Qupam Liquid (Levetiracetam)

Adult dose

The film-coated tablets and oral solution are administered orally and may be taken with or without food, with a sufficient 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 drug may be administered immediately without dose titration; the total daily dose and frequency of administration should remain the same. 1. Monotherapy 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 of age) Treatment with this drug is initiated 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. 2. Adjunctive therapy for partial-onset seizures (1 month of age and older) Adults (18 years of age and older) and adolescents weighing 50kg or more (12~17 years of age) Treatment with this drug is initiated 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. 3. Adjunctive therapy for myoclonic seizures in pediatric patients (12 years of age and older) 4. 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 of age) Treatment with this drug is initiated at 1,000mg/day [500mg per dose, twice daily]. The dose is increased 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. 5. Patients with renal impairment Since levetiracetam clearance is related to renal function, administer the drug individually according to the patient's renal function. Refer to the table below for dose adjustment in adults. To use the table, the patient's creatinine clearance (CLCr, ml/min) is required. In adults, it can be calculated from the serum creatinine (mg/dl) level using the formula below. CLcr (ml/min) = [140-age (years)] × body weight (kg) (× 0.85: for women) 72 × serum creatinine (mg/dl) CLcr is then adjusted for body surface area (BSA) as follows. CLcr (ml/min/1.73m2) = CLcr (ml/min) × 1.73 body surface area (BSA, m2) Dose adjustment in adult patients with renal impairment Normal: Creatinine clearance ≧ 80 (ml/min/1.73m2), 500-1,500mg per dose, twice daily (12-hour intervals) Mild: Creatinine clearance 50-79 (ml/min/1.73m2), 500-1,000mg per dose, twice daily (12-hour intervals) Moderate: Creatinine clearance 30-49 (ml/min/1.73m2), 250-750mg per dose, twice daily (12-hour intervals) Severe: Creatinine clearance < 30 (ml/min/1.73m2), 250-500mg per dose, twice daily (12-hour intervals) 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 treatment. (2) An additional dose of 250-500mg is recommended after dialysis. 6. Patients with hepatic impairment No dose adjustment is required 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%. 8. Elderly patients (65 years of age and older) Dose adjustment is recommended in elderly patients with impaired renal function.

