initial dose is 1,000mg per day (500mg twice daily), which may be reduced to 250mg twice daily at the physician's discretion. After 2 weeks, the dose may be increased to 500mg twice daily. The dose may be increased or decreased every 2 weeks according to clinical response. The maximum recommended dose is 3000mg per day. Adjunctive therapy for myoclonic seizures (including children aged 12 years and older): The initial dose is 500mg twice daily, which may be reduced to 250mg twice daily at the physician's discretion. The dose may be increased or decreased every 2 weeks. The maximum recommended dose is 3000mg per day. Dosage adjustment in adults with renal impairment: The individual dose and dosing interval are adjusted according to creatinine clearance. Normal (≥80 mL/min): 500-1,500mg twice daily (12-hour interval) Mild (50-79 mL/min): 500-1,000mg twice daily Moderate (30-49 mL/min): 250-750mg twice daily Severe (<30 mL/min): 250-500mg twice daily End-stage renal disease patients on dialysis: Administer 500-1,000mg once daily; an initial loading dose of 750mg is recommended on the first day, and an additional 250-500mg after dialysis is recommended. Patients with hepatic impairment: No dosage adjustment is necessary in patients with mild to moderate hepatic impairment. In patients with severe hepatic impairment, reduce the daily maintenance dose by 50% if creatinine clearance is less than 60mL/min, because renal impairment may be underestimated. Elderly patients (65 years and older): Dosage adjustment is recommended if renal function is impaired.

Child dose

Monotherapy and adjunctive therapy for partial-onset seizures (children aged 4 to 11 years and adolescents aged 12 to 17 years weighing less than 50kg): The initial dose is 10mg/kg twice daily. The dose may be increased or decreased every 2 weeks according to clinical response, without exceeding 20mg/kg per day; the maximum recommended dose is 3000mg per day. Recommended doses by body weight: - Children weighing 20kg or less: It is recommended to initiate treatment with the 100mg/ml oral solution. - Children weighing 20~40kg: Initial dose of 500mg per day (250mg twice daily); may be increased by 500mg every 2 weeks up to a maximum of 1500mg per day (750mg twice daily). - Children weighing more than 40kg: Initial dose of 1000mg per day (500mg twice daily); may be increased by 1000mg every 2 weeks up to a maximum of 3000mg per day (1500mg twice daily). - Children weighing 50kg or more receive the same dose as adults. Adjunctive therapy for myoclonic seizures (children and adolescents aged 12 years and older): The initial dose is 500mg twice daily, which may be reduced to 250mg twice daily at the physician's discretion. The dose may be increased or decreased every 2 weeks. The maximum recommended dose is 3000mg per day. Adjunctive therapy for primary generalized tonic-clonic seizures (adolescents aged 12 years and older): In adolescents weighing less than 50kg, initiate treatment at 20mg/kg per day (10mg/kg twice daily). Increase by 20mg/kg per day every 2 weeks to the recommended dose of 60mg/kg per day (30mg/kg twice daily). Dosage adjustment in children and adolescents weighing less than 50kg with renal impairment: Adjust the individual dose and dosing regimen according to creatinine clearance. Normal (≥80 mL/min): 10-30mg/kg twice daily Mild (50-79 mL/min): 10-20mg/kg twice daily Moderate (30-49 mL/min): 5-15mg/kg twice daily Severe (<30 mL/min): 5-10mg/kg twice daily End-stage renal disease patients on dialysis: Administer 10-20mg/kg once daily; a loading dose of 15mg/kg is recommended on the first day, and an additional 5-10mg/kg after dialysis is recommended. Dosage adjustment for patients with hepatic impairment and elderly patients is the same as for adults. Other: Oral formulations are not recommended for infants younger than 1 month. Tablets are not appropriate for children aged 4 years or younger; the oral solution should be administered. Administration of the injection to children younger than 16 years is not recommended.

This medication is used for the treatment of epilepsy, and there is a heightened risk of mental health issues such as suicidal thoughts or actions and depression during its use; both patients and caregivers should carefully monitor for the presence of these symptoms. Common central nervous system side effects may occur during the initial phase of treatment, such as drowsiness, fatigue, coordination dysfunction, and behavioral changes, especially in children and patients aged 6 and older where behavioral disorders are reported more frequently. Abrupt discontinuation of this medication may worsen seizures, so dosage should be gradually reduced under physician guidance when stopping treatment. Patients with allergies to this medication or its components should not take it, and those with kidney or liver function issues may require dose adjustments. This medication contains yellow coloring which should be used with caution in patients allergic to this component. Blood-related adverse effects such as decreased blood cell counts may occur, so patients should promptly inform healthcare providers if they experience fatigue, fever, or symptoms of infection. Psychiatric symptoms may include irritability, aggression, depression, anxiety, hallucinations, and behavioral changes; consultation with a physician may be necessary for medication adjustment if such changes are observed. Seizures may worsen during treatment with this medication, so any exacerbation of seizures or emergence of new symptoms should prompt immediate consultation with healthcare providers. Patients with heart disease or those at risk for QT interval prolongation must be closely monitored with electrocardiograms. This medication does not exhibit significant drug interactions with other antiepileptic drugs or oral contraceptives, digoxin, and warfarin; however, monitoring of blood concentration is necessary when administered with methotrexate. The safety of this medication during pregnancy has not been fully established regarding its effects on the fetus, thus women planning pregnancy or currently pregnant should consult with their physician. During breastfeeding, the medication can pass into milk potentially affecting the baby, necessitating consideration of either discontinuing breastfeeding or stopping the medication. It can be used in children and the elderly, but particularly in older adults with compromised kidney function, dose adjustments may be necessary. Caution is advised as drowsiness or loss of concentration may occur when driving or operating machinery, and overdose may cause altered consciousness and respiratory depression, requiring immediate emergency attention. This medication should be stored safely out of the reach of children, and transferring it to another container is not recommended for quality preservation and safety purposes.

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

This medication should be stored in a tightly closed container to prevent air or moisture, and it is recommended to keep it at room temperature between 1 to 30 degrees Celsius. This will maintain the medication's effectiveness and prevent degradation.

Appearance

Orange oval film-coated tablet

Package unit

60 tablets/box [10 tablets/PTPX6]