Rilutek (Riluzole) - Indications and Dosage

INDICATIONS AND USAGE

RILUTEK is indicated for the treatment of patients with amyotrophic lateral sclerosis (ALS). Riluzole extends survival and/or time to tracheostomy.

DOSAGE AND ADMINISTRATION

The recommended dose for RILUTEK is 50 mg every 12 hours. No increased benefit can be expected from higher daily doses, but adverse events are increased.

RILUTEK tablets should be taken at least an hour before, or two hours after, a meal to avoid a food-related decrease in bioavailability.

Special Populations

Patients with Impaired Hepatic Function

see WARNINGS, PRECAUTIONS, CLINICAL PHARMACOLOGY.

HOW SUPPLIED

RILUTEK 50 mg tablets are white, film-coated, capsule-shaped and engraved with "RPR 202" on one side. RILUTEK is supplied in bottles of 60 tablets, NDC 0075-7700-60.

STORE AT CONTROLLED ROOM TEMPERATURE 20°–25°C (68°–77°F) AND PROTECT FROM BRIGHT LIGHT.

KEEP OUT OF THE REACH OF CHILDREN.