Tinasetam 250mg (Levetiracetam)

Adult dose

Film-coated tablets and oral solution are administered orally, may be taken with or without food, and should be taken with plenty of water. The daily dose should be divided into 2 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 change may be made directly without dose titration; the total daily dose and frequency of administration should remain the same. Monotherapy and adjunctive therapy for partial-onset seizures (4 years and older): Adults (18 years and older) Initiate treatment with 500 mg twice daily. However, based on the physician's assessment of potential adverse reactions relative to seizure reduction, the initial dose may be reduced to 250 mg twice daily and increased to 500 mg twice daily after 2 weeks. Depending on clinical response and tolerability, the dose may be increased or decreased every 2 to 4 weeks by 500 mg/day [250 mg per dose, twice daily] or 1000 mg/day [500 mg per dose, twice daily], and the maximum recommended dose is 3000 mg/day [1500 mg per dose, twice daily]. Adjunctive therapy for myoclonic seizures in pediatric patients (12 years and older): Adults Initiate treatment with 500 mg twice daily. However, based on the physician's assessment of potential adverse reactions relative to seizure reduction, the initial dose may be reduced to 250 mg twice daily and increased to 500 mg twice daily after 2 weeks. Depending on clinical response and tolerability, the dose may be increased or decreased every 2 weeks by 500 mg/day [250 mg per dose, twice daily] or 1000 mg/day [500 mg per dose, twice daily]. The maximum recommended dose is 3000 mg/day [1500 mg per dose, twice daily]. Efficacy at doses below 3,000 mg/day has not been studied. Adjunctive therapy for primary generalized tonic-clonic seizures (12 years and older): Adults (18 years and older) Initiate treatment with 1,000 mg/day [500 mg per dose, twice daily]. However, based on the physician's assessment of potential adverse reactions relative to seizure reduction, the initial dose may be reduced to 250 mg twice daily and increased to 500 mg twice daily after 2 weeks. Depending on clinical response and tolerability, the dose may be increased or decreased every 2 weeks by 500 mg/day [250 mg per dose, twice daily] or 1000 mg/day [500 mg per dose, twice daily]. The maximum recommended dose is 3000 mg/day [1500 mg per dose, twice daily]. Efficacy at doses below 3,000 mg/day has not been adequately studied. Patients with renal impairment Because levetiracetam clearance is related to renal function, administer the drug individually according to the patient's renal function. Dose adjustment for adult patients with renal impairment Normal: ≧ 80, 500-1,500mg, twice daily (12-hour intervals) Mild: 50-79, 500-1,000mg, twice daily (12-hour intervals) Moderate: 30-49, 250-750mg, twice daily (12-hour intervals) Severe: < 30, 250-500mg, twice daily (12-hour intervals) End-stage renal disease patients on dialysis(1): -, 500-1,000mg, 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. 5. 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 that the daily maintenance dose be reduced by 50%. 7. 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 (4 years and older): Adolescents aged 12 to 17 years weighing 50 kg or more receive the same dose as adults. Children aged 4 to 11 years and adolescents aged 12 to 17 years weighing less than 50 kg: The initial dose is 10 mg/kg twice daily. Depending on clinical response and tolerability, the dose may be increased to 60 mg/kg/day [30 mg/kg per dose, twice daily]. Dose increases or decreases must not exceed 20 mg/kg/day [10 mg/kg per dose, twice daily] every 2 weeks. Use the lowest effective dose. The maximum recommended dose is 3000 mg/day. Children weighing 20 kg or less: It is recommended to initiate treatment with the 100 mg/ml oral solution. Children weighing 20 to 40 kg: Initiate treatment at 500 mg/day [250 mg per dose, twice daily]. The dose may be increased by 500 mg/day every 2 weeks, up to a maximum of 1500 mg/day [750 mg per dose, twice daily]. Children weighing more than 40 kg: Initiate treatment at 1000 mg/day [500 mg per dose, twice daily]. The dose may be increased by 1000 mg/day every 2 weeks, up to a maximum of 3000 mg/day [1500 mg per dose, twice daily]. Children weighing 50 kg or more: The dose is the same as the adult dose. Adjunctive therapy for myoclonic seizures in pediatric patients (12 years and older): Initiate treatment with 500 mg twice daily. However, based on the physician's assessment of potential adverse reactions relative to seizure reduction, the initial dose may be reduced to 250 mg twice daily and increased to 500 mg twice daily after 2 weeks. Depending on clinical response and tolerability, the dose may be increased or decreased every 2 weeks by 500 mg/day [250 mg per dose, twice daily] or 1000 mg/day [500 mg per dose, twice daily]. The maximum recommended dose is 3000 mg/day [1500 mg per dose, twice daily]. Efficacy at doses below 3,000 mg/day has not been studied. Adjunctive therapy for primary generalized tonic-clonic seizures (12 years and older): Adolescents aged 12 to 17 years weighing 50 kg or more receive the same dose as adults. Adolescents aged 12 to 17 years weighing less than 50 kg: Initiate treatment at 20 mg/kg/day [10 mg/kg per dose, twice daily]. Increase the dose by 20 mg/kg/day [10 mg/kg per dose, twice daily] every 2 weeks to the recommended daily dose of 60 mg/kg [30 mg/kg per dose, twice daily]. Efficacy at doses below 60 mg/kg/day has not been adequately studied. ks= 0.45 (infants younger than 1 year) ks= 0.55 (children younger than 13 years and female adolescents) ks= 0.7 (male adolescents) Dose adjustment for pediatric patients and adolescents weighing less than 50 kg with renal impairment Normal: ≧ 80, 10-30mg/kg(0.10-0.30 ml/kg) twice daily Mild: 50-79, 10-20mg/kg(0.10-0.20 ml/kg) twice daily Moderate: 30-49, 5-15mg/kg (0.05-0.15ml/kg) twice daily Severe: < 30, 5-10 mg/kg (0.05-0.10ml/kg) twice daily End-stage renal disease patients on dialysis: --, 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. Oral formulations are not recommended for infants younger than 1 month because of insufficient safety and efficacy data. Tablets are not suitable for children 4 years or younger; the oral solution should be administered to infants aged 1 month or older. Injection is not recommended for children younger than 16 years because its safety and efficacy have not been established.

