Epileptam Sustained-release Tablets 750 mg (Levetiracetam)

Adult dose

Because this is an extended-release tablet, swallow it whole without crushing, splitting, or chewing. This medicine may be taken with or without food. Take it with plenty of water. Take the total daily dose once daily. 1. Monotherapy and adjunctive therapy for partial-onset seizures (12 years and older) Adults (18 years and older) Start treatment with 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 daily. 2. Patients with renal impairment Refer to the table below for dose adjustment in adults. Normal (creatinine clearance ≧ 80 mL/min/1.73m2): Single dose 1,000-3,000mg, once daily (24-hour intervals) Mild (creatinine clearance 50-79 mL/min/1.73m2): Single dose 1,000-2,000mg, once daily (24-hour intervals) Moderate (creatinine clearance 30-49 mL/min/1.73m2): Single dose 500-1,500mg, once daily (24-hour intervals) Severe (creatinine clearance < 30 mL/min/1.73m2): Single dose 500-1,000mg, once daily (24-hour intervals) 3. Patients with hepatic impairment No dose adjustment is needed in patients with mild to moderate hepatic impairment. For patients with severe hepatic impairment, it is recommended that the daily maintenance dose be reduced by 50% if creatinine clearance is less than 60mL/min/1.73m2. 4. Older adults (65 years and older) Dose adjustment is recommended in older patients with reduced renal function.

Child dose

12 years and older: Adolescents weighing 50kg or more (12~17 years). Start treatment with 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 daily.

This medication is used for the treatment of epilepsy, and during its use, suicidal thoughts, behaviors, and mental health issues such as depression can arise, hence careful observation is required. Upon initial use or dosage adjustment, neurological symptoms such as drowsiness, fatigue, coordination disorders, and behavioral abnormalities may occur; thus, if these symptoms appear, consultation with a healthcare professional is necessary. Abruptly stopping the medication may worsen seizures, therefore, gradual dosage reduction must be followed as per healthcare professional's instructions. If there is hypersensitivity to this medication or an allergy to the active ingredient, it should not be taken. If suicidal thoughts or symptoms of depression occur, inform healthcare professionals immediately, and dosage adjustments may be necessary for patients with impaired renal function. Because decreases in blood cell counts or severe skin reactions (e.g., Stevens-Johnson syndrome) may occur, if symptoms such as rash, fever, or weakness appear, notify healthcare professionals immediately. This medication may affect the ability to drive or operate machinery, so caution should be exercised at the beginning of treatment or when increasing the dosage. Women who are pregnant or planning to become pregnant should consult healthcare professionals about taking this medication, and breastfeeding mothers should consider stopping breastfeeding or reevaluating the use of the medication, as it can pass into breast milk. Safety in children, particularly those under 12 years of age and the elderly, has not been sufficiently established; therefore, this medication should be used cautiously. Drug interactions are relatively few; however, taking certain medications together may cause changes in blood concentrations, so it is important to inform healthcare professionals of any current medications. In the case of overdose, symptoms such as drowsiness, aggressiveness, and impaired consciousness may occur, and immediate emergency treatment is required. This medication should be kept out of the reach of children, and it is advisable not to transfer it to another container.

• suicidal ideation
• suicidal behavior
• depression
• abnormal changes in mood and behavior
• drowsiness
• fatigue
• coordination motor disturbance
• behavioral abnormalities
• asthenia
• irritability

This medication should be stored in a tightly closed container to avoid exposure to air or moisture. The recommended storage temperature is room temperature between 1 and 30 degrees Celsius. This helps maintain the medication's efficacy and allows for safe use.

Appearance

White oval sustained-release film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle