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Keppra XR (Levetiracetam) - Indications and Dosage

 
 



INDICATIONS AND USAGE

KEPPRA XR™ is indicated as adjunctive therapy in the treatment of partial onset seizures in patients ≥16 years of age with epilepsy.

DOSAGE AND ADMINISTRATION

Treatment should be initiated with a dose of 1000 mg once daily. The daily dosage may be adjusted in increments of 1000 mg every 2 weeks to a maximum recommended daily dose of 3000 mg.

Adult Patients With Impaired Renal Function

KEPPRA XR dosing must be individualized according to the patient's renal function status. Recommended doses and adjustment for dose for adults are shown in Table 1. To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in mL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL) determination using the following formula:

                 [140-age (years)] x weight (kg)
CLcr =   ----------------------------------------------    x 1 0.85
                 72 x serum creatinine (mg/dL)
1. For female patients

Then CLcr is adjusted for body surface area (BSA) as follows:

                                                 CLcr (mL/min)
CLcr (mL/min/1.73m2) =    -----------------------------    x 1.73
                                               BSA subject (m2)

Table 1: Dosing Adjustment Regimen For Adult Patients With Impaired Renal Function
GroupCreatinine
Clearance
(mL/min/1.73m2)
Dosage
(mg)
Frequency
Normal> 801000 to 3000 Every 24 h
Mild50 – 801000 to 2000 Every 24 h
Moderate30 – 50500 to 1500Every 24 h
Severe< 30500 to 1000Every 24 h

DOSAGE FORMS AND STRENGTHS

KEPPRA XR tablets are white, oblong-shaped, film-coated extended-release tablets imprinted in red with "UCB 500XR" on one side and contain 500 mg levetiracetam.

KEPPRA XR tablets are white, oblong-shaped, film-coated extended-release tablets imprinted in red with "UCB 750XR" on one side and contain 750 mg levetiracetam.

HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

KEPPRA XR 500 mg tablets are white, oblong-shaped, film-coated tablets imprinted with "UCB 500XR" in red on one side. They are supplied in white HDPE bottles containing 60 tablets (NDC 50474-598-66).

KEPPRA XR 750 mg tablets are white, oblong-shaped, film-coated tablets imprinted with "UCB 750XR" in red on one side. They are supplied in white HDPE bottles containing 60 tablets (NDC 50474-599-66).

Storage

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

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