Keratum Injection 100mg/mL (Levetiracetam)

Adult dosage

Levetiracetam treatment may be initiated by intravenous or oral administration. When changing the route of administration from oral to intravenous or vice versa, the same dose may be administered directly without dose titration; the total daily dose and frequency of administration should remain the same. The injection is for intravenous use only and must be diluted before administration. Dilute the dose in 100mL of a compatible diluent and infuse intravenously over 15 minutes. 250mg: Dose 2.5mL, diluent volume 100mL, infusion time 15 minutes, frequency 2 times daily, total daily dose 500mg/day 500mg: Dose 5mL, diluent volume 100mL, infusion time 15 minutes, frequency 2 times daily, total daily dose 1000mg/day 1000mg: Dose 10mL, diluent volume 100mL, infusion time 15 minutes, frequency 2 times daily, total daily dose 2000mg/day 1500mg: Dose 15mL, diluent volume 100mL, infusion time 15 minutes, frequency 2 times daily, total daily dose 3000mg/day There is no experience with intravenous administration of levetiracetam for more than 4 days. 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 administered twice daily. Monotherapy, adults and adolescents 16 years of age and older: The initial dose is 250mg twice daily, increased after 2 weeks to 500mg twice daily. Depending on the clinical response, the dose may be increased every 2 weeks by 500mg daily [250mg per dose, twice daily]; the maximum dose is 3000mg daily [1500mg per dose, twice daily]. Adjunctive therapy, partial-onset seizures, adults (18 years of age and older) and adolescents (16 years of age and older): Initiate treatment with 500mg twice daily. Depending on clinical response and tolerability, the dose may be increased or decreased every 2 to 4 weeks by 1000mg daily [500mg per dose, twice daily]; the maximum recommended dose is 3000mg daily. Adjunctive therapy, myoclonic seizures in pediatric patients (16 years of age and older): Initiate treatment with 500mg twice daily. Increase the dose by 1,000mg daily every 2 weeks to the recommended daily dose of 3,000mg. Efficacy at doses below 3,000mg daily has not been studied. Adjunctive therapy, primary generalized tonic-clonic seizures (16 years of age and older), adults (18 years of age and older) and adolescents (16 years of age and older): Initiate treatment with 1,000mg daily [500mg per dose, twice daily]. Increase the dose every 2 weeks by 1,000mg daily [500mg per dose, twice daily] to the recommended daily dose of 3,000mg [1,500mg per dose, twice daily]. Efficacy at doses below 3,000mg daily has not been adequately studied. Patients with renal impairment: Since levetiracetam clearance is related to renal function, administer the dose individually according to the patient's renal function. Adult patients with renal impairment, normal, > 80 mL/min/1.73m2: 500-1,500mg per dose, 2 times daily (12-hour interval) Adult patients with renal impairment, mild, 50-79 mL/min/1.73m2: 500-1,000mg per dose, 2 times daily (12-hour interval) Adult patients with renal impairment, moderate, 30-49 mL/min/1.73m2: 250-750mg per dose, 2 times daily (12-hour interval) Adult patients with renal impairment, severe, < 30 mL/min/1.73m2: 250-500mg per dose, 2 times daily (12-hour interval) Adult patients with renal impairment, end-stage renal disease on dialysis(1), -: 500-1,000mg per dose, once daily(2) (1) An initial loading dose of 750mg is recommended on the first day of administration. (2) An additional dose of 250-500mg is recommended after dialysis. No dosage 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 recommended that the daily maintenance dose be reduced by 50%. Older adults (65 years of age and older): Dose adjustment is recommended in older patients with reduced renal function.

Children's dosage

ks= 0.45 (infants under 1 year of age) ks= 0.55 (children and female adolescents under 13 years of age) ks= 0.7 (male adolescents) Children and adolescents weighing less than 50kg with renal impairment, normal, > 80 ml/min/1.73m2: 10-30mg/kg twice daily Children and adolescents weighing less than 50kg with renal impairment, mild, 50-79 ml/min/1.73m2: 10-20mg/kg twice daily Children and adolescents weighing less than 50kg with renal impairment, moderate, 30-49 ml/min/1.73m2: 5-15mg/kg twice daily Children and adolescents weighing less than 50kg with renal impairment, severe, < 30 ml/min/1.73m2: 5-10 mg/kg twice daily Children and adolescents weighing less than 50kg with renal impairment, end-stage renal disease on dialysis, --: 10-20mg/kg once daily(1)(2) (1) A loading dose of 15mg/kg is recommended on the first day of administration. (2) An additional dose of 5-10mg/kg is recommended after dialysis. Use of the injection is not recommended in children under 16 years of age because its safety and efficacy have not been established. Tablet administration is not applicable to children 4 years of age and younger; the oral solution should be administered to infants 1 month of age and older. Oral formulations are not recommended for infants under 1 month of age because safety and efficacy data are insufficient.

This medication is used to control seizures in patients with epilepsy. During treatment, there is a risk of developing psychiatric issues such as suicidal thoughts, suicidal behavior, or depression, so patients or caregivers should monitor for these symptoms closely. This medication can cause central nervous system side effects such as drowsiness, fatigue, coordination disorders, and behavioral abnormalities, especially within the first 4 weeks of treatment. Stopping the medication suddenly can worsen seizures, so the dosage should be gradually reduced. Patients allergic to this medication or its components should not use it. Psychiatric adverse reactions, such as aggression, agitation, anxiety, depression, and suicidal thoughts, may occur, and if any symptoms arise, immediate consultation with a physician is necessary. Patients with decreased kidney function may require dose adjustments, and those with severe liver dysfunction are recommended to undergo kidney function tests before administration. This drug can cause a decrease in blood cell count, so blood tests should be conducted if fever or infection symptoms occur. Patients with cardiac disease or those with prolonged QT intervals on electrocardiograms should use this medication cautiously. Women who are pregnant or planning to become pregnant should discuss the use of this medication with their doctors thoroughly, and nursing mothers should consider discontinuing nursing or the medication due to potential adverse effects on the infant from drug transmission through breast milk. When administered to children or the elderly, the safety and efficacy should be carefully evaluated, and especially in children, the liquid formulation should be used from one month of age onward, while injections are not recommended for those under 16 years of age. Caution is needed when performing tasks requiring concentration, such as driving or operating machinery, as drowsiness or fatigue may occur. In the case of overdose, symptoms such as drowsiness, decreased consciousness, and respiratory depression may appear, and emergency treatment should be sought immediately. This medication has relatively few drug interactions when used with other antiepileptic medications or oral contraceptives, but when used with certain drugs, it is necessary to monitor blood concentrations carefully.

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

This medication should be stored in a sealed container to prevent air or moisture infiltration, and it is recommended to keep it at room temperature between 1 and 30 degrees Celsius. Storing it this way will maintain the drug's effectiveness for a longer period.

Appearance

A glass vial injection containing a colorless and transparent solution

Package unit

5mL/vial X 10, 10mL/vial X 10