Levetiracetam
Visa No.: 893110453524
Product: Tirastam 500mg
API: Levetiracetam
Product Category: Others
Version approved leaflet: 26287e/QLD - ĐK_31/07/2025
INDICATIONS
Levetiracetam is indicated as monotherapy for the treatment of partial-onset seizures, with or without secondary generalization, in adults and adolescents 16 years of age and older with newly diagnosed epilepsy.
It is also indicated as adjunctive treatment:
- For the treatment of partial-onset seizures, with or without secondary generalization, in adults and children from 1 month of age.
- For the treatment of myoclonic seizures in adults and adolescents ≥12 years with juvenile myoclonic epilepsy.
- For the treatment of primary generalized tonic–clonic seizures in adults and adolescents ≥12 years with idiopathic generalized epilepsy.
DOSAGE AND ADMINISTRATION
Levetiracetam film-coated tablets should be swallowed with a sufficient amount of liquid and may be taken with or without food. The total daily dose should be pided into two equal doses.
Monotherapy in adults and adolescents ≥16 years:
The initial dose is 250 mg twice daily, increased to the therapeutic dose of 500 mg twice daily after 2 weeks. The dose may be further increased by 250 mg twice daily every 2 weeks depending on clinical response. The maximum dose is 1500 mg twice daily.
Adjunctive treatment
Adults (≥18 years) and adolescents (12–17 years) weighing ≥50 kg: The initial therapeutic dose is 500 mg twice daily. This dose may be started from the first day of treatment.
Depending on clinical response and tolerability, the dose may be increased up to 1500 mg twice daily. Dose adjustments, either increases or decreases of 500 mg twice daily, may be made at intervals of 2 to 4 weeks
Discontinuation of treatment
When discontinuing Levetiracetam, the dose should be tapered gradually before stopping completely. In adults and adolescents weighing 50 kg or more, the dose should be reduced by 500 mg twice daily every 2 to 4 weeks. In infants older than 6 months, children, and adolescents weighing less than 50 kg, the dose reduction should not exceed 10 mg/kg twice daily every 2 weeks. In infants younger than 6 months, the dose reduction should not exceed 7 mg/kg twice daily every 2 weeks.
Elderly (≥65 years)
Dose adjustment is recommended in elderly patients with impaired renal function (see Patients with renal impairment below).
Patients with Renal Impairment
For adults, refer to the dosing table below and adjust the dose as recommended. To use this table, creatinine clearance (Clcr) in mL/min should be estimated. In adults and adolescents weighing >50 kg, Clcr (mL/min) may be estimated from serum creatinine (mg/dL) using the following formula:
Clcr should then be adjusted for body surface area (BSA) as follows: :
Dose adjustment in adults and adolescents weighing >50 kg with renal impairment:
| Group | Creatine clearance (ml/min/1,73 m²) | Dose and frequency |
| Normal | > 80 | 500 – 1500 mg twice daily |
| Mild impairment | 50 - 79 | 500 – 1000 mg twice daily |
| Moderate impairment | 30 - 49 | 250 – 750 mg twice daily |
| Severe impairment | <30 | 250 – 500 mg twice daily |
| End-stage renal disease (on dialysis) (1) | - | 500 – 1000 mg once daily (2) |
(1) A loading dose of 750 mg is recommended on the first day of treatment with Levetiracetam.
(2) A supplemental dose of 250–500 mg is recommended after each dialysis session.Bệnh nhân suy gan
No dose adjustment is required in patients with mild to moderate hepatic impairment. In patients with severe hepatic impairment, creatinine clearance may underestimate the degree of renal impairment. Therefore, a 50% reduction of the daily maintenance dose is recommended when creatinine clearance is <60 mL/min/1.73 m².
Pediatric population: Physicians should prescribe the most appropriate dosage form, strength, and presentation according to the child’s age, body weight, and required dose.
Tablet formulations are not suitable for use in infants and children under 6 years of age. Levetiracetam oral solution is appropriate for this population.
In addition, the available tablet strengths are not suitable for initial treatment in children weighing less than 25 kg, for patients unable to swallow tablets, or for doses below 250 mg. In all such cases, levetiracetam oral solution should be used.
CONTRAINDICATIONS
Hypersensitivity to Levetiracetam or to any component of the medicine.
WARNINGS AND PRECAUTIONS
Prescription only medicine. Read the instructions before use. Consult a physician or pharmacist if needed. Keep out of reach of children.
