Keppra Injection (Levetiracetam)

Adult dose

Levetiracetam treatment may be initiated by intravenous or oral administration. When changing the route of administration from oral to intravenous or vice versa, treatment may be continued immediately without dose titration, and the total daily dose and frequency of administration should remain the same. The injection is for intravenous administration only and must be diluted before administration. Dilute the dose in 100ml of a compatible diluent and infuse intravenously over 15 minutes. 250mg: 2.5ml (1/2 vial), 100ml, 15 minutes, twice daily, 500mg/day 500mg: 5ml (1 vial), 100ml, 15 minutes, twice daily, 1000mg/day 1000mg: 10ml (2 vials), 100ml, 15 minutes, twice daily, 2000mg/day 1500mg: 15ml (3 vials), 100ml, 15 minutes, twice daily, 3000mg/day There is no experience with intravenous administration of levetiracetam for more than 4 days. The 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 and administered twice daily. Monotherapy and adjunctive therapy for partial-onset seizures (16 years and older): Treatment with this drug is initiated at 500mg twice daily. However, based on the physician's assessment of potential adverse reactions relative to seizure reduction, the initial dose may be lowered to 250mg twice daily and increased to 500mg twice daily after 2 weeks. Depending on clinical response and tolerability, the dose may be increased or decreased every 2 to 4 weeks by 500mg/day [250mg per dose, twice daily] or 1000mg/day [500mg per dose, twice daily], and the maximum recommended dose is 3000mg/day [1500mg per dose, twice daily]. Adjunctive therapy for myoclonic seizures in pediatric patients (16 years and older): Treatment with this drug is initiated at 500mg twice daily. However, based on the physician's assessment of potential adverse reactions relative to seizure reduction, the initial dose may be lowered to 250mg twice daily and increased to 500mg twice daily after 2 weeks. Depending on clinical response and tolerability, the dose may be increased or decreased every 2 weeks by 500mg/day [250mg per dose, twice daily] or 1000mg/day [500mg per dose, twice daily], and the maximum recommended dose is 3000mg/day [1500mg per dose, twice daily]. Efficacy has not been studied at doses below 3,000mg/day. Adjunctive therapy for primary generalized tonic-clonic seizures (16 years and older): Treatment with this drug is initiated at 1,000mg/day [500mg per dose, twice daily]. However, based on the physician's assessment of potential adverse reactions relative to seizure reduction, the initial dose may be lowered to 250mg twice daily and increased to 500mg twice daily after 2 weeks. Depending on clinical response and tolerability, the dose may be increased or decreased every 2 weeks by 500mg/day [250mg per dose, twice daily] or 1000mg/day [500mg per dose, twice daily], and the maximum recommended dose is 3000mg/day [1500mg per dose, twice daily]. Efficacy has not been adequately studied at doses below 3,000mg/day. Adult patients with renal impairment: Normal (≧ 80): 500-1,500mg, twice daily (12-hour intervals) Adult patients with renal impairment: Mild (50-79): 500-1,000mg, twice daily (12-hour intervals) Adult patients with renal impairment: Moderate (30-49): 250-750mg, twice daily (12-hour intervals) Adult patients with renal impairment: Severe (< 30): 250-500mg, twice daily (12-hour intervals) Adult patients with renal impairment: End-stage renal disease patients on dialysis (1)(-): 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, if 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

Pediatric patients and adolescents weighing less than 50 kg with renal impairment: Normal (≧ 80): 10-30mg/kg twice daily Pediatric patients and adolescents weighing less than 50 kg with renal impairment: Mild (50-79): 10-20mg/kg twice daily Pediatric patients and adolescents weighing less than 50 kg with renal impairment: Moderate (30-49): 5-15mg/kg twice daily Pediatric patients and adolescents weighing less than 50 kg with renal impairment: Severe (< 30): 5-10 mg/kg twice daily Pediatric patients and adolescents weighing less than 50 kg with renal impairment: End-stage renal disease patients on dialysis (--): 10-20mg/kg once daily(1)(2) (1) A loading dose of 15mg/kg is recommended on the first day of treatment. (2) An additional dose of 5-10mg/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) Injection is not recommended for 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 or younger; infants aged 1 month or older should be given the liquid formulation. The oral formulation is not recommended for infants under 1 month of age because of insufficient safety and efficacy data.

This medication may increase the risk of suicidal thoughts or behavior, so close observation for depression, mood changes, or unusual behavior should be carried out during treatment. It can affect the central nervous system, potentially causing drowsiness, fatigue, coordination problems, or behavioral abnormalities, especially within the first 4 weeks of starting the medication. Sudden discontinuation can worsen seizures, so the dosage should be gradually tapered as directed by a physician. It should not be used if there is hypersensitivity to this medication or an allergy to the active ingredient. If there are thoughts of suicide or symptoms of depression, inform a doctor immediately, and patients on a low-sodium diet should consider the sodium content in the medication. Patients with impaired kidney or liver function may require dosage adjustments, and regular blood tests to check white blood cell counts are recommended. This medication may provoke psychiatric symptoms such as irritability and aggression, so consultation with a physician is necessary if unusual behaviors are observed. Caution is advised as seizures may worsen at the beginning of therapy or during dosage increases, and patients with heart disease or those at risk of QT interval prolongation may require an ECG. Side effects such as drowsiness, headache, dizziness, insomnia, depression, loss of appetite, abdominal pain, and rash may occur, and in rare cases, severe skin reactions or blood abnormalities may arise. During pregnancy, careful use is recommended considering the potential impact on the fetus, and during breastfeeding, the medication can be transmitted through breast milk, so nursing should be reconsidered or stopped. Particular caution regarding dosage and safety is needed for children and the elderly, and injection use in infants under 1 month or children under 16 years has not been established for safety. Drowsiness or decreased concentration may occur while driving or operating machinery, so caution is necessary. In case of overdose, the medication can be eliminated by vomiting or gastric lavage, and blood dialysis may be performed if needed. This medication does not have significant drug interactions with other antiepileptic drugs, oral contraceptives, warfarin, or digoxin, but care should be taken with increased blood concentrations when used in conjunction with methotrexate. When storing the medication, keep it in a sealed container out of the reach of children, do not use products that are discolored or contain foreign substances, and dispose of any remaining medication after use.

• suicidal impulses
• suicidal behavior
• depression
• abnormal changes in mood and behavior
• drowsiness
• fatigue
• coordination disorders
• behavior abnormalities
• lethargy
• behavioral disorders

This medication should be stored in a sealed container to prevent exposure to air, and the storage temperature should be maintained between 1 to 30 degrees Celsius at room temperature. This helps in maintaining the efficacy of the drug.

Appearance

A clear, colorless liquid in a glass vial for injection

Package unit

5mL * 10 Vial/Box