Staletam 500 mg (Levetiracetam)

Adult dose

Film-coated tablets and oral solution are administered orally and may be taken with or without food, with plenty 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 change may be made directly without dose titration; the total daily dose and frequency of administration should remain the same. Monotherapy Adults and 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 per dose, twice daily]. Adjunctive therapy Adults with partial-onset seizures (18 years of age 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/day [500mg per dose, twice daily] every 2 to 4 weeks; the maximum recommended dose is 3000mg/day. Patients with renal impairment: Since 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. Dose adjustment for 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. 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, a 50% reduction in the daily maintenance dose is recommended. Older adults (65 years of age and older): Dose adjustment is recommended in elderly patients with impaired renal function.

Child dose

Partial-onset seizures, children aged 4 to 11 years: The initial dose is 10mg/kg per dose, twice daily. Depending on clinical response and tolerability, the dose may be increased up to 60mg/kg/day [30mg/kg per dose, twice daily]. Dose changes should not exceed an increase or decrease of 20mg/kg/day [10mg/kg per dose, twice daily] every 2 weeks. Use the lowest effective dose. Partial-onset seizures, adolescents aged 12 to 17 years weighing less than 50kg: The initial dose is 10mg/kg per dose, twice daily. Depending on clinical response and tolerability, the dose may be increased up to 60mg/kg/day [30mg/kg per dose, twice daily]. Dose changes should not exceed an increase or decrease of 20mg/kg/day [10mg/kg per dose, twice daily] every 2 weeks. Use the lowest effective dose. Partial-onset seizures, children weighing 50kg or more: The dose for children weighing 50kg or more is the same as the adult dose. Partial-onset seizures, adolescents aged 12 to 17 years weighing 50kg or more: Start this medication at 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. 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] 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] 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. Myoclonic seizures in pediatric patients (12 years and older): Start this medication at 500mg per dose, 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. Primary generalized tonic-clonic seizures (12 years and older), adolescents aged 12-17 years weighing 50kg or more: Start this medication at 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. Primary generalized tonic-clonic seizures (12 years and older), adolescents aged 12-17 years weighing less than 50kg: Start this medication at 20mg/kg/day [10mg/kg per dose, twice daily]. Increase the dose by 20mg/kg/day [10mg/kg per dose, twice daily] every 2 weeks 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 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) twice daily Pediatric patients and adolescents weighing less than 50kg with renal impairment: Mild, creatinine clearance 50-79 (ml/min/1.73m2): 10-20mg/kg(0.10-0.20 ml/kg) twice daily Pediatric patients and adolescents weighing less than 50kg with renal impairment: Moderate, creatinine clearance 30-49 (ml/min/1.73m2): 5-15mg/kg (0.05-0.15ml/kg) twice daily Pediatric patients and adolescents weighing less than 50kg with renal impairment: Severe, creatinine clearance < 30 (ml/min/1.73m2): 5-10 mg/kg (0.05-0.10ml/kg) twice daily Pediatric patients and adolescents weighing less than 50kg with renal impairment: 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) ; ks= 0.55 (children and adolescent females under 13 years) ks= 0.7 (adolescent males) Oral formulations are not recommended for infants younger than 1 month because of insufficient safety and efficacy data. Tablets are not indicated for children aged 4 years or younger; infants aged 1 month or older should receive the oral solution. Use of the injection is not recommended in children younger than 16 years because its safety and efficacy have not been established.

This drug is used to treat epilepsy and may increase the risk of suicidal thoughts or behaviors during use; therefore, patients and caregivers should immediately inform healthcare professionals of any changes in mood or unusual behaviors. This medication can cause neurological and psychiatric side effects such as drowsiness, fatigue, coordination disorders, and behavioral abnormalities, especially within the first 4 weeks of treatment. Abrupt cessation of this drug may increase the risk of seizures, so the dosage must be gradually reduced according to a doctor's instructions. Patients with allergies to any of the ingredients in this medication should not take it, and those with impaired kidney function may require dosage adjustments. Symptoms such as decreased blood cell counts, abnormal behaviors, aggression, and hyperexcitability may occur; consult a doctor if such symptoms are present. Patients with heart conditions or at risk for QT interval prolongation should use caution when administering this drug. Women who are pregnant or planning to become pregnant should consult with healthcare professionals regarding the use of this medication, and breastfeeding mothers may need to decide whether to discontinue nursing or the medication, as it can be passed through breast milk. The safety of this medication has not been established in infants, especially those under 1 month of age, and children under 4 years should be treated with liquid formulations. Elderly patients may have an increased risk of side effects due to decreased kidney function, so dosage adjustments should be made carefully. Drowsiness or decreased concentration may occur with this drug, so caution is required when driving or operating machinery. In cases of overdose, symptoms may include drowsiness, agitation, aggression, and decreased consciousness; since there is no specific antidote, immediate medical attention should be sought for appropriate treatment. This medication does not have significant drug interactions with other antiepileptic drugs or oral contraceptives, but caution is needed when used with certain medications, so all concurrent medications should be disclosed to healthcare providers. If symptoms such as rash, fever, or swollen lymph nodes occur during treatment, this could indicate a serious allergic reaction and healthcare providers should be notified immediately.

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

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

Appearance

Yellow oval film-coated tablet

Package unit

30 tablets/bottle, 120 tablets/bottle