Tinasetam 500mg (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. 1. Monotherapy and adjunctive therapy for partial-onset seizures 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]. 4. Patients with renal impairment Refer to the table below for dose adjustment in adults. Dose adjustment for adult patients with renal impairment Normal: Creatinine clearance ≧ 80 ml/min/1.73m2, dose per administration 500-1,500mg, twice daily (12-hour intervals) Mild: Creatinine clearance 50-79 ml/min/1.73m2, dose per administration 500-1,000mg, twice daily (12-hour intervals) Moderate: Creatinine clearance 30-49 ml/min/1.73m2, dose per administration 250-750mg, twice daily (12-hour intervals) Severe: Creatinine clearance < 30 ml/min/1.73m2, dose per administration 250-500mg, twice daily (12-hour intervals) End-stage renal disease patients on dialysis(1): Creatinine clearance -, dose per administration 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

1. 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 50 kg The initial dose is 10 mg/kg per dose twice daily. Depending on clinical response and tolerability, the dose may be increased to 60 mg/kg per day [30 mg/kg per dose, twice daily]. Dose adjustments should not exceed an increase or decrease of 20 mg/kg per day [10 mg/kg per dose, twice daily] every 2 weeks. Use the lowest effective dose. The maximum recommended dose is 3000mg per day. For children weighing 20 kg or less, it is recommended to initiate treatment with the 100mg/ml oral solution. For children weighing 20–40 kg, initiate treatment at 500mg per day [250mg per dose, twice daily]; the dose may be increased by 500mg per day every 2 weeks, up to a maximum of 1500mg per day [750mg per dose, twice daily]. For children weighing more than 40 kg, initiate treatment at 1000mg per day [500mg per dose, twice daily]; the dose may be increased by 1000mg per day every 2 weeks, up to a maximum of 3000mg per day [1500mg per dose, twice daily]. The dose for children weighing 50 kg or more is the same as the adult dose. 2. Adjunctive therapy for myoclonic seizures in pediatric patients (12 years and older) This drug is initiated at 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 reduced to 250mg per dose twice daily and increased to 500mg per dose 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 studied at doses below 3,000mg per day. 3. Adjunctive therapy for primary generalized tonic-clonic seizures (12 years and older) Adolescents aged 12–17 years weighing 50 kg or more This drug is initiated 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 reduced to 250mg per dose twice daily and increased to 500mg per dose 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. Adolescents aged 12–17 years weighing less than 50 kg This drug is initiated 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 has not been adequately studied at doses below 60mg/kg per day. 4. Patients with renal impairment ks= 0.45 (infants under 1 year) ks= 0.55 (children under 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), 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) On the first day of treatment, a loading dose of 15 mg/kg (0.15ml/kg) is recommended. (2) After dialysis, an additional dose of 5-10 mg/kg (0.05-0.10ml/kg) is recommended. 6. Pediatric patients The oral formulation is not recommended for infants younger than 1 month due to insufficient safety and efficacy data. Tablet administration is not applicable to children 4 years of age or younger; the oral solution should be administered to infants 1 month and older. 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 there may be an increased risk of suicidal thoughts or behaviors during treatment; therefore, patients and caregivers should carefully monitor for these symptoms. During the first 4 weeks of treatment, symptoms such as drowsiness, fatigue, coordination disturbances, and behavior changes may frequently occur, requiring particular attention. Sudden discontinuation of the medication may worsen seizures; thus, the dosage should be gradually reduced as directed by a physician. Patients with allergies to any components of this medication or certain genetic metabolic disorders should not take it. If suicidal thoughts or symptoms of depression occur, medical personnel should be notified immediately, and dosage adjustments may be necessary for patients with poor renal function. This medication can cause a decrease in blood cell counts, abnormal behaviors, aggression, worsening seizures, and heart rhythm abnormalities; therefore, patients should consult medical personnel if any unusual symptoms occur. Pregnant or breastfeeding women should discuss the use of this medication with their healthcare provider, and if breastfeeding, they should consider whether to discontinue nursing as the drug can pass into breast milk. Caution is needed when driving or operating machinery as drowsiness or decreased concentration may occur. In case of overdose, immediate emergency treatment is required, as there is no specific antidote, and symptomatic treatment is necessary. This drug generally has minimal interactions with other medications, but should be taken with caution as changes in blood concentration may occur with certain drugs, so patients should inform medical personnel of any other medications being taken. In children and the elderly, careful dosage adjustments and monitoring are necessary, and the medication is only recommended for children aged 1 month and older. This medication helps control seizures, but if any unusual symptoms or discomfort occur while taking it, patients must consult a healthcare professional.

• suicidal ideation
• suicidal behavior
• depression
• abnormal changes in mood and behavior
• drowsiness
• fatigue
• coordination impairment
• behavioral abnormalities
• lethargy
• ataxia

This medication must be stored in a tightly sealed container to protect it from air and moisture. It is recommended to keep the storage temperature between 1 to 30 degrees Celsius at room temperature. Proper storage will help maintain the effectiveness of the medication for a longer period.

Appearance

Yellow oval film-coated tablets

Package unit

30 tablets/bottle, 120 tablets/bottle