Elepsia XR Dosage

Recommended Dosing

ELEPSIA XR is administered orally 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.

ELEPSIA XR should be taken whole; do not split or cut tablets.

Dosage Adjustment in Adult Patients with Renal Impairment

ELEPSIA XR is not recommended for use in patients with moderate or severe renal impairment. Recommended doses and adjustment for patients with mild renal impairment 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:

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

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

Discontinuation of ELEPSIA XR

When discontinuing ELEPSIA XR, reduce the dosage gradually and avoid abrupt discontinuation because of the risk of increased seizure frequency and status epilepticus [see Warnings and Precautions (5.7)].