Keppra XR Extended-Release Tablet 750 mg (Levetiracetam)

Adult dose

As this medicine is an extended-release tablet, swallow it whole without crushing, splitting, or chewing. This medicine may be taken regardless of meals 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) Initiate treatment with this medicine at 1,000 mg once daily. Depending on clinical response and tolerability, the dose may be increased or decreased by 1,000 mg once daily every 2 weeks; the maximum recommended dose is 3,000 mg daily. 2. Patients with renal impairment Because levetiracetam clearance is related to renal function, administer 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 the serum creatinine level (mg/dL) using the formula below. CLCr (mL/min) = [140 - age (years)] × body weight (kg) (× 0.85 for women) 72 × serum creatinine (mg/dL) Then, adjust CLcr 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 adult patients with renal impairment Normal, creatinine clearance ≧ 80 (mL/min/1.73m2): dose per administration 1,000-3,000 mg, once daily (24-hour interval) Mild, creatinine clearance 50-79 (mL/min/1.73m2): dose per administration 1,000-2,000 mg, once daily (24-hour interval) Moderate, creatinine clearance 30-49 (mL/min/1.73m2): dose per administration 500-1,500 mg, once daily (24-hour interval) Severe, creatinine clearance < 30 (mL/min/1.73m2): dose per administration 500-1,000 mg, 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 failure. Therefore, if creatinine clearance is less than 60mL/min/1.73m2, it is recommended to reduce the daily maintenance dose by 50%. 4. Older adults (65 years and older) Dose adjustment is recommended in older patients with reduced renal function.

Child dose

1. Monotherapy and adjunctive therapy for partial-onset seizures (12 years and older): Adolescents (12~17 years) weighing 50 kg or more should initiate treatment with this medicine at 1,000 mg once daily. Depending on clinical response and tolerability, the dose may be increased or decreased by 1,000 mg once daily every 2 weeks; the maximum recommended dose is 3,000 mg daily.

This drug may increase the risk of suicidal thoughts or behaviors, so it is important to closely monitor for mood changes or symptoms of depression during treatment. It may affect the central nervous system, causing symptoms such as drowsiness, fatigue, coordination disturbances, and behavioral abnormalities, especially within the first 4 weeks of treatment. Abrupt discontinuation of the medication may worsen seizures, therefore the dosage should be gradually reduced according to the physician's instructions. Patients with allergies to any of the components in this medication should not take it, and dose adjustments may be needed for patients with impaired renal function. There have been reports of decreased blood cell counts, so if severe fatigue, fever, or recurrent infection symptoms occur, a blood test should be conducted. Psychiatric symptoms such as irritability, aggression, anxiety, depression, hallucinations may occur, and if these symptoms appear, immediate consultation with a medical professional is necessary. Careful monitoring is advised, as seizures may worsen when starting the medication or increasing the dosage. Cardiovascular side effects such as QT interval prolongation on the electrocardiogram may occur, requiring caution in patients with heart conditions or those taking related medications. Pregnant or lactating women should consult a physician before taking this drug, especially since the medication may pass into breast milk and affect the infant, thus requiring careful consideration. Safety and effectiveness are not sufficiently established for children and the elderly, so caution is advised. Those engaging in tasks requiring concentration, such as driving or operating machinery, should be aware that symptoms such as drowsiness or dizziness may occur. In cases of overdose, symptoms such as drowsiness, aggression, or decreased consciousness may present, and appropriate treatment should be administered by a medical institution immediately. This drug has relatively low interaction with other medications, but caution should be observed when used in conjunction with specific drugs, so inform healthcare providers of any other medications being taken. If any adverse reactions such as skin rashes or severe allergic reactions occur, immediately discontinue the medication and consult healthcare professionals.

• suicidal impulses
• suicidal behavior
• depression
• abnormal changes in mood and behavior
• drowsiness
• fatigue
• cooperative movement disorder
• behavioral abnormalities
• asthenia
• irritability

This medicine is sensitive to air and moisture, so it must be stored in a tightly closed container. Additionally, avoid storing in extreme hot or cold conditions, and keep it at room temperature between 1 and 30 degrees Celsius.

Appearance

White, rectangular, extended-release film-coated tablet

Package unit

30 tablets/box [10 tablets/PTP×3]