Roweepra XR Dosage

Generic name: LEVETIRACETAM 500mg
Dosage form: tablet, extended release

2.1 Recommended Dosing

ROWEEPRA XR is administered once daily.

Initiate treatment with a dose of 1,000 mg once daily. The once daily dosage may be adjusted in increments of 1,000 mg every 2 weeks to a maximum recommended daily dose of 3,000 mg/day.

2.2 Dosage Adjustment in Adult Patients with Renal Impairment

ROWEEPRA 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, 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:

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

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

CLcr (mL/min)
CLcr(mL/min/1.73m 2 )=--------------- x 1.73
BSA subject (m 2 )

Table 1: Dosage Adjustment Regimen for Adult Patients with Renal Impairment
Group	Creatinine Clearance (mL/min/1.73m 2 )	Dosage (mg)	Frequency
Normal	> 80	1,000 to 3,000	Every 24 hours
Mild	50 - 80	1,000 to 2,000	Every 24 hours
Moderate	30 - 50	500 to 1,500	Every 24 hours
Severe	<30	500 to 1,000	Every 24 hours