Vigabatrin

Usual Dosing (Adults)

INDICATIONS AND USAGE: Refractory Complex Partial Seizures in Adults - SABRIL® is indicated as adjunctive therapy for adult patients with refractory complex partial seizures (CPS) who have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss [see package insert for WARNINGS AND PRECAUTIONS]. SABRIL is not indicated as a first line agent for complex partial seizures.

DOSAGE AND ADMINISTRATION: Refractory Complex Partial Seizures in Adults - SABRIL 500 mg tablets should be given as twice daily oral administration with or without food. Therapy should be initiated at 1 g/day (500 mg twice daily). Total daily dose may be increased in 500 mg increments at weekly intervals depending on response. The recommended dose of SABRIL in adults is 3 g/day (1.5 g twice daily). A 6 g/day dose has not been shown to confer additional benefit compared to the 3 g/day dose and is associated with an increased incidence of adverse events.

General Dosing Considerations: SABRIL should be withdrawn gradually. In controlled clinical studies in adults with CPS, vigabatrin was tapered by decreasing the daily dose 1 g/day on a weekly basis until discontinued [see package insert for WARNINGS AND PRECAUTIONS, Withdrawal of Antiepileptic Drugs (AEDs)].

Renal Dosing

Patients with Renal Impairment
SABRIL is primarily eliminated through the kidney. In patients with renal impairment, dose adjustments should be made as follows:

In patients with mild renal impairment (CLcr >50 to 80 mL/min), the dose should be decreased by 25%.

In patients with moderate renal impairment (CLcr >30 to 50 mL/min), the dose should be decreased by 50%.

In patients with severe renal impairment (CLcr >10 to <30 mL/min), the dose should be decreased by 75%.

Creatinine clearance for males =	[140-age (years)]× [body wt (kg)] 72 × [serum creatinine (mg/dL)]
Creatinine clearance for females =	[140-age (years)]× [body wt (kg)]× 0.85 72 × [serum creatinine (mg/dL)]

The effect of dialysis on SABRIL clearance has not been adequately studied.

Hemodialysis

See comments above

Reference(s)

National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
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