Child dose

1. Monotherapy for partial-onset seizures (4 years of age and older) Children 4–11 years of age and adolescents 12–17 years of age 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 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 dose for children weighing 50 kg or more is the same as the adult dose. 15 kg(1): Initial dose 150 mg per dose, twice daily; maximum dose 450 mg per dose, twice daily 20 kg(1): Initial dose 200 mg per dose, twice daily; maximum dose 600 mg per dose, twice daily 25 kg(1): Initial dose 250 mg per dose, twice daily; maximum dose 750 mg per dose, twice daily 50 kg or more(2): Initial dose 500 mg per dose, twice daily; maximum dose 1500 mg per dose, twice daily (1) For children weighing 20 kg or less, it is recommended to initiate treatment with the 100 mg/ml oral solution. (2) The dosage and administration for children and adolescents weighing 50 kg or more are the same as for adults. 2. Adjunctive therapy for partial-onset seizures (1 month of age and older) Infants 6–23 months of age, children 2–11 years of age, and adolescents 12–17 years of age 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 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 dose for children weighing 50 kg or more is the same as the adult dose. 6 kg(1): Initial dose 60 mg per dose, twice daily; maximum dose 180 mg per dose, twice daily 10 kg(1): Initial dose 100 mg per dose, twice daily; maximum dose 300 mg per dose, twice daily 15 kg(1): Initial dose 150 mg per dose, twice daily; maximum dose 450 mg per dose, twice daily 20 kg(1): Initial dose 200 mg per dose, twice daily; maximum dose 600 mg per dose, twice daily 25 kg: Initial dose 250 mg per dose, twice daily; maximum dose 750 mg per dose, twice daily 50 kg or more(2): Initial dose 500 mg per dose, twice daily; maximum dose 1500 mg per dose, twice daily (1) For children weighing 20 kg or less, it is recommended to initiate treatment with the 100 mg/ml oral solution. (2) The dosage and administration for children and adolescents weighing 50 kg or more are the same as for adults. Infants 1–6 months of age The initial dose is 7 mg/kg per dose twice daily. Depending on clinical response and tolerability, the dose may be increased to 21 mg/kg per dose twice daily. Dose adjustments should not exceed an increase or decrease of 7 mg/kg per dose twice daily every 2 weeks. Use the lowest effective dose. Treatment in infants should be initiated with the 100 mg/ml oral solution. 4 kg: Initial dose 28 mg (0.3ml) per dose, twice daily; maximum dose 84 mg (0.85ml) per dose, twice daily 5 kg: Initial dose 35 mg (0.35ml) per dose, twice daily; maximum dose 105 mg (1.05ml) per dose, twice daily 7 kg: Initial dose 49 mg (0.5ml) per dose, twice daily; maximum dose 147 mg (1.5ml) per dose, twice daily 3. Adjunctive therapy for myoclonic seizures in pediatric patients (12 years of age and older) Treatment is initiated at 500 mg twice daily. The dose is increased by 1,000 mg per day every 2 weeks up to the recommended daily dose of 3,000 mg. Efficacy has not been studied at doses below 3,000 mg per day. 4. Adjunctive therapy for primary generalized tonic-clonic seizures (12 years of age and older) Adolescents 12–17 years of age weighing less than 50 kg Treatment is initiated at 20 mg/kg per day [10 mg/kg per dose, twice daily]. The dose is increased by 20 mg/kg per day [10 mg/kg per dose, twice daily] every 2 weeks up to the recommended daily dose of 60 mg/kg [30 mg/kg per dose, twice daily]. Efficacy has not been adequately studied at doses below 60 mg/kg per day. 15 kg(1): Initial dose 150 mg per dose, twice daily; maximum dose 450 mg per dose, twice daily 20 kg(1): Initial dose 200 mg per dose, twice daily; maximum dose 600 mg per dose, twice daily 25 kg: Initial dose 250 mg per dose, twice daily; maximum dose 750 mg per dose, twice daily 50 kg or more(2): Initial dose 500 mg per dose, twice daily; maximum dose 1500 mg per dose, twice daily (1) For children weighing 20 kg or less, it is recommended to initiate treatment with the 100 mg/ml oral solution. (2) The dosage and administration for children and adolescents weighing 50 kg or more are the same as for adults. Patients with renal impairment ks= 0.45 (infants under 1 year of age) ks= 0.55 (children under 13 years of age and female adolescents) ks= 0.7 (male adolescents) Dose adjustment for infants, children, and adolescents weighing less than 50 kg with renal impairment Infants 1–6 months of age, normal (≧ 80): 7-21mg/kg(0.07-0.21ml/kg), twice daily Infants 1–6 months of age, mild (50-79): 7-14mg/kg(0.07-0.14ml/kg), twice daily Infants 1–6 months of age, moderate (30-49): 3.5-10.5mg/kg(0.035-0.105ml/kg), twice daily Infants 1–6 months of age, severe (< 30): 3.5-7mg/kg(0.035-0.07 ml/kg), twice daily Infants 1–6 months of age, end-stage renal disease on dialysis(1)(--): 7-14mg/kg(0.07-0.14ml/kg), once daily (1)(3) Infants 6–23 months of age, children, and adolescents weighing less than 50 kg, normal (≧ 80): 10-30mg/kg(0.10-0.30 ml/kg), twice daily Infants 6–23 months of age, children, and adolescents weighing less than 50 kg, mild (50-79): 10-20mg/kg(0.10-0.20 ml/kg), twice daily Infants 6–23 months of age, children, and adolescents weighing less than 50 kg, moderate (30-49): 5-15mg/kg (0.05-0.15ml/kg), twice daily Infants 6–23 months of age, children, and adolescents weighing less than 50 kg, severe (< 30): 5-10 mg/kg (0.05-0.10ml/kg), twice daily Infants 6–23 months of age, children, and adolescents weighing less than 50 kg, end-stage renal disease on dialysis(1)(--): 10-20mg/kg(0.10-0.20 ml/kg), once daily (2)(4) (1) On the first day of treatment, a loading dose of 10.5 mg/kg (0.105 ml/kg) is recommended. (2) On the first day of treatment, a loading dose of 15 mg/kg (0.15 ml/kg) is recommended. (3) After dialysis, an additional dose of 3.5-7 mg/kg (0.035-0.07 ml/kg) is recommended. (4) After dialysis, an additional dose of 5-10 mg/kg (0.05-0.10 ml/kg) is recommended. 7. Pediatric patients The oral formulation is not recommended for infants younger than 1 month because of insufficient safety and efficacy data. Tablets are not suitable for children 4 years of age or younger, and the oral solution should be administered to infants 1 month of age and older. The safety and efficacy of the injectable formulation have not been established in children under 16 years of age; therefore, its use is not recommended.

