Retiram Tablets 500mg (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 and adolescents 16 years and older: 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, myoclonic seizures in pediatric patients (12 years and older): Start treatment with 500mg per dose twice daily. Increase the dose by 1,000mg/day every 2 weeks up to the recommended daily dose of 3,000mg. Efficacy has not been studied at doses below 3,000mg/day. Adjunctive therapy, primary generalized tonic-clonic seizures (12 years and older), 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. Dose adjustment for adult patients with renal impairment Normal, creatinine clearance ≥ 80 (mL/min/1.73m2): Dose per administration 500-1,500mg, twice daily (12-hour intervals) Mild, creatinine clearance 50-79 (mL/min/1.73m2): Dose per administration 500-1,000mg, twice daily (12-hour intervals) Moderate, creatinine clearance 30-49 (mL/min/1.73m2): Dose per administration 250-750mg, twice daily (12-hour intervals) Severe, creatinine clearance < 30 (mL/min/1.73m2): Dose per administration 250-500mg, twice daily (12-hour intervals) 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. 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 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

Partial-onset seizures, children aged 4 years to 11 years and adolescents aged 12-17 years weighing less than 50kg: 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/day [30mg/kg per dose, 2 times daily]. Dose changes should not exceed increases or decreases of 20mg/kg/day [10mg/kg per dose, 2 times 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, body weight 15-20kg(1): 20mg/kg/day(2 times daily) 300mg-400mg/day [150-200mg per dose, 2 times daily]; 40mg/kg/day(2 times daily) 600mg-800mg/day [300-400mg per dose, 2 times daily]; 60mg/kg/day(2 times daily) 900mg-1,200mg/day [450-600mg per dose, 2 times daily] Recommended dose for partial-onset seizures, body weight 20.1-40kg: 20mg/kg/day(2 times daily) 500mg/day [250mg per dose, 2 times daily]; 40mg/kg/day(2 times daily) 1,000mg/day [500mg per dose, 2 times daily]; 60mg/kg/day(2 times daily) 1,500mg/day [750mg per dose, 2 times daily] Recommended dose for partial-onset seizures, body weight 40.1-50kg(2): 20mg/kg/day(2 times daily) 1,000mg/day [500mg per dose, 2 times daily]; 40mg/kg/day(2 times daily) 2,000mg/day [1,000mg per dose, 2 times daily]; 60mg/kg/day(2 times daily) 3,000mg/day [1,500mg per dose, 2 times 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. Primary generalized tonic-clonic seizures (12 years and older), adolescents aged 12-17 years weighing 50kg or more: Start treatment with this drug at 1,000mg/day [500mg per dose, 2 times daily]. Increase the dose by 1,000mg/day [500mg per dose, 2 times daily] every 2 weeks up to the recommended daily dose of 3,000mg [1,500mg per dose, 2 times daily]. Efficacy at doses below 3,000mg/day has not been adequately studied. Primary generalized tonic-clonic seizures (12 years and older), adolescents aged 12-17 years weighing less than 50kg: Start treatment with this drug at 20mg/kg/day [10mg/kg per dose, 2 times daily]. Increase the dose by 20mg/kg/day [10mg/kg per dose, 2 times daily] every 2 weeks up to the recommended daily dose of 60mg/kg [30mg/kg per dose, 2 times daily]. Efficacy at doses below 60mg/kg/day has not been adequately studied. Dose adjustment in pediatric patients and adolescent patients weighing less than 50kg with renal impairment Normal, creatinine clearance ≥ 80 (ml/min/1.73m2): 10-30mg/kg(0.10-0.30 ml/kg) 2 times daily Mild, creatinine clearance 50-79 (ml/min/1.73m2): 10-20mg/kg(0.10-0.20 ml/kg) 2 times daily Moderate, creatinine clearance 30-49 (ml/min/1.73m2): 5-15mg/kg (0.05-0.15ml/kg) 2 times daily Severe, creatinine clearance < 30 (ml/min/1.73m2): 5-10 mg/kg (0.05-0.10ml/kg) 2 times daily 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 younger than 1 year) ; ks= 0.55 (female children and adolescents younger than 13 years) ks= 0.7 (adolescent males) The oral formulation is not recommended for infants younger than 1 month because of insufficient safety and efficacy data. Tablet administration is not applicable to children 4 years and younger; the solution should be administered to infants 1 month and older. Administration of the injection is not recommended in children younger than 16 years because its safety and efficacy have not been established.

This medication is used to treat epilepsy, which may increase the risk of developing mental health issues such as suicidal thoughts or behaviors, and depression during treatment. Therefore, patients and caregivers should closely monitor for any changes in mood or behavior, and it is important to inform healthcare providers immediately if abnormal symptoms appear. This medication may cause central nervous system side effects such as drowsiness, fatigue, coordination disorders, and behavioral abnormalities, especially within the first four weeks of treatment. Drowsiness, fatigue, and behavioral abnormalities have also been reported in pediatric patients. Discontinuing the medication abruptly may worsen seizures, thus it is essential to gradually reduce the dosage as directed by a physician. Patients with hypersensitivity to the components of this medication or similar drugs should not take it. Patients with suicidal thoughts or symptoms of depression, compromised renal function, decreased blood cell count, and psychiatric symptoms should use this medication with caution. Additionally, there is the possibility of exacerbation of seizures, so immediate consultation with a physician is necessary if symptoms occur. Patients with heart disease or electrolyte imbalance should pay attention to cardiovascular side effects such as QT interval prolongation on ECG while taking this medication. Women who are pregnant or planning to become pregnant must discuss the use of this medication with their healthcare providers, and nursing mothers should stop breastfeeding or reconsider the use of this medication as it may pass through the breast milk to the infant. The safety of this medication has not been established in children, especially infants under 1 month old, and children under 4 years old should be treated with a liquid form. Elderly patients may require dosage adjustments due to an increased risk of side effects related to decreased renal function. Caution should be exercised when performing hazardous tasks like driving or operating machinery as drowsiness or decreased concentration may occur. In case of overdose, symptoms may include drowsiness, aggression, reduced consciousness, etc., and immediate medical treatment is required as there is no specific antidote available. This medication generally has low interactions with other drugs; however, caution is advised as it may increase blood levels when used in combination with methotrexate. Monitor for side effects and symptoms closely during treatment, and report any unusual symptoms to healthcare providers immediately for safety.

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

This medication should be stored in a closed container to protect it from air and moisture, and it is recommended to store at room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the medication's efficacy and prevent degradation.

Appearance

Yellow oval film-coated tablet

Package unit

30 tablets/bottle, 120 tablets/bottle