Keppra Xr

Keppra Xr Manufacturers

• Rxpak Division Of Mckesson Corporation
  

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  Keppra Xr | Rxpak Division Of Mckesson Corporation

  

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  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.

  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. 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:

  CLcr=

  [140-age (years)] × weight (kg)

  (× 0.85 for female patients)

  72 × serum creatinine (mg/dL)

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

  CLcr (mL/min/1.73m2)=

  CLcr (mL/min)

  × 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 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

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• Ucb, Inc.
  

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  Keppra Xr | Ucb, Inc.

  

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  2.1 Recommended Dosing

  KEPPRA XR is administered once daily.

  Initiate treatment 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 daily dose of 3000 mg/day.

  2.2 Dosage Adjustment in Adult Patients with Renal Impairment

  KEPPRA XR dosing must be individualized according to the patient's renal function status. Recommended dosage adjustments for adults are shown in Table 1. In order to calculate the dose recommended for patients with renal impairment, creatine 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:

  CLcr= [140-age (years)] × weight (kg) (× 0.85 for female patients) 72 × serum creatinine (mg/dL)

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

  CLcr (mL/min/1.73m2)= CLcr (mL/min) × 1.73 BSA subject (m2) Table 1: Dosage Adjustment Regimen for Adult Patients with Renal Impairment 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

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