Levetiracetam Injection 1000mg (Levetiracetam)

Adult dose

Levetiracetam treatment may be initiated by intravenous or oral administration. When switching the route of administration from oral to intravenous or vice versa, the switch may be made directly without dose titration, and the total daily dose and frequency of administration should remain the same. The injection is administered intravenously only, by infusion over 15 minutes. There is no experience with intravenous administration of levetiracetam for more than 4 days. The daily dose should be divided into 2 equal doses administered twice daily. The premixed formulation* should be used only when one bag per dose can replace the applicable dose for monotherapy or adjunctive therapy; it should not be divided into smaller portions. *Premixed formulations: JW Life Science - Levetiram Injection 500mg (levetiracetam 500mg/1 bag), Levetiram Injection 1000mg (levetiracetam 1000mg/1 bag) 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, up to a maximum dose of 3000mg/day [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) Treatment with this drug 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. Adjunctive therapy - Myoclonic seizures in pediatric patients (16 years of age and older) Treatment with this drug is initiated at 500mg twice daily. The dose is increased 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. 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) Treatment with this drug is initiated at 1,000mg/day [500mg per dose, twice daily]. The dose is increased 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. Dose adjustment for adult patients with renal impairment 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(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, 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 elderly patients with reduced renal function.

Child dose

Dosage adjustment in pediatric patients and adolescent patients weighing <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)(2) (1) A loading dose of 15mg/kg is recommended on the first day of treatment. (2) After dialysis, an additional dose of 5-10mg/kg is recommended. ks= 0.45 (infants under 1 year) ks= 0.55 (children and adolescent females under 13 years) The injectable formulation is not recommended for children under 16 years of age because its safety and efficacy have not been established. Tablets are not applicable for children 4 years of age or younger, and the oral solution should be administered to infants aged 1 month or older. Oral formulations are not recommended for infants under 1 month of age because of insufficient safety and efficacy data.

This medication is used for the treatment of epilepsy and may increase the risk of suicide ideation, suicidal behavior, and mental health issues such as depression during treatment. Therefore, patients receiving treatment should be closely monitored for these symptoms or changes in mood and behavior. This medication can cause central nervous system side effects such as drowsiness, fatigue, coordination disorders, and behavioral changes, particularly within the first four weeks of treatment. If the medication is suddenly discontinued, seizures may worsen, so the dose should be gradually reduced according to the doctor's instructions. Patients with allergies to the active ingredient or components of this medication should not use it. Patients with suicidal thoughts or depressive symptoms should consult a physician, and patients on a low-sodium diet should consider the sodium content in this medication. Patients with poor kidney function may need dose adjustment, and those with severely impaired liver function should undergo kidney function tests first. As blood cell counts may decrease, blood tests are recommended if symptoms of fatigue, fever, or infection occur. This medication can cause behavioral disorders such as aggression, irritability, and anxiety; therefore, if psychiatric symptoms arise, consider adjusting or discontinuing the medication. Seizures may worsen at the beginning of treatment or with dose increases, so if symptoms appear, consult a physician immediately. Patients with heart disease or a risk of prolonged QT interval on an ECG should be cautious. The effects of this medication on the fetus during pregnancy are not fully understood, so it should only be used at the minimum dose when absolutely necessary, and while breastfeeding, one should consider stopping breastfeeding or making careful decisions regarding medication administration due to potential transmission through breast milk. The safety in infants under 1 month has not been established, and children under 4 years should use the liquid formulation instead of tablets. Elderly patients may face an increased risk of side effects due to decreased kidney function, so dose adjustment may be necessary. Caution should be taken when driving or operating machinery, as drowsiness or dizziness may occur. In case of overdose, symptoms such as drowsiness, agitation, decreased consciousness, and respiratory depression may arise, and the drug should be removed through vomiting or gastric lavage, and blood dialysis should be performed if necessary. This medication does not interact significantly with other antiepileptic medications, oral contraceptives, digoxin, or warfarin. If any unusual behavior, psychiatric symptoms, blood abnormalities, skin rashes, etc., occur during medication, consult a physician immediately.

suicidal thoughts, suicidal behavior, depression, drowsiness, fatigue, cooperative movement disorder, behavioral abnormality, weakness, aggression, anxiety, anger, emotional blunting, depersonalization, emotional instability, hostility, irritability, psychotic symptoms, hallucinations, psychosis, suicide attempt, suicidal ideation, amnesia, inability to perform coordinated movements, ataxia, attention deficit, memory impairment, hyperkinesia, insomnia, emotional instability, anxiety, personality disorder, abdominal pain, diarrhea, indigestion, nausea, vomiting, loss of appetite, weight gain, dizziness, double vision, blurred vision, myalgia, injury, nasopharyngitis, infection, coughing, rash, eczema, pruritus, thrombocytopenia, chorea-acanthocytosis, dyskinesia, sensory disturbances, hypersomnia, gait disturbance, exacerbation of seizures, psychotic disorder, abnormal behavior, confusional state, panic attack, anger, delirium, obsessive-compulsive disorder, pancreatitis, liver failure, hepatitis, abnormal liver function tests, weight loss, hyponatremia, toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, hair loss, muscle weakness, pancytopenia, agranulocytosis, leukopenia, neutropenia, eosinophilia, drug reactions with systemic symptoms, hypersensitivity reaction, angioedema, anaphylaxis, acute kidney injury, encephalopathy, neuroleptic malignant syndrome, QT interval prolongation, rhabdomyolysis, increased serum CPK, hypotension, drowsiness, anxiety, aggression, decreased consciousness, respiratory depression, coma, constipation, palpitations, aphasia, movement disorders, impulsive behavior, psychomotor retardation, edema, cheilitis, abdominal distension, increased salivation, urticaria, sepsis, musculoskeletal rigidity, cervical pain, increased urinary frequency, dyspnea

This medication should be stored in a sealed container to prevent air or moisture from entering, at room temperature between 1 degree Celsius and 30 degrees Celsius. Proper storage will help maintain the drug's effectiveness for a longer time.

Appearance

A clear, colorless solution filled in a colorless, transparent plastic container for injections.

Package unit

110mL