Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
TABLET, FILM COATED
**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_).
ORAL
Medical Information
**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.
N07XX02
riluzole
Manufacturer Information
SANOFI-AVENTIS SINGAPORE PTE. LTD.
Opella Healthcare International SAS
Active Ingredients
Documents
Package Inserts
Rilutek PI.pdf
Approved: June 28, 2010