Epilatam Extended Release 500 mg (Levetiracetam)

Adult dose

This drug is an extended-release tablet; swallow it whole without crushing, splitting, or chewing. This drug may be administered with or without food and should be taken with plenty of water. The daily dose is taken once daily. 1. Monotherapy and adjunctive therapy for partial-onset seizures (12 years and older) Adults (18 years and older) Treatment with this drug is initiated at 1,000mg once daily. Depending on clinical response and tolerability, the dose may be increased or decreased by 1,000mg once daily every 2 weeks. The maximum recommended dose is 3,000mg per day. 2. Patients with renal impairment Since levetiracetam clearance is related to renal function, dosage should be individualized according to the patient's renal function. See the table below for dose adjustment in adults. Dose adjustment in adult patients with renal impairment Normal (creatinine clearance ≧ 80 mL/min/1.73m2): 1,000-3,000mg per dose, once daily (24-hour interval) Mild (creatinine clearance 50-79 mL/min/1.73m2): 1,000-2,000mg per dose, once daily (24-hour interval) Moderate (creatinine clearance 30-49 mL/min/1.73m2): 500-1,500mg per dose, once daily (24-hour interval) Severe (creatinine clearance < 30 mL/min/1.73m2): 500-1,000mg per dose, once daily (24-hour interval) 3. 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, reducing the daily maintenance dose by 50% is recommended. 4. Elderly patients (65 years and older) Dose adjustment is recommended in elderly patients with reduced renal function.

Child dose

Adolescents weighing 50kg or more (12~17 years): Treatment with this drug is initiated at 1,000mg once daily. Depending on clinical response and tolerability, the dose may be increased or decreased by 1,000mg once daily every 2 weeks. The maximum recommended dose is 3,000mg per day.

This medication is used for the treatment of epilepsy and may increase the risk of suicidal thoughts or behaviors; therefore, any changes in mood or abnormal behavior during treatment must be reported to healthcare professionals immediately. During initial use or dosage adjustments, neurological or psychiatric adverse effects such as drowsiness, fatigue, coordination disturbances, and behavioral changes may occur, so caution is warranted. Abrupt discontinuation of the medication may exacerbate seizures; thus, it must be discontinued gradually under the guidance of healthcare professionals. Do not use this medication if there is an allergic reaction or hypersensitivity to any of its components. If there are any thoughts of suicide or symptoms of depression, notify healthcare professionals right away. Patients with impaired kidney or liver function may require dosage adjustments. A blood test should be conducted to check for decreased blood cell counts, and if psychiatric symptoms such as behavioral changes or aggression occur, consultation with healthcare professionals is necessary. During initial dosing, seizures may worsen, so immediate medical attention should be sought if any abnormal symptoms arise. Patients with heart-related diseases or at risk for QT interval prolongation should be monitored closely with ECG. This medication may cause severe skin reactions, such as Stevens-Johnson syndrome or toxic epidermal necrolysis; thus, it should be discontinued immediately if any skin rash or abnormal symptoms occur. Pregnant or breastfeeding individuals should consult with healthcare professionals before taking this medication, especially since the drug can be excreted in breast milk and affect the baby. When performing tasks that require concentration, such as driving or operating machinery, drowsiness or dizziness may occur, so caution is advised. In case of overdose, immediate emergency treatment is required, and while there is no specific antidote, symptomatic treatment and dialysis may be necessary. Children, the elderly, and patients with impaired kidney function require special attention regarding dosage adjustments and usage. This medication has few drug interactions; however, caution is necessary when used in combination with certain medications, so individuals should inform healthcare professionals of any concurrent medications.

• Suicidal ideation
• suicidal behavior
• depression
• abnormal changes in mood and behavior
• drowsiness
• fatigue
• coordination movement disorders
• behavioral abnormalities
• weakness
• irritability

This medication should be stored in a tightly closed container to avoid exposure to air or moisture. It is important to maintain the storage temperature between 1 to 30 degrees Celsius to preserve its effectiveness.

Appearance

White oval-shaped extended release film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle