Qupam Injection 500 mg (Levetiracetam)

Adult dosage

Levetiracetam treatment may be initiated by intravenous or oral administration. When switching from oral to intravenous administration or vice versa, treatment may be given immediately without dose titration; the total daily dose and frequency of administration should remain the same. The injection is for intravenous administration only and must be diluted before administration. Dilute the dose in 100mL of a compatible diluent and infuse intravenously over 15 minutes. 250mg: 2.5mL (1/2 vial), 100mL, 15 minutes, twice daily, 500mg/day 500mg: 5mL (1 vial), 100mL, 15 minutes, twice daily, 1000mg/day 1000mg: 10mL (2 vials), 100mL, 15 minutes, twice daily, 2000mg/day 1500mg: 15mL (3 vials), 100mL, 15 minutes, twice daily, 3000mg/day There is no experience with intravenous administration of levetiracetam for more than 4 days. Film-coated tablets and oral solution are administered orally and may be taken with or without food. Take with sufficient water. The total daily dose should be divided into 2 equal doses administered twice daily. Monotherapy Adults and adolescents aged 16 years and older: The initial dose is 250mg twice daily. After 2 weeks, increase the dose to 500mg twice daily. Depending on clinical response, the dose may be increased by 500mg/day [250mg per dose, twice daily] every 2 weeks; the maximum dose is 3000mg/day [1500mg per dose, twice daily]. Adjunctive therapy 1. Partial-onset seizures Adults (18 years and older) and adolescents (16 years and older): Initiate treatment with 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. 2. Myoclonic seizures in pediatric patients (16 years and older): Initiate treatment with 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. 3. Primary generalized tonic-clonic seizures (16 years and older) Adults (18 years and older) and adolescents (16 years and older): Initiate treatment with 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. 4. 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 adjustments in adults. Normal, ≥ 80 mL/min/1.73m2: 500-1,500mg, twice daily (12-hour intervals) Mild, 50-79 mL/min/1.73m2: 500-1,000mg, twice daily (12-hour intervals) Moderate, 30-49 mL/min/1.73m2: 250-750mg, twice daily (12-hour intervals) Severe, < 30 mL/min/1.73m2: 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 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, a 50% reduction in the daily maintenance dose is recommended. 7. Older adults (65 years and older) Dose adjustment is recommended in elderly patients with reduced renal function.

Children's dosage

Pediatric patients with renal impairment and adolescents weighing less than 50kg: Normal (creatinine clearance ≥ 80 ml/min/1.73m2): 10-30mg/kg twice daily Pediatric patients with renal impairment and adolescents weighing less than 50kg: Mild (creatinine clearance 50-79 ml/min/1.73m2): 10-20mg/kg twice daily Pediatric patients with renal impairment and adolescents weighing less than 50kg: Moderate (creatinine clearance 30-49 ml/min/1.73m2): 5-15mg/kg twice daily Pediatric patients with renal impairment and adolescents weighing less than 50kg: Severe (creatinine clearance < 30 ml/min/1.73m2): 5-10 mg/kg twice daily Pediatric patients with renal impairment and adolescents weighing less than 50kg: End-stage renal disease patients on dialysis (creatinine clearance --): 10-20mg/kg 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. ks= 0.45 (infants under 1 year) ks= 0.55 (children and female adolescents under 13 years) ks= 0.7 (male adolescents) 6. Pediatric patients Use of the injection is not recommended in children under 16 years of age because its safety and efficacy have not been established. Tablet administration is not applicable to children 4 years of age or younger, and the oral solution should be administered to infants aged 1 month and older. Oral formulations are not recommended for infants under 1 month of age due to insufficient safety and efficacy data.

This medication may increase the risk of suicidal thoughts or behavior, so if depression or mood changes occur during treatment, patients should inform their healthcare provider immediately. It can affect the central nervous system, causing drowsiness, fatigue, coordination difficulties, and behavioral abnormalities, particularly within the first 4 weeks of treatment. Suddenly stopping this medication may worsen seizures, so the dosage must be reduced gradually under the supervision of a doctor. Patients with an allergy to this medication's ingredients should not use it. Patients with suicidal thoughts or depression symptoms should be closely monitored while taking this medication, and if symptoms appear, they should consult their healthcare provider immediately. Patients on a low-sodium diet should consider the sodium content of this drug. Patients with poor kidney function may require dosage adjustments, and those with severely impaired liver function should undergo kidney function tests before administration. As the medication may cause a decrease in blood cell count, patients who experience weakness, fever, or symptoms of infection should undergo blood tests. This medication may induce psychiatric changes such as irritability and aggression; if such symptoms appear, consideration should be given to dosage adjustment or discontinuation. Seizures may worsen during the initiation of treatment or dose increases, so any abnormal symptoms should be reported to a healthcare provider immediately. Caution is needed when administering this drug to patients with heart disease or those with QT interval prolongation on an electrocardiogram. Patients driving or operating machinery should be cautious of drowsiness or decreased concentration, especially during the early phase of treatment or when changing the dosage. Women who are pregnant or planning to become pregnant should consult their healthcare provider regarding the use of this medication, as sudden discontinuation may pose risks to both the fetus and mother. During breastfeeding, this medication may be excreted in breast milk and affect the baby, so consultation with a healthcare provider regarding stopping breastfeeding or discontinuing the medication is advised. Safety has not been established for infants under 1 month, and liquid formulations should be used instead of tablets for children under 4 years. Elderly patients, who often have reduced kidney function, should have their dosages carefully determined. In cases of overdose, symptoms such as drowsiness, agitation, and reduced consciousness may occur, and since there are no specific antidotes, appropriate treatment should be administered at a hospital immediately. This medication has relatively few pharmacokinetic interactions with other antiepileptic drugs or oral contraceptives, but when used with methotrexate, blood concentration monitoring is required. Adverse reactions during treatment may include drowsiness, fatigue, headache, behavioral changes, depression, aggression, reduction in blood cells, liver dysfunction, skin rash, etc., so these symptoms should be reported to a healthcare provider.

• suicidal thoughts
• suicidal behavior
• depression
• drowsiness
• fatigue
• cooperation movement disorder
• behavioral abnormalities
• asthenia
• behavioral disorder
• aggression

Store this medication in a sealed container to prevent exposure to air, and keep it at room temperature between 1 degree and 30 degrees Celsius. This helps maintain the efficacy and safety of the medication.

Appearance

A colorless and transparent liquid contained in a colorless and transparent glass vial.

Package unit

1 vial (5 mL) × 10