Levetiracetam Tablet 1000 mg (Levetiracetam)

Adult dose

Film-coated tablets and solution are administered orally and may be taken with or without food, with plenty of water. The daily dose should be divided into 2 equal doses. Levetiracetam treatment may be initiated by intravenous or oral administration. When switching from oral to intravenous administration or vice versa, the change may be made directly without dose titration; the total daily dose and frequency of administration should remain the same. Monotherapy - Adults and adolescents 16 years and older: The initial dose is 250mg twice daily, increased after 2 weeks to 500mg twice daily. Depending on clinical response, the dose may be increased by 500mg/day [250mg per dose, twice daily] every 2 weeks; the maximum dose is 3000mg/day [1500mg per dose, twice daily]. Adjunctive therapy - Partial-onset seizures, adults (18 years and older): Start treatment with 500mg per dose twice daily. Depending on clinical response and tolerability, the dose may be increased or decreased by 1000mg/day [500mg per dose, twice daily] every 2 to 4 weeks; the maximum recommended dose is 3000mg/day. Patients with renal impairment: Refer to the table below for dose adjustment in adults. Adult patients with renal impairment - Normal, creatinine clearance ≥ 80 mL/min/1.73m2: 500-1,500mg per dose, twice daily (12-hour interval) Mild, 50-79 mL/min/1.73m2: 500-1,000mg per dose, twice daily (12-hour interval) Moderate, 30-49 mL/min/1.73m2: 250-750mg per dose, twice daily (12-hour interval) Severe, < 30 mL/min/1.73m2: 250-500mg per dose, twice daily (12-hour interval) End-stage renal disease patients on dialysis (1), creatinine clearance -: 500-1,000mg per dose, once daily (2) (1) An initial loading dose of 750mg is recommended on the first day of administration. (2) An additional dose of 250-500mg is recommended after dialysis. 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, if creatinine clearance is less than 60mL/min/1.73m2, it is recommended that the daily maintenance dose be reduced by 50%. Elderly patients (65 years and older): Dose adjustment is recommended in elderly patients with reduced renal function.

Child dose

Adjunctive therapy - partial-onset seizures, adolescents (12-17 years) weighing 50kg or more: Start this medication at 500mg twice daily. Depending on clinical response and tolerability, the dose may be increased or decreased by 1000mg/day [500mg twice daily] every 2 to 4 weeks; the maximum recommended dose is 3000mg/day. Adjunctive therapy - partial-onset seizures, children aged 4 to 11 years and adolescents aged 12 to 17 years weighing less than 50kg: The initial dose is 10mg/kg twice daily. Depending on clinical response and tolerability, the dose may be increased up to 60mg/kg/day [30mg/kg twice daily]; dose changes should not exceed 20mg/kg/day [10mg/kg twice daily] increases or decreases every 2 weeks. Use the lowest effective dose. The dose for children weighing 50kg or more is the same as the adult dose. 15-20kg(1): 20mg/kg/day (twice daily) 300mg-400mg/day [150-200mg twice daily]; 40mg/kg/day (twice daily) 600mg-800mg/day [300-400mg twice daily]; 60mg/kg/day (twice daily) 900mg-1,200mg/day [450-600mg twice daily] 20.1-40kg: 20mg/kg/day (twice daily) 500mg/day [250mg twice daily]; 40mg/kg/day (twice daily) 1,000mg/day [500mg twice daily]; 60mg/kg/day (twice daily) 1,500mg/day [750mg twice daily] 40.1-50kg(2): 20mg/kg/day (twice daily) 1,000mg/day [500mg twice daily]; 40mg/kg/day (twice daily) 2,000mg/day [1,000mg twice daily]; 60mg/kg/day (twice daily) 3,000mg/day [1,500mg twice daily] (1) For children weighing 20kg or less, it is recommended to initiate treatment with the 100mg/mL oral solution. (2) The dosage and administration for children and adolescents weighing 50kg or more are the same as for adults. Myoclonic seizures in pediatric patients (12 years and older): Start this medication at 500mg twice daily. Increase the dose by 1,000mg/day every 2 weeks up to the recommended daily dose of 3,000mg. Efficacy at doses below 3,000mg/day has not been studied. Primary generalized tonic-clonic seizures (12 years and older), adolescents (12-17 years) weighing 50kg or more: Start this medication at 1,000mg/day [500mg twice daily]. Increase the dose by 1,000mg/day [500mg twice daily] every 2 weeks up to the recommended daily dose of 3,000mg [1,500mg twice daily]. Efficacy at doses below 3,000mg/day has not been adequately studied. Primary generalized tonic-clonic seizures (12 years and older), adolescents aged 12-17 years weighing less than 50kg: Start this medication at 20mg/kg/day [10mg/kg twice daily]. Increase the dose by 20mg/kg/day [10mg/kg twice daily] every 2 weeks up to the recommended daily dose of 60mg/kg [30mg/kg twice daily]. Efficacy at doses below 60mg/kg/day has not been adequately studied. Formula for renal function in infants, children, and adolescents: ks= 0.45 (infants under 1 year); ks= 0.55 (children and female adolescents under 13 years); ks= 0.7 (male adolescents) Pediatric patients and adolescents weighing less than 50kg with renal impairment - Normal, creatinine clearance ≥ 80 (ml/min/1.73m2): 10-30mg/kg(0.10-0.30 ml/kg) twice daily Mild, 50-79 (ml/min/1.73m2): 10-20mg/kg(0.10-0.20 ml/kg) twice daily Moderate, 30-49 (ml/min/1.73m2): 5-15mg/kg (0.05-0.15ml/kg) twice daily Severe, < 30 (ml/min/1.73m2): 5-10 mg/kg (0.05-0.10ml/kg) twice daily End-stage renal disease patients on dialysis, creatinine clearance --: 10-20mg/kg(0.10-0.20 ml/kg) once daily(1)(2) (1) A loading dose of 15 mg/kg(0.15ml/kg) is recommended on the first day of treatment. (2) An additional dose of 5-10 mg/kg(0.05-0.10ml/kg) is recommended after dialysis. The oral formulation is not recommended for infants under 1 month of age because of insufficient safety and efficacy data. Tablet administration is not applicable for children 4 years of age or younger; infants 1 month of age and older should receive the oral solution. The injection is not recommended for children under 16 years of age because its safety and efficacy have not been established.

