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Keppra XR

"Introduction

Few experiences match the drama of a convulsive seizure. A person having a severe seizure may cry out, fall to the floor unconscious, twitch or move uncontrollably, drool, or even lose bladder control. Within minutes, the"...

Keppra XR

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INDICATIONS

KEPPRA XR (levetiracetam extended-release tablets) ™ 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 (levetiracetam extended-release tablets) 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:

CLcr = [140-age (years)] x weight (kg) x 10.85
72 x serum creatinine (mg/dL)
1. For female patients

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

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

Table 1: Dosing Adjustment Regimen For Adult Patients With Impaired Renal Function

Group Creatinine
Clearance
(mL/min/1.73m²)
Dosage(mg) Frequency
Normal > 80 1000 to 3000 Every 24 h
Mild 50 – 80 1000 to 2000 Every 24 h
Moderate 30 – 50 500 to 1500 Every 24 h
Severe < 30 500 to 1000 Every 24 h

HOW SUPPLIED

Dosage Forms And Strengths

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

KEPPRA XR (levetiracetam extended-release tablets) 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 (levetiracetam extended-release tablets) 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].

KEPPRA XR (levetiracetam extended-release tablets) manufactured for UCB, Inc. Smyrna, GA 30080.

Last reviewed on RxList: 3/13/2009
This monograph has been modified to include the generic and brand name in many instances.

Keppra XR - User Reviews

Keppra XR User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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