Keppra Extended Release Tablet 750 mg (Levetiracetam)

Adult dose

This is an extended-release tablet. Take it whole without crushing, splitting, or chewing. This medicine may be taken with or without food, with plenty of water. Take the total daily dose once daily. 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 once daily. Patients with renal impairment Because levetiracetam clearance is related to renal function, the dose should be individualized 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, this can be calculated from the serum creatinine (mg/dl) using the following formula. CLCr(ml/min) = [140 - age (years)] × body weight (kg) (× 0.85: for women) 72×serum creatinine (mg/dl) CLcr is then adjusted for 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 1,000-3,000mg, once daily (24-hour interval) Mild: Creatinine clearance 50-79 mL/min/1.73m2, dose per administration 1,000-2,000mg, once daily (24-hour interval) Moderate: Creatinine clearance 30-49 mL/min/1.73m2, dose per administration 500-1,500mg, once daily (24-hour interval) Severe: Creatinine clearance < 30 mL/min/1.73m2, dose per administration 500-1,000mg, once daily (24-hour interval) Patients with hepatic impairment No dose adjustment is needed 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, it is recommended that the daily maintenance dose be reduced by 50%. Older adults (65 years and older) Dose adjustment is recommended in older patients with reduced renal function.

Child dose

Monotherapy and adjunctive therapy for partial-onset seizures (12 years and older) 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 once daily.

This medication is used for the treatment of epilepsy, and there may be an increased risk of suicidal thoughts or behaviors, and mental health issues such as depression during treatment. Therefore, patients and caregivers should inform healthcare providers immediately about any mood changes or unusual behaviors. During treatment, central nervous system side effects such as drowsiness, fatigue, impaired coordination, and behavioral changes may occur, so caution is required. Additionally, discontinuation of this medication abruptly may lead to more frequent seizures, thus dosage must be gradually reduced. Patients with allergic reactions or specific genetic lactose breakdown disorders should not take this medication. Patients with impaired kidney function may require dosage adjustments, and patients with severely impaired liver function should undergo kidney function testing first. Serious side effects such as decreased blood cell counts or severe skin reactions can occur, so immediate consultation with a physician is necessary if symptoms like rash, fever, or malaise appear. This medication may affect the fetus when used during pregnancy, so women who are planning to conceive or are pregnant must consult a physician. During breastfeeding, this medication may be excreted in breast milk and affect the baby, so careful consideration regarding breastfeeding is necessary. Caution should be taken when driving or operating machinery due to possible drowsiness or decreased concentration. In case of overdose, symptoms such as altered consciousness or respiratory depression may occur, requiring immediate emergency treatment. Although the potential for drug interactions during the use of this medication is low, it is advisable to consult a physician when used in combination with specific medications. Special caution is required for children or the elderly as the safety and efficacy of this medication have not been sufficiently established. This medication should be kept out of the reach of children, and transferring it to another container should be avoided as it may pose a risk of accidents and quality degradation.

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

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is advisable to maintain storage temperatures between 1 to 30 degrees Celsius at room temperature. Proper storage will help to preserve the medication's efficacy and safety for an extended period.

Appearance

White oval extended-release film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle