Refractory Complex Partial Seizures in Adults

SABRIL® (vigabatrin oral solution) 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 WARNINGS AND PRECAUTIONS, Vision Loss]. SABRIL (vigabatrin oral solution) is not indicated as a first line agent for complex partial seizures.

Refractory Complex Partial Seizures in Adults

SABRIL (vigabatrin oral solution) 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 (vigabatrin oral solution) 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.

Patients with Renal Impairment

SABRIL (vigabatrin oral solution) 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%; and in patients with severe renal impairment (CLcr > 10 to < 30 mL/min), the dose should be decreased by 75%.

CLcr in mL/min may be estimated from a serum creatinine (mg/dL) determination using the following formula:

CLcr*= [140-agre (years)] x weight (kg)/72 x serum creatinine (mg/dL)]

* [x Q.85 for female patients]

The effect of dialysis on SABRIL (vigabatrin oral solution) clearance has not been adequately studied.

[see CLINICAL PHARMACOLOGY, Pharmacokinetics, Renal Impairment and Use In Specific Populations, Renal Impairment].

General Dosing Considerations

SABRIL (vigabatrin oral solution) should be withdrawn gradually.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 WARNINGS AND PRECAUTIONS, Withdrawal of Antiepileptic Drugs (AEDs)].

Dosage Forms and Strengths

Tablet

500 mg Tablet.

SABRIL Tablet

Each SABRIL film-coated tablet contains 500 mg vigabatrin and is white, film-coated, oval, biconvex, scored on one side, and debossed with OV 111 on the other.

NDC 67386-111-01: Bottles of 100.

Store at 20-25°C (68-77°F). See USP controlled room temperature.

Manufactured by: Patheon Cincinnati, OH 45237, U.S.A. For: Lundbeck Inc. Deerfield, IL 60015, U.S.A.

Last reviewed on RxList: 3/7/2011
This monograph has been modified to include the generic and brand name in many instances.