Zolevi Dosage/Direction for Use

Dosage: 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 1,500 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.
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 infants older than 6 months, children and adolescents weighing less than 50 kg: dose decrease should not exceed 10 mg/kg twice daily every two weeks; in infants (less than 6 months): dose decrease should not exceed 7 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 following table and adjust the dose as indicated. To use this dosing table, an estimate of the patient's creatinine clearance (Cl_cr) in mL/min is needed. The Cl_cr, in mL/min may be estimated from serum creatinine (mg/dL) determination, for adults and adolescents weighing 50 kg or more, using the following formula: See Equation 1.

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Then Cl_cr 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 Cl_cr in mL/min/1.73m² may be estimated from serum creatinine (mg/dL) determination, for young adolescents, children and infants, using the following formula (Schwartz formula): See Equation 3.

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Dosing adjustment for infants, 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.
The tablet formulation is not adapted for use in infants and children under the age of 6 years. Levetiracetam oral solution is the preferred formulation for use in this population. In addition, the available dose strengths of the tablets are not appropriate for initial treatment in children weighing less than 25 kg, for patients unable to swallow tablets or for the administration of doses below 250 mg. In all of the previously mentioned cases levetiracetam oral solution should be used.
Monotherapy: The safety and efficacy of Levetiracetam in children and adolescents below 16 years as monotherapy treatment have not been established.
There are no data available.
Add-on therapy for infants aged from 6 to 23 months, children (2 to 11 years) and adolescents (12 to 17 years) weighing less than 50 kg: Levetiracetam oral solution is the preferred formulation for use in infants and children under the age of 6 years.
For children 6 years and above, levetiracetam oral solution should be used for doses under 250 mg, for doses not multiple of 250 mg when dosing recommendation is not achievable by taking multiple tablets and for patients unable to swallow tablets.
The lowest effective dose should be used. The starting dose for a child or adolescent of 25 kg should be 250 mg twice daily with a maximum dose of 750 mg twice daily. Dose in children 50 kg or greater is the same as in adults.
Add-on therapy for infants aged from 1 month to less than 6 months: The oral solution is the formulation to use in infants.
Dose recommendations for infants from 6 months of age, children and adolescents: See Table 3.

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Add-on therapy for infants aged from 1 month to less than 6 months: The initial therapeutic dose is 7 mg/kg twice daily.
Depending upon the clinical response and tolerability, the dose can be increased up to 21 mg/kg twice daily. Dose changes should not exceed increases or decreases of 7 mg/kg twice daily every two weeks.
The lowest effective dose should be used.
Infants should start the treatment with levetiracetam 100 mg/mL oral solution.
Dose recommendations for infants aged from 1 month to less than 6 months (see Table 4).

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Three presentations are available: A 300 mL bottle with a 10 mL oral syringe (delivering up to 1000 mg levetiracetam) graduated every 0.25 mL corresponding to 25 mg).
This presentation should be prescribed for children aged 4 years and older, adolescents and adults.
A 150 mL bottle with a 3 mL oral syringe (delivering up to 300 mg levetiracetam) graduated every 0.1 mL (corresponding to 10 mg).
In order to ensure the accuracy of the dosing, this presentation should be prescribed for infants and young children aged from 6 months to less than 4 years.
A 150 mL bottle with a 1 mL oral syringe (delivering up to 100 mg levetiracetam) graduated every 0.05 mL (corresponding to 5 mg).
In order to ensure the accuracy of the dosing, this presentation should be prescribed for infants aged 1 month to less than 6 months.
Method of administration: The film-coated tablets must be taken orally, swallowed with a sufficient quantity of liquid and may be taken with or without food. After oral administration the bitter taste of levetiracetam may be experienced. The daily dose is administered in two equally divided doses.