This medication is used for the treatment of epilepsy, and there may be an increased risk of suicidal thoughts or behavior, so patients taking it should be closely monitored for changes in mood or behavior. Psychiatric adverse reactions, such as drowsiness, fatigue, coordination disorders, and behavioral changes, can commonly occur within the first 4 weeks of treatment. Sudden discontinuation of this medication may worsen seizures; therefore, the dosage should be gradually reduced according to the physician's instructions. Patients allergic to the active ingredient or any of the components, and those with fructose intolerance, should not take this medication. Since it contains ingredients that may trigger allergic reactions, patients with a history of allergies should take it with caution. Patients with impaired kidney function may need dosage adjustments, and patients with severely impaired liver function should undergo kidney function tests prior to administration. This medication can cause behavioral changes, aggression, mood changes, and other psychiatric symptoms, so if these symptoms appear, a physician should be consulted immediately. In some cases, seizures may worsen, so any symptoms should be reported to healthcare personnel. There is a risk of QT interval prolongation on electrocardiograms, so patients with heart disease or electrolyte imbalances should be cautious. Drowsiness or decreased concentration may occur when taking this medication, so caution is required when driving or operating machinery. The effects of this medication on the fetus during pregnancy are not fully understood; therefore, women who are planning to become pregnant or are pregnant should consult with healthcare personnel. If breastfeeding, since this medication is excreted in breast milk, the decision to continue breastfeeding should be made in consultation with a physician. For children, safety has not been established for infants under 1 month old, and administering the liquid form is recommended for children under 4 years old. Elderly patients may be at higher risk for adverse reactions due to decreased kidney function, so dosage adjustments and caution are required. In the event of an overdose, symptoms such as drowsiness, agitation, and impaired consciousness may occur, and since there is no specific antidote, immediate medical attention should be sought. This medication has relatively few drug interactions when used in combination with other antiepileptic drugs or oral contraceptives, but attention should be paid to changes in blood concentration when used with methotrexate. Use a measuring device for dosing and complete consumption within 4 months after opening, keeping it out of reach of children.

• Suicidal thoughts
• suicidal behavior
• depression
• abnormal changes in mood and behavior
• drowsiness
• fatigue
• coordination motor disturbance
• behavioral abnormalities
• weakness
• psychotic symptoms

This medication should be stored in a tightly sealed container to protect it from air and moisture. The storage temperature should maintain room temperature between 1 and 30 degrees Celsius, and it is advisable to use it all within 4 months after opening.

Appearance

A colorless or pale yellowish transparent liquid in a brown glass bottle

Package unit

100 milliliters/bottle