Donggu Levetiracetam Tablet 1000mg

Adult dose

Film-coated tablets and oral solution are administered orally, may be taken with or without food, and should be taken with a sufficient amount of water. The total daily dose is divided into 2 equal doses and administered twice daily. 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 switched directly without dose titration; the total daily dose and frequency of administration should remain the same. Monotherapy — Adults and adolescents aged 16 years and older: The initial dose is 250mg twice daily. After 2 weeks, increase the dose to 500mg twice daily. Depending on the 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 — Partial-onset seizures, adults (18 years and older) and adolescents weighing 50kg or more (12~17 years): Start this medication 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 — Primary generalized tonic-clonic seizures (12 years and older), adults (18 years and older) and adolescents weighing 50kg or more (12-17 years): 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 has not been adequately studied at doses below 3,000mg/day. Adult patients with renal impairment — Normal (≧ 80): 500-1,500mg per dose, twice daily (12-hour intervals) Adult patients with renal impairment — Mild (50-79): 500-1,000mg per dose, twice daily (12-hour intervals) Adult patients with renal impairment — Moderate (30-49): 250-750mg per dose, twice daily (12-hour intervals) Adult patients with renal impairment — Severe (< 30): 250-500mg per dose, twice daily (12-hour intervals) Adult patients with renal impairment — End-stage renal disease patients 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 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, it is recommended that the daily maintenance dose be reduced by 50%. Older adults (65 years and older): Dose adjustment is recommended in older patients with reduced renal function.

Child dose

Partial-onset seizures — Children aged 4 years to 11 years and adolescents aged 12~17 years weighing less than 50kg: Start with an initial dose of 10mg/kg per dose, twice daily. Depending on clinical response and tolerability, the dose may be increased 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 — 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] Partial-onset seizures — 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] Partial-onset seizures — 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 twice daily. Increase the dose by 1,000mg/day every 2 weeks to the recommended daily dose of 3,000mg. Efficacy has not been studied at doses below 3,000mg/day. 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 has not been adequately studied at doses below 60mg/kg/day. Pediatric patients and adolescents weighing less than 50kg with renal impairment — Normal (≧ 80): 10-30mg/kg (0.10-0.30 ml/kg) twice daily Pediatric patients and adolescents weighing less than 50kg with renal impairment — Mild (50-79): 10-20mg/kg (0.10-0.20 ml/kg) twice daily Pediatric patients and adolescents weighing less than 50kg with renal impairment — Moderate (30-49): 5-15mg/kg (0.05-0.15ml/kg) twice daily Pediatric patients and adolescents weighing less than 50kg with renal impairment — Severe (< 30): 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 (--): 10-20mg/kg (0.10-0.20 ml/kg) once daily(1)(2) (1) A loading dose of 15 mg/kg (0.15ml/kg) is recommended on the first day of treatment. (2) An additional dose of 5-10 mg/kg (0.05-0.10ml/kg) is recommended after dialysis. ks= 0.45 (infants under 1 year) ks= 0.55 (children under 13 years and female adolescents) ks= 0.7 (male adolescents) Pediatric patients: The oral formulation is not recommended for infants under 1 month of age due to insufficient safety and efficacy data. Tablets are not suitable for children 4 years and younger; the oral solution should be administered to infants 1 month and older. The injectable formulation is not recommended for children under 16 years of age because its safety and efficacy have not been established.

This medication is used for the treatment of epilepsy, and the risk of suicidal thoughts or behaviors may increase during treatment; therefore, patients and caregivers should immediately inform healthcare providers of any mood changes or depressive symptoms. Since it affects the central nervous system, symptoms such as drowsiness, fatigue, coordination difficulties, and behavioral abnormalities may occur, so caution is advised when initiating therapy or adjusting doses. Due to the nature of antiepileptic drugs, abrupt discontinuation may increase the frequency of seizures, so the medication should be discontinued gradually under a physician's guidance. Individuals allergic to any ingredients in this medication should not take it, and dosage adjustment may be necessary for patients with impaired kidney function. This medication can cause psychiatric adverse reactions such as behavioral changes, aggression, depression, or suicidal thoughts, so healthcare consultation should be sought immediately if these symptoms arise. Patients with heart disease or prolonged QT intervals should be closely monitored for cardiac status while taking this medication. Women who are pregnant or planning to become pregnant should consult healthcare providers about the use of this medication, and breastfeeding mothers may need to halt nursing or reevaluate medication intake, as the drug may be transmitted through breast milk. For children, safety has not been established in infants less than 1 month old, and liquid formulations should be used instead of tablets for children under 4 years old. Elderly patients may have impaired kidney function, so cautious dosage determination is necessary, and central nervous system symptoms such as drowsiness or dizziness can occur at the beginning of treatment or during dose escalation, so care should be taken when driving or operating machinery. In cases of overdose, measures should be taken to reduce drug absorption by inducing vomiting or gastric lavage, and blood dialysis may be helpful, so it is essential to visit a medical institution immediately. This medication has relatively few drug interactions with other antiepileptic drugs, oral contraceptives, and anticoagulants; however, caution is advised with specific medications, so healthcare providers should be informed of any concurrent medications. When taking this medication, store it out of reach of children and do not transfer it to another container for safety.

Suicidal ideation, suicidal behavior, depression, abnormal changes in mood and behavior, drowsiness, fatigue, psychomotor agitation, behavioral abnormalities, asthenia, behavioral disorders, aggression, restlessness, anger, anxiety, emotional numbness, depersonalization, emotional instability, hostility, irritability, psychotic symptoms, hallucinations, psychosis, adverse reactions related to psychosis, suicide attempt, suicidal thoughts, aggressiveness, nervousness, hyperkinesia, neurosis, personality disorders, abnormal thought, abdominal pain, diarrhea, dyspepsia, nausea, vomiting, loss of appetite, weight gain, dizziness, diplopia, blurred vision, myalgia, injury, nasopharyngitis, infection, cough, rash, eczema, pruritus, thrombocytopenia, chorea-acanthocytosis, dyskinesia, sensory disturbances, hypersomnia, gait disturbance, exacerbation of seizures, psychotic disorder, abnormal behavior, confusion, panic attacks, anger, delirium, obsessive-compulsive disorder, pancreatitis, hepatic 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, drug reactions accompanied by eosinophilia and systemic symptoms, hypersensitivity reactions, angioedema, anaphylaxis, acute kidney injury, encephalopathy, neuroleptic malignant syndrome, QT interval prolongation in electrocardiogram, rhabdomyolysis, obsessive-compulsive disorder, restlessness, loss of appetite, headache, tremor, balance disorder, memory loss, coordination failure, attention deficit, memory impairment, hyperkinesia, insomnia, emotional instability, restlessness, personality disorders, abnormal thought, psychotic depression, psychotic adverse reactions, psychotic behavioral disorder, delusional behavior, auditory hallucinations, suicidal thoughts, exacerbation of schizophrenia, suicide, suicide attempt, suicidal ideation, hallucinations, confusion, panic attacks, anxiety, anger, delirium, obsessive-compulsive disorder, constipation, palpitations, aphasia, movement disorders, impulsive behavior, psychomotor retardation, edema, cheilitis, abdominal distension, hypersalivation, urticaria, sepsis, musculoskeletal rigidity, neck pain, frequent urination, dyspnea, drowsiness, restlessness, aggressiveness, decreased consciousness, respiratory depression, coma

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is advisable to maintain room temperature between 1 degree and 30 degrees Celsius. Proper storage can help maintain the medication's efficacy and safety over time.

Appearance

White oval film-coated tablet

Package unit

30 tablets/bottle