RILUTEK TABLET 50 mg

INDICATIONS AND USAGE

RILUTEK is indicated for the treatment of patients with Amyotropic Lateral Sclerosis (ALS).

Riluzole extends survival and/or time to tracheostomy.

CONTRAINDICATIONS

RILUTEK is contraindicated in patients who have history of severe hypersensitivity reactions to riluzole or any of the tablet components.

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

Special Populations

Patients with Impaired or Renal or Hepatic Function: Studies have not yet been completed in these populations (see WARNINGS, PRECAUTIONS, CLINICAL PHARMACOLOGY – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).