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Focale

Focale Dosage/Direction for Use

levetiracetam

Manufacturer:

Atlantic Pharma

Distributor:

UNILAB, Inc
Full Prescribing Info
Dosage/Direction for Use
(See Tables 1 and 2.)

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SPECIAL POPULATION: Patients with Renal Impairment: The daily dose of levetiracetam must be individualized according to patient's renal function. (See Table 3.)

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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 using the following formula: See Equation 1.

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

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Children with Renal Impairment: The daily dose of levetiracetam must be individualized according 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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ks= 0.55 in Children to less than 13 years and in adolescent female; ks= 0.7 in adolescent male.
Dosing adjustment for children and adolescents patients weighing less than 50 kg with impaired renal function: See Table 4.

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Patients with Hepatic Impairment: Severe Hepatic Impairment: A 50% reduction of the daily maintenance dose is recommended when the creatinine clearance is <70 mL/min. No dose adjustment is needed for patients with mild to moderate hepatic impairment.
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