This medication is used in the treatment of epilepsy and may increase the risk of suicidal thoughts or behaviors, so changes in mental state should be observed closely during treatment. Central nervous system adverse reactions such as drowsiness, fatigue, motor coordination impairment, and behavioral changes can commonly occur within the first 4 weeks of treatment initiation. Abruptly stopping the medication may exacerbate seizures, so doses should be reduced gradually according to the physician's instructions. If there are allergies to this medication or similar drugs, it should not be taken. Patients with depression or suicidal thoughts should consult with their physician, and dosage adjustments may be necessary for patients with impaired kidney function. Since a decrease in blood cell counts may occur, blood tests are recommended if fever or symptoms of infection arise. This medication may cause behavioral changes such as irritability and aggressiveness or psychiatric symptoms; thus, any abnormal behaviors should be reported to the physician. Seizures may worsen at the start of treatment or when the dose increases, so immediate consultation with healthcare professionals is needed upon symptom emergence. Patients with heart diseases or risks of QT interval prolongation should use caution during administration. Drowsiness or dizziness may occur during treatment, necessitating caution when driving or operating machinery. Pregnant or breastfeeding women should decide on the use of this medication after consulting with a physician, particularly during breastfeeding as the drug may be transmitted through breast milk. In children, the liquid form is administered starting at over one month of age, and tablet use is not recommended for infants younger than one month or children aged four and younger. Elderly patients may have an increased risk of side effects due to decreased renal function and may require dosage adjustments. In cases of overdose, the medication may be removed through vomiting or gastric lavage; if necessary, blood dialysis may be performed. This medication has relatively fewer interactions when taken with other anti-epileptics or oral contraceptives, but caution is advised regarding changes in blood concentration when used with methotrexate. If adverse reactions such as rash, fever, or lymphadenopathy occur, immediate notification to healthcare professionals is required, and in severe cases, discontinuation of the drug may be necessary. This medication has been commonly reported to cause drowsiness, fatigue, behavioral changes, headaches, dizziness, and other side effects in both children and adults, which may impact daily activities.

suicidal thoughts, suicidal behavior, depression, abnormal changes in mood and behavior, drowsiness, fatigue, coordination movement disorder, behavioral abnormalities, asthenia, behavioral disorders, aggression, anxiety, anger, emotional blunting, depersonalization, emotional instability, hostility, psychotic symptoms, hallucinations, psychotic depression, aggressiveness, suicide attempts, suicidal ideation, excitability, abnormal behavior, behavioral disorders, anger, apathy, mood changes, mood swings, rejection, delusional behavior, encephalopathy, neuroleptic malignant syndrome, prolonged QT interval on ECG, chorea, dyskinesia, sensory disturbances, hypersomnia, gait disorders, exacerbation of seizures, psychotic disorders, abnormal behavior, delirium, panic attacks, anger, delirium, obsessive-compulsive disorder, pancreatitis, liver failure, hepatitis, liver function test abnormalities, weight loss, hyponatremia, toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, hair loss, muscle weakness, pancytopenia, agranulocytosis, leukopenia, neutropenia, drug reactions with eosinophilia and systemic symptoms, hypersensitivity reactions, angioedema, anaphylaxis, acute kidney injury, headache, dizziness, tremors, balance disorders, amnesia, ataxia, attention disorders, memory impairment, hyperactivity, insomnia, neuroergia, hyperirritability, emotional instability, anxiety, personality disorders, abnormal thinking, abdominal pain, diarrhea, dyspepsia, nausea, vomiting, loss of appetite, weight gain, dizziness, diplopia, blurred vision, myalgia, injury, nasopharyngitis, infection, cough, rash, eczema, pruritus

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance

White oval film-coated tablet

Package unit

60 tablets (10 tablets × 6) / PTP