Donggu Levetiracetam Tablet 250 mg

Adult dose

The film-coated tablets and oral solution are administered orally and may be taken with or without food. Take with an adequate amount 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 same dose may be given without dose titration, and the total daily dose and dosing frequency should remain the same. Monotherapy — Adults and adolescents aged 16 years and older: The initial dose is 250mg twice daily. After 2 weeks, increase to 500mg twice daily. Depending on clinical response, the dose may be increased by 500mg/day [250mg per dose, twice daily] every 2 weeks, up to a maximum dose of 3000mg/day [1500mg per dose, twice daily]. Adjunctive therapy — 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/day [500mg per dose, twice daily] every 2 to 4 weeks. The maximum recommended dose is 3000mg/day. Partial-onset seizures — The dose for children weighing 50kg or more is the same as the adult dose. Myoclonic seizures in pediatric patients (12 years and older): Start this drug at 500mg twice daily. Increase the dose by 1,000mg/day every 2 weeks to the recommended daily dose of 3,000mg. Efficacy at doses below 3,000mg/day has not been studied. Primary generalized tonic-clonic seizures (12 years and older), adults (18 years and older) and adolescents weighing 50kg or more (12-17 years): Start this drug at 1,000mg/day [500mg per dose, twice daily]. Increase the dose by 1,000mg/day [500mg per dose, twice daily] every 2 weeks to the recommended daily dose of 3,000mg [1,500mg per dose, twice daily]. Efficacy at doses below 3,000mg/day has not been adequately studied. Patients with renal impairment: Because levetiracetam clearance is related to renal function, adjust the dose individually according to the patient's renal function. Refer to the table below for dose adjustment in adults. Dose adjustment for adults with renal impairment — Normal, creatinine clearance ≧ 80 (ml/min/1.73m2): 500-1,500mg per dose, twice daily (12-hour intervals) Mild, 50-79: 500-1,000mg per dose, twice daily (12-hour intervals) Moderate, 30-49: 250-750mg per dose, twice daily (12-hour intervals) Severe, < 30: 250-500mg per dose, twice daily (12-hour intervals) End-stage renal disease patients on dialysis(1), -: 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. 5. Patients with hepatic impairment: No dose adjustment is needed 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%. 6. Children: Oral formulations are not recommended for infants younger than 1 month because of insufficient safety and efficacy data. Tablets are not applicable for children 4 years of age or younger; the oral solution should be administered to infants 1 month of age or older. Injection is not recommended for children younger than 16 years because safety and efficacy have not been established. 7. Elderly patients (65 years and older): Dose adjustment is recommended in elderly patients with impaired renal function.

Child dose

Adjunctive therapy — Partial-onset seizures, children aged 4 to 11 years and adolescents aged 12 to 17 years weighing less than 50kg: Start with 10mg/kg per dose twice daily. Depending on clinical response and tolerability, the dose may be increased up to 60mg/kg/day [30mg/kg per dose, twice daily]. Dose changes should not exceed an increase or decrease of 20mg/kg/day [10mg/kg per dose, twice daily] every 2 weeks. Use the lowest effective dose. Recommended doses for children and adolescents — 15-20kg(1), 20mg/kg/day (twice daily): 300mg-400mg/day [150-200mg per dose, twice daily]; 40mg/kg/day (twice daily): 600mg-800mg/day [300-400mg per dose, twice daily]; 60mg/kg/day (twice daily): 900mg-1,200mg/day [450-600mg per dose, twice daily] 20.1-40kg, 20mg/kg/day (twice daily): 500mg/day [250mg per dose, twice daily]; 40mg/kg/day (twice daily): 1,000mg/day [500mg per dose, twice daily]; 60mg/kg/day (twice daily): 1,500mg/day [750mg per dose, twice daily] 40.1-50kg(2), 20mg/kg/day (twice daily): 1,000mg/day [500mg per dose, twice daily]; 40mg/kg/day (twice daily): 2,000mg/day [1,000mg per dose, twice daily]; 60mg/kg/day (twice daily): 3,000mg/day [1,500mg per dose, 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. Primary generalized tonic-clonic seizures (12 years and older), adolescents aged 12-17 years weighing less than 50kg: Start this drug at 20mg/kg/day [10mg/kg per dose, twice daily]. Increase the dose by 20mg/kg/day [10mg/kg per dose, twice daily] every 2 weeks to the recommended daily dose of 60mg/kg [30mg/kg per dose, twice daily]. Efficacy at doses below 60mg/kg/day has not been adequately studied. Dose adjustment for children 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) per dose, twice daily Mild, 50-79: 10-20mg/kg (0.10-0.20 ml/kg) per dose, twice daily Moderate, 30-49: 5-15mg/kg (0.05-0.15ml/kg) per dose, twice daily Severe, < 30: 5-10 mg/kg (0.05-0.10ml/kg) per dose, twice daily End-stage renal disease patients on dialysis, --: 10-20mg/kg (0.10-0.20 ml/kg) per dose, 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. Formula for calculating the dose in children with renal impairment: ks= 0.45 (infants younger than 1 year); ks= 0.55 (children younger than 13 years and adolescent females); ks= 0.7 (adolescent males)

This medication is used for the treatment of epilepsy and may increase the risk of suicidal thoughts or behaviors; thus, mood changes or unusual behaviors should be closely monitored during use. When starting treatment or adjusting the dosage, central nervous system side effects such as drowsiness, fatigue, coordination impairments, and behavioral changes may occur, so caution is needed. Abruptly stopping the medication can worsen seizures, so the dosage should be decreased gradually according to the physician's instructions. This medication should not be taken if there is a hypersensitivity reaction, and patients with impaired renal function may require dosage adjustments. If symptoms of depression or suicidal thoughts arise during treatment, or if there are unusual changes in behavior, medical personnel must be notified immediately. Blood tests may show decreased white blood cell counts, so testing is necessary if there are symptoms of fever or infection. This medication may also induce behavioral changes such as psychotic symptoms, aggression, or anxiety, so a doctor should be consulted if these symptoms occur. Caution is advised in patients with heart disease or prolonged QT intervals on an ECG. During pregnancy, the effects on the fetus are not fully understood, and caution is warranted; during breastfeeding, the medication can be passed to the infant through breast milk, so consult a physician about breastfeeding. Drowsiness or decreased concentration may occur while driving or operating machinery, so caution is needed. In case of overdose, symptoms such as drowsiness, aggression, and decreased consciousness may occur, requiring emergency care. This medication has relatively few interactions with other drugs, but caution is warranted when used in combination with certain medications, so all medications being taken should be reported to medical personnel. Caution should be exercised when administering this medication to children or the elderly, and it is safe to administer the liquid form for children over 1 month of age. When storing the medication, keep it out of reach of children and do not transfer it to another container.

• suicidal thoughts
• suicidal behavior
• depression
• abnormal changes in mood and behavior
• drowsiness
• fatigue
• akathisia
• behavioral abnormalities
• weakness
• behavioral disorders

Store this medication in a tightly closed container to protect it from air and humidity. It is advisable to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance

Blue oval film-coated tablet

Package unit

30 tablets/bottle, 120 tablets/bottle