Información de la droga para KEPPRA XR (UCB, Inc.): 2 DOSAGE AND ADMINISTRATION

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  • 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.

  • 2.1 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
    GroupCreatinineClearance(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
  • Drug Information Provided by National Library of Medicine (NLM).
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