Keppra Extended-Release Tablet 500 mg (Levetiracetam)

Adult dose

Because this medicine is an extended-release tablet, swallow it whole without crushing, splitting, or chewing. This medicine may be taken with or without food, with plenty of water. Take the daily dose once daily. 1. Monotherapy and adjunctive therapy for partial-onset seizures (12 years and older) Adults (18 years and older) Start this medicine 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 Because levetiracetam clearance is related to renal function, administer the dose individually 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 serum creatinine (mg/dl) using the formula below. CLCr(ml/min) = [140 - age (years)] × body weight (kg) (× 0.85: for women) 72×serum creatinine (mg/dl) CLcr is then adjusted according to body surface area (BSA) as follows. CLCr (ml/min/1.73m2) = CLCr(mL/min) × 1.73 body surface area (BSA, m2) Dose adjustment in adults with renal impairment Normal: Creatinine clearance ≧ 80 (mL/min/1.73m2), single dose 1,000-3,000mg, once daily (24-hour interval) Mild: Creatinine clearance 50-79 (mL/min/1.73m2), single dose 1,000-2,000mg, once daily (24-hour interval) Moderate: Creatinine clearance 30-49 (mL/min/1.73m2), single dose 500-1,500mg, once daily (24-hour interval) Severe: Creatinine clearance < 30 (mL/min/1.73m2), single dose 500-1,000mg, once daily (24-hour interval) 3. 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, when creatinine clearance is less than 60mL/min/1.73m2, reducing the daily maintenance dose by 50% is recommended. 4. Older adults (65 years and older) Dose adjustment is recommended in older patients with impaired renal function.

Child dose

Adolescents weighing 50kg or more (12~17 years): Start this medicine 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 during treatment, patients and caregivers should be aware that suicidal thoughts, suicidal behavior, and depressive changes may occur, and should immediately inform healthcare professionals if such symptoms arise. Central nervous system side effects like drowsiness, fatigue, coordination disorders, and behavioral abnormalities may occur at the start of treatment, particularly requiring caution during the first 4 weeks. This medication should not be abruptly discontinued; the dosage should be gradually reduced according to the doctor's advice to prevent worsening of seizures. This drug should not be administered to patients who have allergies to its ingredients or specific genetic disorders such as lactose intolerance. Patients with a history of depression or suicidal thoughts, impaired kidney function, or reduced blood cell count require special caution when using this drug, and should immediately consult a physician if abnormal behavior or worsening seizures occur. In rare cases, QT interval prolongation, a cardiac-related issue, may occur, so patients with heart disease or those taking related medications should be careful. This drug can cause skin rashes or severe skin reactions; if any unusual skin symptoms appear, the medication should be stopped immediately, and healthcare professionals should be consulted. Pregnant or breastfeeding women should consult with a doctor before taking this medication, as it can be transmitted through breast milk and affect the infant. Safety in children or elderly patients has not been firmly established, so patients in these age groups should use it cautiously under a doctor's guidance. This drug may cause drowsiness or dizziness, so it is advisable to avoid dangerous tasks such as driving or operating machinery. In case of overdose, symptoms may include drowsiness, agitation, and decreased consciousness; immediate medical assistance should be sought. This drug has relatively few interactions with other medications, but caution is needed when used in conjunction with specific drugs, so patients should inform healthcare providers of any medications they are taking. This medication should be kept out of the reach of children, and should not be transferred to another container for safety.

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

This medication should be kept in a tightly closed container to avoid exposure to air or moisture. It is recommended to store at room temperature between 1 and 30 degrees Celsius.

Appearance

White oval extended-release film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle