"The U.S. Food and Drug Administration today approved Aptiom (eslicarbazepine acetate) as an add-on medication to treat seizures associated with epilepsy.
Epilepsy is a brain disorder caused by abnormal or excessive activity in the brain"...
KEPPRA XR® is indicated as adjunctive therapy in the treatment of partial onset seizures in patients ≥ 12 years of age with epilepsy.
DOSAGE AND ADMINISTRATION
General Dosing Recommendations
KEPPRA XR is administered once daily.
Treatment should be initiated with a dose of 1000 mg once daily. The once daily dosage may be adjusted in increments of 1000 mg every 2 weeks to a maximum recommended once 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. In order to calculate the dose recommended for patients with renal impairment, creatinine clearance adjusted for body surface area must be calculated. To do this, an estimate of the patient's creatinine clearance (CLcr) in mL/min must first be calculated using the following formula:
|Males:||(weight in kg) x (140 – age)|
|(72) x serum creatinine (mg/100 mL)|
|Females||(0.85) x (above value)|
Then CLcr is adjusted for body surface area (BSA) as follows:
CLcr (mL/min/1.73m²)= CLcr (mL/min)/ BSA subject (m²) x 1.73
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 hours|
|Mild||50 - 80||1000 to 2000||Every 24 hours|
|Moderate||30 - 50||500 to 1500||Every 24 hours|
|Severe||< 30||500 to 1000||Every 24 hours|
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.
Storage And Handling
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).
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].
Distributed by UCB, Inc. Smyrna, GA 30080. Rev. Aug 2014
Last reviewed on RxList: 8/15/2014
This monograph has been modified to include the generic and brand name in many instances.
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