Epitech Dosage/Direction for Use

Posology: Levetiracetam therapy can be initiated with either intravenous or oral administration. 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.
Monotherapy for adults and adolescents from 16 years of age: The recommended starting dose is 250 mg twice daily which should be increased to an initial therapeutic dose of 500 mg twice daily after two weeks. The dose can be further increased by 250 mg twice daily every two weeks depending upon the clinical response. The maximum dose is 1500 mg twice daily.
Add-on therapy for adults (≥18 years) and adolescents (12 to 17 years) 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.
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 500 mg twice daily increases or decreases every two to four weeks.
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 weighting 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 individualised according to renal function.
For adult patients, refer to the table as follows 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 weighting 50 kg or more, the following formula: (see Equation 1).

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Then CLcr is adjusted for body surface area (BSA) as follows: (see Equation 2).

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Dosing adjustment for adult and adolescents patients weighing more than 50 kg with impaired renal function: (see Table 1).

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For 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).

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Dosing adjustment for children and adolescents patients weighing less than 50 kg with impaired renal function: (see Table 2).

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Hepatic 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.
Paediatric 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 below and adolescents 16 years as monotherapy treatment have not been established.
No data are available.
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.
Dose in children 50 kg or greater is the same as in adults: Dose recommendations for children and adolescents: (see Table 3.)

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Add-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.
Route 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.