Qupam Tablet 750 Milligrams (Levetiracetam)

Adult dose

The film-coated tablets and oral solution are administered orally and may be taken regardless of meals, with a sufficient amount of water. The daily dose is 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 dose may be given directly without dose titration, and the total daily dose and frequency of administration should remain the same. Monotherapy and adjunctive therapy for partial-onset seizures (4 years and older) Adults (18 years and older) Treatment with this medicine 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, 2 times daily] every 2 to 4 weeks, up to the maximum recommended dose of 3000mg per day. Adjunctive therapy for myoclonic seizures in pediatric patients (12 years and older) Treatment with this medicine 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 for primary generalized tonic-clonic seizures (12 years and older) Adults (18 years and older) Treatment with this medicine is initiated at 1,000mg per day [500mg per dose, 2 times daily]. The dose is increased by 1,000mg per day [500mg per dose, 2 times daily] every 2 weeks to the recommended daily dose of 3,000mg [1,500mg per dose, 2 times daily]. Efficacy has not been adequately studied at doses below 3,000mg per day. Patients with renal impairment Because levetiracetam clearance is related to renal function, the dose should be individualized according to the patient's renal function. Refer to the table below for dose adjustment in adults. Dosage adjustment for adult patients with renal impairment Normal, creatinine clearance ≧ 80 ml/min/1.73m2: 500-1,500mg per dose, 2 times daily (12-hour interval) Mild, creatinine clearance 50-79 ml/min/1.73m2: 500-1,000mg per dose, 2 times daily (12-hour interval) Moderate, creatinine clearance 30-49 ml/min/1.73m2: 250-750mg per dose, 2 times daily (12-hour interval) Severe, creatinine clearance < 30 ml/min/1.73m2: 250-500mg per dose, 2 times daily (12-hour interval) End-stage renal disease patients on dialysis(1), creatinine clearance -: 500-1,000mg per dose, 1 time 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. The patient's creatinine clearance (CLCr,ml/min) value is required to use the table. In adults, it can be obtained from the serum creatinine (mg/dl) value using the formula below. Thereafter, CLcr is adjusted according to body surface area (BSA) as follows. 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, when creatinine clearance is less than 60mL/min/1.73m2, it is recommended that the daily maintenance dose be reduced by 50%. Elderly patients (65 years and older) Dose adjustment is recommended in elderly patients with reduced renal function.

Child dose

Monotherapy and adjunctive therapy for partial-onset seizures (4 years and older) Adolescents weighing 50kg or more (12~17 years): Same as the adult dose. Children aged 4~11 years and adolescents weighing less than 50kg aged 12~17 years: The initial dose is 10mg/kg per dose, 2 times daily. Depending on clinical response and tolerability, the dose may be increased up to 60mg/kg per day [30mg/kg per dose, 2 times daily]. Dose changes should not exceed an increase or decrease of 20mg/kg per day [10mg/kg per dose, 2 times daily] every 2 weeks. Use the lowest effective dose. The maximum recommended dose is 3000mg per day. Children weighing 20kg or less: It is recommended to initiate treatment with the 100mg/ml oral solution. Children weighing 20~40kg: Treatment is initiated at 500mg per day [250mg per dose, 2 times daily] and may be increased by 500mg per day every 2 weeks, up to a maximum of 1500mg per day [750mg per dose, 2 times daily]. Children weighing more than 40kg: Treatment is initiated at 1000mg per day [500mg per dose, 2 times daily] and may be increased by 1000mg per day every 2 weeks, up to a maximum of 3000mg per day [1500mg per dose, 2 times daily]. Children weighing 50kg or more: Same as the adult dose. Adjunctive therapy for myoclonic seizures in pediatric patients (12 years and older) 12 years and older: Treatment with this medicine 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 for primary generalized tonic-clonic seizures (12 years and older) Adolescents weighing 50kg or more (12-17 years): Same as the adult dose. Adolescents weighing less than 50kg aged 12-17 years: Treatment with this medicine is initiated at 20mg/kg per day [10mg/kg per dose, 2 times daily]. The dose is increased by 20mg/kg per day [10mg/kg per dose, 2 times daily] every 2 weeks to the recommended daily dose of 60mg/kg [30mg/kg per dose, 2 times daily]. Efficacy has not been adequately studied at doses below 60mg/kg per day. Dosage adjustment for pediatric patients 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, 2 times daily Mild, creatinine clearance 50-79 (ml/min/1.73m2): 10-20mg/kg (0.10-0.20 ml/kg) per dose, 2 times daily Moderate, creatinine clearance 30-49 (ml/min/1.73m2): 5-15mg/kg (0.05-0.15ml/kg) per dose, 2 times daily Severe, creatinine clearance < 30 (ml/min/1.73m2): 5-10 mg/kg (0.05-0.10ml/kg) per dose, 2 times daily End-stage renal disease patients on dialysis, creatinine clearance --: 10-20mg/kg (0.10-0.20 ml/kg) per dose, 1 time 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. ks= 0.45 (infants under 1 year) ks= 0.55 (children and female adolescents under 13 years) ks= 0.7 (male adolescents) Pediatrics The oral formulation is not recommended for infants under 1 month because of insufficient safety and efficacy data. Tablet administration is not applicable to children 4 years and younger, and the oral solution should be administered to infants 1 month and older. The injection is not recommended for children under 16 years, as its safety and efficacy have not been established.

This medication is used for the treatment of epilepsy, and it may increase the risk of suicidal thoughts or behavior, so patients and caregivers should closely monitor for such symptoms. As it affects the central nervous system, side effects such as drowsiness, fatigue, coordination difficulties, and behavioral changes may occur, particularly needing attention during the first 4 weeks of treatment. Discontinuing the medication abruptly may worsen seizures; therefore, the dosage should be gradually reduced according to the physician's instructions. If there is an allergic reaction to this medication's active ingredient or components, it should not be used, and patients with impaired renal or hepatic function may require dose adjustments. If symptoms such as depression, suicidal thoughts, or behavioral changes occur during treatment, medical attention should be sought immediately. This medication may cause various side effects, including reduced blood cell count, rashes, liver dysfunction, and cardiac rhythm changes, so regular testing may be necessary. Women who are pregnant or planning to become pregnant should consult with healthcare professionals before use, and nursing mothers may need to suspend breastfeeding or adjust medication use to avoid transferring the drug through breast milk. Children, elderly individuals, and patients with renal disease should use this medication with particular caution, as symptoms like drowsiness can increase the risk of accidents when operating vehicles or machinery. While there are relatively few drug interactions, caution is needed when taken with methotrexate, as it may alter blood concentration levels. In cases of overdose, emergency measures such as vomiting or gastric lavage may be required, as there is no specific antidote; treatment should follow medical advice. This medication is recommended for administration as a liquid for children, and the use of injectable forms has not been established as safe for infants under 1 month or children under 16 years old. When storing this medication, keep it out of reach of children and avoid transferring to other containers.

• Suicidal thoughts
• suicidal behavior
• depression
• abnormal mood and behavior changes
• drowsiness
• fatigue
• coordination movement disorders
• behavioral abnormalities
• asthenia
• psychotic symptoms

This medication should be stored in a tightly sealed container to prevent air and moisture from entering. It is best to store it at room temperature, between 1 and 30 degrees Celsius.

Appearance

Orange oval film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle