Tinasetam 1000mg (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 and adjunctive therapy for partial-onset seizures (4 years of age and older): Adults (18 years of age and older) and adolescents weighing 50kg or more (12~17 years) Start this drug at 500mg twice daily. However, based on the physician's assessment of potential adverse reactions relative to seizure reduction, the initial dose may be lowered to 250mg twice daily and increased to 500mg twice daily after 2 weeks. Depending on clinical response and tolerability, the dose may be increased or decreased every 2 to 4 weeks by 500mg per day [250mg per dose, twice daily] or 1000mg per day [500mg per dose, twice daily]. The maximum recommended dose is 3000mg per day [1500mg per dose, twice daily]. Adjunctive therapy for primary generalized tonic-clonic seizures (12 years of age and older): Adults (18 years of age and older) and adolescents weighing 50kg or more (12-17 years) Start this drug at 1,000mg per day [500mg per dose, twice daily]. However, based on the physician's assessment of potential adverse reactions relative to seizure reduction, the initial dose may be lowered to 250mg twice daily and increased to 500mg twice daily after 2 weeks. Depending on clinical response and tolerability, the dose may be increased or decreased every 2 weeks by 500mg per day [250mg per dose, twice daily] or 1000mg per day [500mg per dose, twice daily]. The maximum recommended dose is 3000mg per day [1500mg 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. To use the table, the patient's creatinine clearance (CLCr,ml/min) value is required; in adults, this can be calculated from the serum creatinine (mg/dl) level using the formula below. CLcr is then adjusted according to body surface area (BSA) as follows. 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) Mild: creatinine clearance 50-79 ml/min/1.73m2, 500-1,000mg per dose, twice daily (12-hour interval) Moderate: creatinine clearance 30-49 ml/min/1.73m2, 250-750mg per dose, twice daily (12-hour interval) Severe: creatinine clearance < 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 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

Monotherapy and adjunctive therapy for partial-onset seizures (4 years and older) 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 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. Use the following formulas for infants, children, and adolescents. 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: Creatinine clearance ≧ 80 ml/min/1.73m2, dose and regimen per administration 10-30mg/kg(0.10-0.30 ml/kg) twice daily Mild: Creatinine clearance 50-79 ml/min/1.73m2, dose and regimen per administration 10-20mg/kg(0.10-0.20 ml/kg) twice daily Moderate: Creatinine clearance 30-49 ml/min/1.73m2, dose and regimen per administration 5-15mg/kg (0.05-0.15ml/kg) twice daily Severe: Creatinine clearance < 30 ml/min/1.73m2, dose and regimen per administration 5-10 mg/kg (0.05-0.10ml/kg) twice daily End-stage renal disease patients on dialysis: Creatinine clearance --, dose and regimen per administration 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 for the treatment of epilepsy and carries a risk of mental health issues such as suicidal thoughts or behavior, and depression, so patients taking the medication should be closely monitored for these symptoms. This medication can cause central nervous system side effects such as drowsiness, fatigue, coordination disturbances, and behavioral abnormalities, particularly in the first 4 weeks of treatment. Abruptly stopping the medication may worsen seizures, so the dosage should be gradually reduced according to a doctor's instructions. Patients with allergies to the active ingredient or other components of the medication should not take it, and patients with kidney or liver function issues may require dose adjustment. Reduced blood cell counts, abnormal behavior, aggression, worsening of seizures, and rarely, cardiac rhythm disturbances have been reported. If these symptoms occur, immediate consultation with medical personnel is necessary. If psychiatric symptoms or mood changes occur during treatment, inform medical personnel, and consider dose adjustment or discontinuation if necessary. Women who are pregnant or planning to become pregnant should consult with medical personnel before taking this medication, and nursing mothers are advised to discontinue breastfeeding, as the drug may be passed through breast milk. Caution should be exercised when administering to children or the elderly, particularly regarding dosage adjustment and monitoring for side effects. Drowsiness or decreased concentration may occur when driving or operating machinery, so caution is required. In cases of overdose, symptoms may include drowsiness, aggression, and decreased consciousness, necessitating immediate emergency treatment. This medication generally has a low potential for interactions with other drugs, but caution is warranted when used in conjunction with certain medications, so inform medical personnel of any other medications being taken. To use this medication safely, adhere strictly to the prescribed dosage and usage, and consult an expert promptly if any unusual symptoms appear.

• Suicidal impulses
• suicidal behavior
• depression
• abnormal mood and behavior changes
• drowsiness
• fatigue
• coordination disorders
• abnormal behavior
• asthenia
• behavioral disorders

This medication may be sensitive to air or moisture; therefore, it should be stored in a tightly sealed container. Additionally, it is best to keep it at room temperature between 1 to 30 degrees Celsius, away from excessive heat or cold, to maintain its effectiveness for a longer period.

Appearance

White oval film-coated tablet

Package unit

30 tablets per bottle