Levi One Tablet 250 Milligrams (Levetiracetam)

Adult dose

Film-coated tablets and the oral solution are administered orally, regardless of meals, and should be taken with plenty of water. The daily dose should be divided into two equal doses and administered twice daily. Levetiracetam treatment may be initiated by intravenous or oral administration. When switching from oral to intravenous administration or vice versa, the route may be changed directly without dose titration; the total daily dose and frequency of administration should remain the same. Monotherapy and adjunctive therapy for partial-onset seizures: Adults (18 years and older) and adolescents weighing 50kg or more (12~17 years): Start this drug at 500mg twice daily. Depending on clinical response and tolerability, the dose may be increased or decreased by 1000mg per day [500mg per dose, twice daily] every 2 to 4 weeks; the maximum recommended dose is 3000mg per day. Adjunctive therapy for primary generalized tonic-clonic seizures: Adults (18 years and older) and adolescents weighing 50kg or more (12-17 years): Start this drug at 1,000mg per day [500mg per dose, twice daily]. The dose is increased by 1,000mg per day [500mg per dose, twice daily] every 2 weeks up to the recommended daily dose of 3,000mg [1,500mg per dose, twice daily]. Efficacy at doses below 3,000mg per day has not been adequately studied. Patients with renal impairment: Since 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 dosage adjustment in adults. Dosage adjustment for adult patients with renal impairment Normal, creatinine clearance ≧ 80 (ml/min/1.73m2): 500-1,500mg per dose, twice daily (12-hour intervals) Mild, creatinine clearance 50-79 (ml/min/1.73m2): 500-1,000mg per dose, twice daily (12-hour intervals) Moderate, creatinine clearance 30-49 (ml/min/1.73m2): 250-750mg per dose, twice daily (12-hour intervals) Severe, creatinine clearance < 30 (ml/min/1.73m2): 250-500mg per dose, twice daily (12-hour intervals) 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 treatment. (2) An additional dose of 250-500mg is recommended after dialysis. Patients with hepatic impairment: No dosage 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): Dosage adjustment is recommended in elderly patients with reduced renal function.

Child dose

Monotherapy and adjunctive therapy for partial-onset seizures (4 years and older) Children aged 4~11 years and adolescents aged 12~17 years weighing less than 50kg: Start at 10mg/kg per dose twice daily. Depending on clinical response and tolerability, the dose may be increased to 60mg/kg per day [30mg/kg per dose, twice daily]; dose adjustments should not exceed increases or decreases of 20mg/kg per day [10mg/kg per dose, twice daily] every 2 weeks. Use the lowest effective dose. The maximum recommended dose is 3000mg per day. Children weighing 20kg or less: It is recommended to start treatment with the 100mg/ml oral solution. Children weighing 20~40kg: Start at 500mg per day [250mg per dose, twice daily]; the dose may be increased by 500mg per day every 2 weeks to a maximum of 1500mg per day [750mg per dose, twice daily]. Children weighing more than 40kg: Start at 1000mg per day [500mg per dose, twice daily]; the dose may be increased by 1000mg per day every 2 weeks to a maximum of 3000mg per day [1500mg per dose, twice daily]. Children weighing 50kg or more: The dose is the same as the adult dose. Adjunctive therapy for myoclonic seizures in pediatric patients (12 years and older): Start this drug at 500mg twice daily. The dose is increased by 1,000mg per day every 2 weeks up to the recommended daily dose of 3,000mg. Efficacy at doses below 3,000mg per day has not been studied. Adjunctive therapy for primary generalized tonic-clonic seizures (12 years and older) Adolescents aged 12-17 years weighing less than 50kg: Start this drug at 20mg/kg per day [10mg/kg per dose, twice daily]. The dose is increased by 20mg/kg per day [10mg/kg per dose, twice daily] every 2 weeks up to the recommended daily dose of 60mg/kg [30mg/kg per dose, twice daily]. Efficacy at doses below 60mg/kg per day has not been adequately studied. Dosage adjustment for 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, creatinine clearance 50-79 (ml/min/1.73m2): 10-20mg/kg(0.10-0.20 ml/kg) twice daily Moderate, creatinine clearance 30-49 (ml/min/1.73m2): 5-15mg/kg (0.05-0.15ml/kg) twice daily Severe, creatinine clearance < 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. Infants under 1 year of age: ks= 0.45 Female children and adolescents under 13 years of age: ks= 0.55 Male adolescents: ks= 0.7 Oral formulations are not recommended for infants under 1 month of age because of insufficient safety and efficacy data. Tablets are not indicated for children 4 years of age and under; infants 1 month of age and older should receive the oral solution. Injection is not recommended for children under 16 years of age because safety and efficacy have not been established.

