Retiram Tablet 250 mg (Levetiracetam)

Adult dose

Film-coated tablets and oral solution are administered orally and may be taken without regard to meals; take with plenty of water. The daily dose should be divided into 2 equal doses administered twice daily. Levetiracetam treatment may be initiated by intravenous or oral administration. When switching from oral to intravenous administration or vice versa, the change may be made directly without dose titration; the total daily dose and dosing frequency should remain the same. Monotherapy — Adults: Start with an initial dose of 250mg per dose twice daily, then increase to 500mg per dose twice daily after 2 weeks. 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 — Partial-onset seizures, adults (18 years and older): Start treatment with 500mg per dose 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. Adjunctive therapy — Primary generalized tonic-clonic seizures, adults (18 years and older): Start 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 up 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: 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. Adult patients with renal impairment — Normal, creatinine clearance ≥ 80 (mL/min/1.73m2): Dose per administration 500-1,500mg, twice daily (12-hour intervals) Adult patients with renal impairment — Mild, creatinine clearance 50-79 (mL/min/1.73m2): Dose per administration 500-1,000mg, twice daily (12-hour intervals) Adult patients with renal impairment — Moderate, creatinine clearance 30-49 (mL/min/1.73m2): Dose per administration 250-750mg, twice daily (12-hour intervals) Adult patients with renal impairment — Severe, creatinine clearance < 30 (mL/min/1.73m2): Dose per administration 250-500mg, twice daily (12-hour intervals) Adult patients with renal impairment — End-stage renal disease patients on dialysis(1), creatinine clearance -: Dose per administration 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. No dose adjustment is necessary 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 advisable to reduce the daily maintenance dose by 50%. Elderly patients (65 years and older): Dose adjustment is recommended in elderly patients with reduced renal function.

Child dose

Monotherapy — Adolescents 16 years of age 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 twice daily]. Adjunctive therapy — Partial-onset seizures, adolescents (12~17 years) weighing 50kg or more: Start 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. Adjunctive therapy — Partial-onset seizures, children 4 years to 11 years of age and adolescents 12~17 years weighing less than 50kg: The initial dose is 10mg/kg twice daily. Depending on clinical response and tolerability, the dose may be increased to 60mg/kg/day [30mg/kg per dose, twice daily]; dose adjustments must not exceed increases or decreases of 20mg/kg/day [10mg/kg per dose, twice daily] every 2 weeks. Use the lowest effective dose. The dose for children weighing 50kg or more is the same as the adult dose. Recommended dose for partial-onset seizures — 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] Recommended dose for partial-onset seizures — 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] Recommended dose for partial-onset seizures — 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. Adjunctive therapy — Myoclonic seizures in pediatric patients (12 years of age and older): Start treatment with 500mg twice daily. The dose is increased by 1,000mg/day every 2 weeks up to the recommended daily dose of 3,000mg. Efficacy at doses below 3,000mg/day has not been studied. Adjunctive therapy — Primary generalized tonic-clonic seizures, adolescents (12-17 years) weighing 50kg or more: Start treatment with 1,000mg/day [500mg twice daily]. The dose is increased by 1,000mg/day [500mg per dose, twice daily] every 2 weeks up 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. Adjunctive therapy — Primary generalized tonic-clonic seizures, adolescents 12-17 years weighing less than 50kg: Start treatment with 20mg/kg/day [10mg/kg per dose, twice daily]. The dose is increased by 20mg/kg/day [10mg/kg per dose, twice daily] every 2 weeks up 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. Pediatric patients with renal impairment and adolescents weighing less than 50kg — Normal, creatinine clearance ≥ 80 (ml/min/1.73m2): 10-30mg/kg(0.10-0.30 ml/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(0.10-0.20 ml/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 (0.05-0.15ml/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 (0.05-0.10ml/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(0.10-0.20 ml/kg) once daily(1)(2) (1) On the first day of treatment, a loading dose of 15 mg/kg(0.15ml/kg) is recommended. (2) After dialysis, an additional dose of 5-10 mg/kg(0.05-0.10ml/kg) is recommended. 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) The oral formulation is not recommended for infants under 1 month of age because of insufficient safety and efficacy data. Tablet administration is not applicable to children 4 years of age or younger, and the oral solution should be administered to infants 1 month of age and older. Administration of the injection is not recommended in children under 16 years of age because its safety and efficacy have not been established.

This medication is used for treating epilepsy, and patients and caregivers should closely monitor for an increased risk of suicidal thoughts or behaviors during treatment. It may cause central nervous system side effects such as drowsiness, fatigue, coordination disturbances, and behavioral changes, especially within the first 4 weeks of treatment. Stopping the medication suddenly may worsen seizures, so the dosage should be gradually reduced according to the physician's instructions. Patients with allergies to the ingredients in this medication or to similar chemicals should not use it. Any occurrences of depression, suicidal thoughts, or behavioral changes should be immediately reported to a healthcare professional for consultation. Patients with impaired kidney function may need dosage adjustments, while those with severe liver dysfunction should first undergo kidney function tests. Since blood cell counts may decrease, if symptoms such as fatigue, fever, frequent infections, or bleeding occur, a blood test should be performed. This medication can cause psychiatric symptoms such as aggression, agitation, anxiety, and depression, so if any unusual behavior appears, discuss with a healthcare professional. Seizures may worsen at the beginning of treatment or when the dose is increased; if this occurs, contact a physician immediately. Patients with heart conditions or an extended QT interval on an electrocardiogram should use caution. This medication generally has low drug interaction potential when used with other antiepileptic drugs; however, caution is advised when taken with methotrexate. Pregnant women or those planning to become pregnant should consult with healthcare professionals before taking this medication, as abrupt discontinuation may be risky. Women who are breastfeeding should consult healthcare professionals regarding the potential effects of this medication being passed into breast milk to the baby. For pediatric patients, safety in infants under 1 month of age has not been established, and children under 4 years should receive the liquid form. In elderly patients, the risk of side effects may be higher due to reduced kidney function, so dosage adjustments may be necessary. This medication can cause drowsiness or decreased concentration, so during the initial treatment or dosage adjustments, avoid driving or operating hazardous machinery. In case of overdose, symptoms such as vomiting, decreased consciousness, and respiratory depression may occur, and immediate emergency treatment is required. This medication should be kept out of reach of children, and it should not be transferred to another container.

• suicidal ideation
• suicidal behavior
• depression
• abnormal changes in mood and behavior
• drowsiness
• fatigue
• coordination movement disorder
• behavioral abnormalities
• weakness
• behavioral disorder

This medication should be stored in a tightly closed container to protect it from air and moisture. It is best to maintain a storage temperature between 1 to 30 degrees Celsius at room temperature.

Appearance

Blue oval film-coated tablets

Package unit

30 tablets/bottle, 120 tablets/bottle