Staletam 1000 mg (Levetiracetam)

Adult dose

Film-coated tablets and oral solution are administered orally and may be taken with or without food. Take with plenty of water. The daily dose should be divided into 2 equal doses and administered twice daily. Levetiracetam treatment may be initiated intravenously or orally. 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 of age and older: Start with an initial dose of 250mg twice daily, increasing to 500mg twice daily after 2 weeks. Depending on clinical response, the dose may be increased every 2 weeks by 500mg per day [250mg per dose, twice daily]. The maximum dose is 3000mg per day [1500mg per dose, twice daily]. Adjunctive therapy — Partial-onset seizures, adults (18 years of age and older): Start this drug at 500mg twice daily. Depending on clinical response and tolerability, the dose may be increased or decreased every 2 to 4 weeks by 1000mg per day [500mg per dose, twice daily]. The maximum recommended dose is 3000mg per day. Adjunctive therapy — Primary generalized tonic-clonic seizures, adults (18 years of age and older): Start this drug at 1,000mg per day [500mg per dose, twice daily]. Increase the dose 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 has not been adequately studied at doses below 3,000mg per day. Patients with renal impairment: Since levetiracetam clearance is related to renal function, administer an individualized dose according to the patient's renal function. See the table below for dose adjustment in adults. Dose adjustment for adult patients with renal impairment - Normal, creatinine clearance ≥ 80 (mL/min/1.73m2): 500-1,500mg per dose, twice daily (12-hour interval) Dose adjustment for adult patients with renal impairment - Mild, creatinine clearance 50-79 (mL/min/1.73m2): 500-1,000mg per dose, twice daily (12-hour interval) Dose adjustment for adult patients with renal impairment - Moderate, creatinine clearance 30-49 (mL/min/1.73m2): 250-750mg per dose, twice daily (12-hour interval) Dose adjustment for adult patients with renal impairment - Severe, creatinine clearance < 30 (mL/min/1.73m2): 250-500mg per dose, twice daily (12-hour interval) Dose adjustment for adult patients with renal impairment - 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 below 60mL/min/1.73m2, a 50% reduction in the daily maintenance dose is recommended. Elderly patients (65 years of age and older): Dose adjustment is recommended in elderly patients with impaired renal function.

Child dose

Adjunctive therapy - partial-onset seizures, adults (18 years and older) and adolescents weighing 50kg or more (12~17 years): This medication is initiated 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 4~11 years and adolescents weighing less than 50kg (12~17 years): The initial dose is 10mg/kg twice daily. Depending on clinical response and tolerability, the dose may be increased to 60mg/kg/day [30mg/kg twice daily]; dose changes should not exceed increases or decreases of 20mg/kg/day [10mg/kg twice daily] 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. Adjunctive therapy - myoclonic seizures in pediatric patients (12 years and older): This medication is initiated at 500mg twice daily. The dose is increased by 1,000mg/day every 2 weeks to the recommended daily dose of 3,000mg. Efficacy has not been studied at doses below 3,000mg/day. Adjunctive therapy - primary generalized tonic-clonic seizures, adults (18 years and older) and adolescents weighing 50kg or more (12-17 years): This medication is initiated at 1,000mg/day [500mg twice daily]. The dose is increased by 1,000mg/day [500mg twice daily] every 2 weeks to the recommended daily dose of 3,000mg [1,500mg twice daily]. Efficacy has not been adequately studied at doses below 3,000mg/day. Adjunctive therapy - primary generalized tonic-clonic seizures, adolescents weighing less than 50kg (12-17 years): This medication is initiated at 20mg/kg/day [10mg/kg twice daily]. The dose is increased by 20mg/kg/day [10mg/kg twice daily] every 2 weeks to the recommended daily dose of 60mg/kg [30mg/kg twice daily]. Efficacy has not been adequately studied at doses below 60mg/kg/day. For infants, children, and adolescents, use the following formula. ks= 0.45 (infants under 1 year) ks= 0.55 (children and female adolescents under 13 years) ks= 0.7 (male adolescents) 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 Dosage adjustment for pediatric patients and adolescents weighing less than 50kg with renal impairment - Mild, creatinine clearance 50-79 (ml/min/1.73m2): 10-20mg/kg(0.10-0.20 ml/kg) twice daily Dosage adjustment for pediatric patients and adolescents weighing less than 50kg with renal impairment - Moderate, creatinine clearance 30-49 (ml/min/1.73m2): 5-15mg/kg (0.05-0.15ml/kg) twice daily Dosage adjustment for pediatric patients and adolescents weighing less than 50kg with renal impairment - Severe, creatinine clearance < 30 (ml/min/1.73m2): 5-10 mg/kg (0.05-0.10ml/kg) twice daily Dosage adjustment for pediatric patients and adolescents weighing less than 50kg with renal impairment - End-stage renal disease patients on dialysis, creatinine clearance --: 10-20mg/kg(0.10-0.20 ml/kg) once daily(1)(2) (1) On the first day of treatment, administration of a loading dose of 15 mg/kg(0.15ml/kg) is recommended. (2) After dialysis, administration of an additional dose of 5-10 mg/kg(0.05-0.10ml/kg) is recommended. Oral formulations are not recommended for infants under 1 month of age due to insufficient safety and efficacy data. Tablet administration is not applicable in children 4 years of age or younger, and the oral solution should be administered to infants 1 month of age or older. Injection is not recommended for children under 16 years of age because its safety and efficacy have not been established.

This medication may increase the risk of suicidal thoughts or behavior, so consult a doctor if experiencing depression or mood changes while taking it. It may affect the central nervous system, causing symptoms such as drowsiness, fatigue, coordination problems, and behavioral changes, so caution is advised. Abruptly discontinuing this medication can worsen seizures, so the dosage should be gradually reduced under a doctor's guidance. Do not take this medication if you are allergic to any of its ingredients. Patients with poor kidney function may require dosage adjustments, and renal function tests are recommended for those with severely impaired liver function. Blood cell counts may decrease, so blood tests may be required if symptoms such as fever, fatigue, or signs of infection occur. This medication can cause behavioral changes, aggression, irritability, and psychiatric symptoms, so if unusual behaviors occur, consult a doctor. Seizures may worsen at the beginning of treatment or with increased dosage, so immediately inform healthcare personnel if symptoms arise. Patients with heart disease or electrolyte imbalances need to be cautious due to the possibility of abnormal ECG readings. During pregnancy, it should be used cautiously due to potential effects on the fetus, and if breastfeeding, discuss with healthcare personnel about the possibility of transferring the medication through breast milk and whether to discontinue breastfeeding or the medication. Children or the elderly may require dosage adjustments depending on kidney function, and the safety of this medication in infants under one month has not been established. Caution is advised when driving or operating machinery due to the potential for drowsiness or decreased concentration. Overdose may cause drowsiness, aggression, and decreased consciousness, and immediate treatment at a hospital is required. This medication has relatively few drug interactions, but caution is advised when taken with methotrexate due to the possibility of increased blood concentration. If any hypersensitivity reaction symptoms such as rash, fever, or lymphadenopathy occur during the use of this medication, discontinue it immediately and inform healthcare personnel.

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

This medication may be sensitive to air or moisture, so it should be stored in a tightly closed container. It is best to maintain a storage temperature between 1 and 30 degrees Celsius. This will help preserve the medication's effectiveness and safety over time.

Appearance

White oval film-coated tablet

Package unit

30 tablets/bottle, 120 tablets/bottle