This drug is used to treat epilepsy, and there may be an increased risk of suicidal thoughts or behaviors during treatment. Patients should closely monitor for symptoms of depression or changes in mood and behavior and should notify healthcare professionals immediately if unusual symptoms occur. This medication can cause central nervous system side effects such as drowsiness, fatigue, coordination problems, and behavioral changes, particularly within the first 4 weeks. Sudden discontinuation can exacerbate seizures, so doses should be reduced gradually under a doctor's guidance. Individuals with allergies to this medication or similar components should not take it, and dose adjustments may be necessary for patients with impaired kidney function. Additionally, blood cell counts may decrease, so blood tests should be conducted if fever or signs of infection occur. This medication can trigger psychiatric symptoms, such as aggression, anxiety, depression, restlessness, and other behavioral abnormalities, and patients should consult with healthcare providers if these symptoms worsen. Seizures may worsen at the beginning of treatment or after dose increases, so immediate consultation with a doctor is required if seizures intensify. Caution is necessary for patients with heart health issues or prolonged QT intervals. Women who are pregnant or breastfeeding must consult with a doctor regarding the use of this medication, and breastfeeding may need to be stopped or medication reassessed due to potential drug transfer through breast milk affecting the baby. Caution is also advised when administering this medication to children and the elderly, particularly those with reduced kidney function needing dose adjustments. Caution is required when driving or operating machinery due to possible drowsiness or decreased concentration. In case of overdose, immediate medical attention is required, as there are no specific antidotes, only symptomatic treatment is necessary. This medication has relatively few interactions with other drugs, but caution is advised regarding the blood concentration changes when used in conjunction with methotrexate. Lastly, this drug should be stored in a safe place out of reach of children.

suicidal thoughts, suicidal behavior, depression, abnormal mood and behavior changes, drowsiness, fatigue, coordination disorder, abnormal behavior, weakness, aggression, anxiety, anger, emotional blunting, depersonalization, emotional instability, hostility, irritability, hallucinations, psychotic symptoms, psychosis, suicide attempt, suicidal ideation, delusional behavior, headache, seizures, dizziness, tremors, balance disorder, amnesia, coordination impairment, ataxia, attention deficit, memory impairment, hyperactivity, insomnia, emotional instability, personality disorder, abnormal thinking, abdominal pain, diarrhea, dyspepsia, nausea, vomiting, loss of appetite, weight gain, vertigo, diplopia, blurred vision, myalgia, injury, nasopharyngitis, infection, cough, rash, eczema, itching, thrombocytopenia, chorea, movement disorders, sensory disturbances, hypersomnolence, gait disturbances, exacerbation of seizures, psychotic disorders, abnormal behavior, confusion state, panic attacks, anger, delirium, obsessive disorder, pancreatitis, liver failure, hepatitis, abnormal liver function tests, weight loss, hyponatremia, toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, hair loss, muscle weakness, pancytopenia, agranulocytosis, leukopenia, neutropenia, eosinophilia, angioedema, anaphylaxis, acute kidney injury, encephalopathy, neuroleptic malignant syndrome, QT interval prolongation on electrocardiogram, rhabdomyolysis, elevated serum CPK, suicidal attempt, sepsis, constipation, palpitations, aphasia, movement disorders, impulsive behavior, psychomotor retardation, edema, cheilitis, abdominal distension, hypersalivation, urticaria, musculoskeletal rigidity, neck pain, polyuria, dyspnea, anxiety, aggression, decreased consciousness, respiratory depression, coma

This medication should be stored in a tightly sealed container to protect it from air and moisture. Additionally, it is advisable to keep it at room temperature between 1 to 30 degrees Celsius.

Appearance

Blue oval film-coated tablet

Package unit

60 tablets/box [10 tablets/PTP x 6]