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Rilutek Indications, Dosage, Storage, Stability - Riluzole
INDICATIONS
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 as least an hour before, or two hours after, a meal to avoid a food-related decrease in bioavailability.
Special Populations
Patients with Impaired Renal or Hepatic Function: Studies have not yet been completed in these populations (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. These bottles are designed with a special dispensing flip cap to aid dispensing with minimum effort.
STORE AT CONTROLLED ROOM TEMPERATURE 20°-25°C (68°-77°F) AND PROTECT FROM BRIGHT LIGHT.
KEEP OUT OF THE REACH OF CHILDREN.
Caution: Federal law prohibits dispensing without prescription.
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