Levetiracetam Tablets.

Effects and efficacy: Tablets: used for the treatment of partial seizures (with or without secondary generalized seizures) in adults and children over 4 years of age with epilepsy; used as an adjunctive treatment for generalized tonic-clonic seizures in adults and adolescents over 16 years of age with epilepsy. Sustained-release tablets: used as an adjunctive treatment for partial seizures in patients with epilepsy aged 12 years and above. Oral solution: used as an adjunctive treatment for partial seizures in adults, children and infants over 1 month of age with epilepsy. Concentrated solution for injection: used as an adjunctive treatment for partial seizures (with or without secondary generalized seizures) in adults and children over 4 years of age with epilepsy.
Dosage and administration: Adults (>18 years of age) and adolescents (12-17 years of age) weighing ≥50kg: The initial treatment dose is 500mg each time, twice a day. Depending on the clinical effect and tolerability, the daily dose can be increased to 1500mg each time, twice a day. The dose should be increased or decreased by 500mg/time, twice a day, every 2-4 weeks. Elderly (≥65 years): Adjust the dose according to renal function (see below for details on patients with impaired renal function). Children aged 4-11 years and adolescents (12-17 years) weighing ≤50 kg: The initial treatment dose is 10 mg/kg, twice a day. Depending on clinical response and tolerability, the dose can be increased to 30 mg/kg, twice a day. The dose should be increased or decreased by 10 mg/kg, twice a day every two weeks. The lowest effective dose should be used as much as possible. Children and adolescents weighing ≥50 kg: The dose is the same as that for adults. Tablets Table 1 Recommended doses for adolescents and children Note: For children under 25 kg, oral solution should be used to accurately adjust the dose. Infants and children under 4 years of age: There is currently no sufficient data. Patients with impaired renal function: Adjust the daily dose according to renal function. Table 1 Dosage adjustment for adults with impaired renal function (1) The recommended loading dose on the first day of treatment is 750 mg of levetiracetam. (2) After dialysis, an additional dose of 250-500 mg is recommended. The dose of levetiracetam should be adjusted according to the renal function status in children with renal impairment, because the clearance of levetiracetam is related to renal function. The recommended adjustment method is based on studies in adult patients with renal impairment. The creatinine clearance of adolescents and children can be obtained by the following formula: CLcr (ml/min/1.73m2) = height (cm) × ks/serum creatinine value (mg/dl) ks = 0.45 (full-term infants to 1 year old); ks = 0.55 (children under 13 years old and female adolescents); ks = 0.7 (male adolescents) Table 2 Dose adjustment for children and adolescents with renal impairment weighing <50kg (1) The recommended loading dose on the first day of administration is levetiracetam 15mg/kg. (2) After dialysis, an additional dose of 5-10mg/kg is recommended. Patients with liver disease: No dose adjustment is required for patients with mild and moderate liver impairment. In patients with severe liver damage, the degree of renal insufficiency may be underestimated based on creatinine clearance. Therefore, if the patient's creatinine clearance is less than 60ml/min, the daily dose should be halved. Extended-release tablets are taken orally once a day. The tablets should be swallowed whole and should not be chewed, broken or crushed. The initial treatment dose is 1000mg, once a day. The daily dose is increased by 1000mg every two weeks until the maximum recommended dose of 3000mg/day is reached. Dose adjustment for adult patients with renal insufficiency: The dose must be adjusted according to the patient's renal function status. The recommended dose adjustment is shown in the following table. The oral solution can be diluted with water for oral administration. The commercially available packaged oral solution is equipped with a graduated oral dispenser and instructions for use. The daily dose is taken in 2 equal doses. Table 1 Recommended dose for infants, children and adolescents over 6 months old Table 2 Recommended dose for infants, children and adolescents over 1-6 months old The concentrated solution for injection can be used for initial treatment. There is no need to gradually increase or decrease the dose when switching between oral and intravenous administration, but the daily dose and the number of doses should remain unchanged. For intravenous administration, the recommended dose of concentrate needs to be diluted in 100 ml of diluent and then injected intravenously over 15 minutes. The recommended dose for children and adolescents, the dose adjusted for renal function, and the dose for patients with liver disease are the same as tablets. Adverse reactions: The safety data summarized in adult clinical studies showed that the incidence of adverse reactions in the drug group and the placebo group was similar, 46.4% and 42.2%, respectively. Among them, serious adverse reactions were 2.4% and 2.0%, respectively. The most common adverse reactions were drowsiness, fatigue, and dizziness, which often occurred at the beginning of treatment. Over time, the incidence and severity of adverse reactions related to the central nervous system will decrease. There is no obvious dose-related adverse reaction of levetiracetam. Clinical studies in children (4-16 years old) showed that the incidence of adverse reactions in the drug group and the placebo group was similar, 55.4% and 40.2%, respectively, and no serious adverse reactions occurred in the drug group (1.0% in the placebo group). The most common adverse reactions in children are drowsiness, hostility, nervousness, emotional instability, irritability, loss of appetite, fatigue, and headache. Except for the higher incidence of behavioral and psychiatric adverse reactions than adults (38.6% in children and 18.6% in adults), the overall safety is similar to that of adults. The risks of adverse reactions in adults and children are comparable. Summarizing the clinical study results and post-marketing experience in adults and children, the adverse reactions and frequency of each system were evaluated: very common>10%; common 1-10%; uncommon 0.1-1%; rare: 0.01-0.1%; very rare<0.01%, including separate reports. The data from post-marketing clinical applications are not sufficient to estimate the incidence of adverse reactions in the treatment population. Systemic reactions and discomfort at the site of administration: fatigue is very common. Nervous system discomfort: drowsiness is very common, and amnesia, ataxia, convulsions, dizziness, headache, hypermobility, and tremor are common. Mental and psychological changes: irritability, depression, emotional instability, hostility, insomnia, nervousness, personality changes, and abnormal thinking are common. Drug contraindications: Allergic to this product is prohibited. Use with caution in patients with liver function impairment. Use with caution in patients with kidney function impairment.