This medication is used to treat epilepsy and may increase the risk of suicidal thoughts or behaviors, so patients and guardians should closely monitor for changes in mood or depressive symptoms. Central nervous system adverse reactions such as drowsiness, fatigue, coordination disorders, and behavioral changes may occur during the course of this medication, especially within the first 4 weeks of administration. Stopping the medication abruptly may lead to more frequent seizures, so the dosage must be gradually reduced according to the doctor's instructions. Patients with known allergic reactions to this medication's active ingredient or other components should not take it. Patients with suicidal thoughts, symptoms of depression, or kidney function issues must use this medication with caution, and blood tests to monitor blood cell counts may be necessary. Moreover, this medication can induce psychiatric symptoms such as behavioral changes, aggression, and irritability, so if such changes occur, immediate consultation with a physician is necessary. Seizures may worsen during the initial phase or with dosage increases, and if seizures become more severe, medical personnel should be notified immediately. Patients with heart disease or prolonged QT interval on ECG should be cautious when using this medication. Drowsiness or dizziness may occur while taking this medication, so it is advisable to avoid driving or operating dangerous machinery. Women who are pregnant or planning to become pregnant should consult with a doctor regarding the use of this medication, and breastfeeding mothers should seek advice about whether to discontinue breastfeeding or the medication as the drug can pass into breast milk. Safety and efficacy have not been established in children, especially in infants under 1 month of age, and children under 4 years should be treated with a liquid formulation rather than tablets. Elderly individuals may have a higher risk of side effects due to impaired kidney function, so dosage adjustments may be necessary. This medication has minimal drug interactions with other antiepileptic drugs, oral contraceptives, warfarin, digoxin, etc., but caution is needed when used with methotrexate. In case of overdose, symptoms such as drowsiness, aggression, and decreased consciousness may appear, so immediate medical treatment is required as there is no specific antidote. This medication should be stored out of reach of children and not transferred to other containers for safety.

• suicidal impulses
• suicidal behavior
• depression
• abnormal changes in mood and behavior
• drowsiness
• fatigue
• coordination movement disorders
• abnormal behavior
• weakness
• behavioral disorders

This medicine may be sensitive to air and moisture, so it should be stored in a tightly closed container. The storage temperature should be maintained at room temperature between 1 to 30 degrees. This helps preserve the drug's efficacy and safety over time.

Appearance

White oval film-coated tablet

Package unit

30 tablets/bottle, 120 tablets/bottle