Epileptam Injection (Levetiracetam)

Adult dosage

Levetiracetam treatment may be initiated by intravenous or oral administration. When switching from oral to intravenous administration, or vice versa, the dose may be given immediately without titration; the total daily dose and frequency of administration should remain the same. The injection is for intravenous administration only and must be diluted before use. 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. 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. After 2 weeks, increase 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 1. Partial-onset seizures Adults (18 years of age and older) and adolescents (16 years of age and older) Start this drug 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. 2. Myoclonic seizures in pediatric patients (16 years of age and older) Start this drug at 500mg 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. 3. 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) Start this drug 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. 4. Patients with renal impairment Since levetiracetam clearance is related to renal function, administer an individualized dose according to the patient's renal function. See the table below for dosage adjustments in adults. Normal (≥ 80 mL/min/1.73m2): 500-1,500mg, twice daily (at 12-hour intervals) Mild (50-79 mL/min/1.73m2): 500-1,000mg, twice daily (at 12-hour intervals) Moderate (30-49 mL/min/1.73m2): 250-750mg, twice daily (at 12-hour intervals) Severe (< 30 mL/min/1.73m2): 250-500mg, twice daily (at 12-hour intervals) End-stage renal disease patients on dialysis: 500-1,000mg, once daily (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. 5. Patients with hepatic impairment 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, if creatinine clearance is less than 60mL/min/1.73m2, it is recommended that the daily maintenance dose be reduced by 50%. 7. Elderly patients (65 years of age and older) Dosage adjustment is recommended in elderly patients with reduced renal function.

Children's dosage

Children and adolescents weighing less than 50kg with renal impairment Normal (≥ 80 ml/min/1.73m2): 10-30mg/kg twice daily Mild (50-79 ml/min/1.73m2): 10-20mg/kg twice daily Moderate (30-49 ml/min/1.73m2): 5-15mg/kg twice daily Severe (< 30 ml/min/1.73m2): 5-10 mg/kg twice daily End-stage renal disease patients on dialysis (--): 10-20mg/kg once daily (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 of age) ks= 0.55 (children and adolescent females under 13 years of age) ks= 0.7 (adolescent males) The injection is not recommended for children under 16 years of age because safety and efficacy have not been established. Tablets are not suitable for children under 4 years of age; infants 1 month of age and older should receive the oral solution. Oral formulations are not recommended for infants under 1 month of age because safety and efficacy data are insufficient.

This medication is used for treating epilepsy, and there may be an increased risk of suicidal thoughts or behaviors, as well as mental health issues such as depression during treatment. Therefore, it is important for patients and caregivers to report any symptoms immediately to the healthcare provider. This drug can cause central nervous system side effects such as drowsiness, fatigue, coordination problems, and behavioral abnormalities, especially within the first 4 weeks of treatment. Moreover, abrupt discontinuation of the drug can worsen seizures, so doses should be gradually reduced as directed by a physician. Patients with hypersensitivity or allergies to the active ingredient should not use this medication. Patients with suicidal thoughts or depression symptoms should be monitored more closely, and those on low-sodium diets should consider the sodium content of the drug. Patients with impaired kidney or liver function may require dose adjustments, so it is important to consult with a doctor. Blood-related abnormalities such as reduced blood cell counts can occur, so it is advisable to have blood tests if there are symptoms of fever or infection. This drug may induce psychiatric side effects such as irritability and aggression; if such symptoms arise, dosage adjustments or discontinuation should be considered. Seizures may worsen at the start of treatment or with dose escalation, so any symptoms should be discussed with a healthcare provider immediately. Patients with heart problems need to be cautious due to the risk of QT interval prolongation on an ECG. Drowsiness or dizziness may occur during treatment, so caution is needed when driving or operating machinery, especially during the initial treatment or when adjusting doses. In case of overdose, symptoms such as drowsiness, aggression, decreased consciousness, and respiratory depression may occur, requiring immediate medical attention. Use during pregnancy may affect the fetus, so women planning to become pregnant or who are pregnant must consult a doctor, and breastfeeding women should decide whether to continue breastfeeding since this drug can be excreted in breast milk and affect the baby. For infants under 1 month of age, safety has not been established, and children under 4 years of age should use the liquid formulation instead of tablets. Older adults may have a higher risk of adverse reactions due to impaired kidney function, so doses should be carefully adjusted. While this medication is relatively low in drug interactions with other antiepileptics, oral contraceptives, digoxin, and warfarin, careful monitoring of blood levels is required when used with methotrexate. Before administration, check for impurities or discoloration in the injection solution, and dispose of any unused portion as it is intended for single use. Lastly, this medication should be kept out of reach of children and should only be mixed with recommended solutions when diluted.

suicidal ideation, suicidal behavior, depression, abnormal changes in mood and behavior, drowsiness, fatigue, coordination disorder, behavioral abnormalities, weakness, aggression, anxiety, anger, emotional blunting, depersonalization, emotional instability, hostility, irritability, psychotic symptoms, hallucinations, psychosis, suicide attempt, suicidal thoughts, amnesia, inability to perform coordinated movements, attention deficit, memory impairment, hyperkinesia, insomnia, emotional instability, anxiety, personality disorder, abnormal thoughts, abdominal pain, diarrhea, dyspepsia, nausea, vomiting, loss of appetite, weight gain, dizziness, double vision, blurred vision, muscle pain, injury, nasopharyngitis, infection, cough, rash, eczema, pruritus, thrombocytopenia, chorea-acanthocytosis, dyskinesia, sensory disturbances, hypersomnia, gait disorder, worsening of seizures, psychotic disorders, abnormal behavior, confusional state, panic attacks, anger, delirium, obsessive-compulsive disorder, pancreatitis, liver failure, hepatitis, abnormal liver function test, weight loss, hyponatremia, toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, hair loss, muscle weakness, pancytopenia, agranulocytosis, leukopenia, neutropenia, eosinophilia, systemic symptoms, hypersensitivity reaction, angioedema, anaphylaxis, acute kidney injury, encephalopathy, neuroleptic malignant syndrome, QT prolongation on ECG, rhabdomyolysis, elevated serum CPK, hypotension, anxiety, altered consciousness, respiratory depression, coma, headache, tremors, balance disorders, seizures, loss of appetite, palpitations, aphasia, movement disorders, impulsive behavior, psychomotor retardation, edema, cheilitis, abdominal bloating, gastrointestinal disorders, hypersalivation, urticaria, sepsis, musculoskeletal rigidity, neck pain, polyuria, dyspnea

Store this medication in a sealed container to prevent contact with air, and keep it at room temperature, ideally between 1 to 30 degrees Celsius. Proper storage will maintain the drug's efficacy and prevent deterioration.

Appearance

A clear, colorless liquid in a glass vial injection

Package unit

5mL x 10 vials/box