Focale Dosage/Direction for Use

Mode of Administration: Film-coated tablet: For oral use (immediate release tablet): The film-coated tablets must be taken orally, swallowed with a sufficient quantity of liquid and may be taken with food or without food. The daily dose is administered in two equally divided dose.
Injection: For IV use only as a 15-minute IV infusion.
Admixture compatibility: Levetiracetam is physically compatible and chemically stable when mixed with the following diluent: Sodium Chloride 0.9% injection, Dextrose 5% injection, and Ringer's lactate injection. Levetiracetam is compatible with the following AEDs: lorazepam, diazepam, and valproate sodium.
Levetiracetam injection was diluted to a target concentration of approximately 5 mg/mL by injection approximately 5.0 mL of the injection into the infusion bags of 0.9% Sodium Chloride Injection, Lactated Ringer's Injection and 5% Dextrose Injection individually. The procedure resulted in 100 mL of diluted injection.
A smaller volume of diluent may be used (e.g., in pediatric patients or patients who may be susceptible to fluid volume overload), but the final concentration of the diluted solution should not exceed 15 mg/mL. The product should be used immediately after dilution. If not used immediately, in-use storage time and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 30°C, unless dilution has taken place in controlled and validated aseptic conditions.
Levetiracetam injection and diluted solution of the drug should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Levetiracetam injection is for intravenous use only.
Recommended Dose: Adults: Monotherapy: 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 2 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: 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 tolerance, the daily dose can be increased up to 1,500 mg twice daily. Dose changes can be made in 500 mg twice daily increased or decreases every two to four weeks.
Children: 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.
Add-on therapy for children (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 increments or decrements 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. (See Table 1.)

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Switching From or To Oral Levetiracetam: When switching from oral to IV levetiracetam therapy, the initial total daily dosage of IV levetiracetam should be equivalent to the daily dose and frequency of oral levetiracetam.
At the completion of the IV treatment period, the patient may be switched back to oral levetiracetam at the equivalent daily dose and frequency that was administered IV.
Dosage adjustments in Special populations: Geriatic use: Film-coated tablet: Controlled Clinical Studies evaluating levetiracetam have not included sufficient number patients 65 years of age and older to determine whether geriatric patients respond differently than younger adults. No substantial differences in safety have been observed in geriatric patients relative to younger adults.
Renal function 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, using 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 adolescent patients weighing more than 50 kg with impaired renal function. (See Table 2.)

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The 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 using, for young adolescents and children using the following formula (Schwartz formula): See Equation 3.

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Dosing adjustment for children and adolescent patients weighing less than 50 kg with impaired renal function. (See Table 3.)

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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/1.73m²