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
General Dosing Considerations: SABRIL should be withdrawn gradually.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
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%.
The effect of dialysis on SABRIL clearance has not been adequately
See comments above
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The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical
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