Levitaram 500mg (Levetiracetam)

Adult dose

Levetiracetam treatment may be initiated by intravenous or oral administration. When switching from oral to intravenous administration or vice versa, treatment may be switched directly without dose titration; the total daily dose and dosing frequency should remain the same. The injection is for intravenous administration only and should be infused over 15 minutes. There is no experience with intravenous administration of levetiracetam for more than 4 days. The daily dose should be divided into 2 equal doses and administered twice daily. The premixed product* should be used only when one bag replaces the corresponding dose for monotherapy or adjunctive therapy; it should not be divided into smaller portions. *Premixed products: JW Life Science Co., Ltd. - Levetiram Injection 500mg (levetiracetam 500mg/bag), Levetiram Injection 1000mg (levetiracetam 1000mg/bag) 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 the clinical response, the dose may be increased by 500mg per day [250mg per dose, twice daily] every 2 weeks; the maximum dose is 3000mg per day [1500mg per dose, twice daily]. Adjunctive therapy - Partial-onset seizures, adults (18 years and older) and adolescents (16 years and older) Treatment is initiated at 500mg twice daily. Depending on clinical response and tolerability, the dose may be increased or decreased by 1000mg per day [500mg per dose, twice daily] every 2 to 4 weeks; the maximum recommended dose is 3000mg per day. Adjunctive therapy - Myoclonic seizures in pediatric patients (16 years and older) Treatment is initiated at 500mg twice daily. The dose is increased by 1,000mg per day every 2 weeks to the recommended daily dose of 3,000mg. Efficacy has not been studied at doses below 3,000mg per day. Adjunctive therapy - Primary generalized tonic-clonic seizures (16 years and older), adults (18 years and older) and adolescents (16 years and older) Treatment is initiated at 1,000mg per day [500mg per dose, twice daily]. The dose is increased by 1,000mg per day [500mg per dose, twice daily] every 2 weeks 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. Dose adjustment in adults with renal impairment Normal: ≥ 80 mL/min/1.73m2, 500-1,500mg per dose, twice daily (12-hour intervals) Mild: 50-79 mL/min/1.73m2, 500-1,000mg per dose, twice daily (12-hour intervals) Moderate: 30-49 mL/min/1.73m2, 250-750mg per dose, twice daily (12-hour intervals) Severe: < 30 mL/min/1.73m2, 250-500mg per dose, twice daily (12-hour intervals) End-stage renal disease patients on dialysis(1): - mL/min/1.73m2, 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. No dose adjustment is needed in patients with mild to moderate hepatic impairment. In patients with severe hepatic impairment, creatinine clearance may underestimate renal impairment. Therefore, when creatinine clearance is less than 60mL/min/1.73m2, it is recommended that the daily maintenance dose be reduced by 50%. Older adults (65 years and older): Dose adjustment is recommended in older patients with impaired renal function.

Child dose

Dose adjustment in pediatric patients and adolescents weighing less than 50kg with renal impairment Normal: ≥ 80 ml/min/1.73m2, 10-30mg/kg per dose, twice daily Mild: 50-79 ml/min/1.73m2, 10-20mg/kg per dose, twice daily Moderate: 30-49 ml/min/1.73m2, 5-15mg/kg per dose, twice daily Severe: < 30 ml/min/1.73m2, 5-10 mg/kg per dose, twice daily End-stage renal disease patients on dialysis: --, 10-20mg/kg per dose, once daily(1)(2) (1) A loading dose of 15mg/kg is recommended on the first day of treatment. (2) An additional dose of 5-10mg/kg is recommended after dialysis. Use the following formulas for infants, children, and adolescents. ks= 0.45 (infants under 1 year) ks= 0.55 (children under 13 years and female adolescents) ks= 0.7 (male adolescents) Use of the injection is not recommended in children under 16 years because its safety and efficacy have not been established. Tablet administration is not applicable to children under 4 years; the oral solution should be administered to infants aged 1 month and older. Oral formulations are not recommended for infants under 1 month because of insufficient safety and efficacy data.

This medication may increase the risk of suicidal thoughts or behaviors, so if mood changes, depression, or unusual behavior occur during treatment, the physician should be consulted immediately. CNS side effects such as drowsiness, fatigue, coordination problems, and unusual behavior may occur, thus caution is required. Discontinuation of the medication should not be done abruptly as it may worsen seizures; the dosage should be gradually lowered under a doctor's supervision. Patients with allergies to this medication or its components should not take it, and if an allergic reaction is suspected, medical personnel should be informed immediately. Both the caregiver and patient must recognize and report any suicidal thoughts or depressive symptoms immediately. This medication contains sodium, so patients on a low-sodium diet should consult a physician before use. Patients with impaired kidney function may need dosage adjustments, and physician guidance should be followed. There may be side effects such as a decrease in blood cell counts, hence blood tests should be sought if symptoms like fever, fatigue, or indications of infection arise. Psychiatric side effects or behavioral changes such as aggression may occur; if such symptoms appear, the doctor should be consulted, and dosage adjustment or cessation should be considered. As seizures may worsen, immediate consultation with medical personnel is advised if symptoms escalate. Patients with heart disease or a risk of QT prolongation should have an ECG and be cautious when using this medication. Women who are pregnant or planning to become pregnant should discuss the use of this drug with a physician, as sudden cessation may pose risks to the fetus and mother. Breastfeeding women should carefully decide on the use of this medication due to its potential to be excreted in breast milk and affect the baby. Children and the elderly may need dose adjustments depending on kidney function, and especially infants under 1 month or children under 16 years old have not had confirmed safety and efficacy. Caution is needed while driving or operating machinery due to possible drowsiness or reduced concentration, and it is advisable to avoid potentially hazardous tasks. In the case of overdose, the medication should be removed through vomiting or gastric lavage, as there is no specific antidote and treatment should be based on the symptoms. This drug has relatively low interactions with other medications; however, caution is warranted if used with methotrexate as it may alter blood concentration.

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

This medication should be stored in a sealed container to prevent exposure to air or moisture, preferably at a temperature between 1°C and 30°C. Storing it this way will help maintain the medication's efficacy over time.

Appearance

A colorless, transparent solution filled in a colorless transparent plastic container for injection.

Package unit

105mL