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Conversion to or from oral to intravenous administration can be done directly without titration. The total daily dose and frequency of administration should be maintained.
Partial onset seizures: The recommended dosing for monotherapy (from 16 years of age) and adjunctive therapy is the same; as outlined as follows.
All indications: Adults (≥18 years of age) and adolescents (12-17 years of age) weighing 50 kg or more: The initial therapeutic dose is 500 mg twice daily. This dose can be started on the first day of treatment. However, a lower initial dose of 250 mg twice daily may be given based on physician assessment of seizure reduction versus potential side effects. This can be increased to 500 mg twice daily after two weeks.
Depending upon the clinical response and tolerability, the daily dose can be increased up to 1,500 mg twice daily. Dose changes can be made in 250 mg or 500 mg twice daily increases or decreases every two to four weeks.
Adolescents (12 to 17 years) weighing below 50 kg and children from 4 years of age: The physician should prescribe the most appropriate pharmaceutical form, presentation and strength according to weight, age and dose. Refer to Pediatric population section for dosing adjustments based on weight.
Duration of treatment: There is no experience with administration of intravenous Levetiracetam for longer period than 4 days.
Discontinuation: If Levetiracetam has to be discontinued it is recommended to withdraw it gradually (e.g., in adults and adolescents weighing more than 50 kg: 500 mg decreases twice daily every two to four weeks; in children and adolescents weighing less than 50 kg: dose decrease should not exceed 10 mg/kg twice daily every two weeks).
Special populations: Elderly (65 years and older): Adjustment of the dose is recommended in elderly patients with compromised renal function (see Renal impairment as follows).
Renal impairment: The daily dose must be individualized according to renal function.
For adult patients, refer to the following table and adjust the dose as indicated. To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in mL/min is needed. The CLcr in mL/min may be estimated from serum creatinine (mg/dl) determination, for adults and adolescents weighing 50 kg or more, the following formula: see Equation 1.
Click on icon to see table/diagram/imageThen CLcr is adjusted for body surface area (BSA) as follows: see Equation 2.
Click on icon to see table/diagram/imageDosing adjustment for adult and adolescent patients weighing more than 50 kg with impaired renal function: see Table 1.
Click on icon to see table/diagram/imageFor children with renal impairment, Levetiracetam dose needs to be adjusted based on the renal function as Levetiracetam clearance is related to renal function. This recommendation is based on a study in adult renally impaired patients.
The CLcr in mL/min/1.73 m2 may be estimated from serum creatinine (mg/dl) determination for young adolescents and children using the following formula (Schwartz formula): see Equation 3.
Click on icon to see table/diagram/imageks = 0.55 in Children to less than 13 years and in adolescent female; ks = 0.7 in adolescent male.
Dosing adjustment for children and adolescent patients weighing less than 50 kg with impaired renal function: see Table 2.
Click on icon to see table/diagram/imageHepatic impairment: No dose adjustment is needed in patients with mild to moderate hepatic impairment.
In patients with severe hepatic impairment, the creatinine clearance may underestimate the renal insufficiency.
Therefore a 50% reduction of the daily maintenance dose is recommended when the creatinine clearance is <60 mL/min/1.73 m2.
Pediatric population: The physician should prescribe the most appropriate pharmaceutical form, presentation and strength according to age, weight and dose.
Monotherapy: The safety and efficacy of Levetiracetam in children and adolescents below 16 years as monotherapy treatment have not been established.
No data are available.
Adolescents (16 and 17 years of age) weighing 50 kg or more with partial onset seizures with or without secondary generalization with newly diagnosed epilepsy: Refer to the previous section on Adults (≥18 years) and adolescents (12 to 17 years) weighing 50 kg or more.
Add-on therapy for children aged 4 to 11 years and adolescents (12 to 17 years) weighing less than 50 kg: The initial therapeutic dose is 10 mg/kg twice daily.
Depending upon the clinical response and tolerability, the dose can be increased up to 30 mg/kg twice daily. Dose changes should not exceed increases or decreases of 10 mg/kg twice daily every two weeks. The lowest effective dose should be used for all indications.
Dose in children 50 kg or greater is the same as in adults for all indications.
Refer to the previous section on Adults (≥18 years) and adolescents (12 to 17 years) weighing 50 kg or more for all indications.
Dose recommendations for children and adolescents: see Table 3.
Click on icon to see table/diagram/imageAdd-on therapy for infants and children less than 4 years: The safety and efficacy of Levetiracetam concentrate for solution for infusion in infants and children less than 4 years have not been established.
Currently available data are described in Adverse Reactions, and Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions but no recommendation on a posology can be made.
Method of administration: Levetiracetam concentrate is for intravenous use only and the recommended dose must be diluted in at least 100 mL of a compatible diluent and administered intravenously as a 15-minute intravenous infusion (see Special precautions for disposal and other handling under Cautions for Usage).
