生产厂家：Daito Co., Ltd.
RILUTEK (riluzole) is a member of the benzothiazole class. Chemically, riluzole is 2-amino-6-(trifluoromethoxy) benzothiazole. Its molecular formula is C8H5F3N2OS and its molecular weight is 234.2. Its structual formula is:
Riluzole is a white to slightly yellow powder that is very soluble in dimethylformamide, dimethylsulfoxide and methanol, freely soluble in dichloromethane, sparingly soluble in 0.1 NHCl and very slightly soluble in water and in 0.1 N NaOH. RILUTEK is available as a capsule-shaped, white, film-coated tablet for oral administration containing 50 mg of riluzole. Each tablet is engraved with RPR 202 on one side.
Inactive Ingredients: Core: anhydrous dibasic calcium phosphate, USP; microcrystalline cellulose, NF; anhydrous colloidal silica, NF; magnesium stearate, NF; croscarmellose sodium, NF. Film coating: hydroxypropyl methylcellulose, USP; polyethylene glycol 6000; titanium dioxide, USP.
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 50mg 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.
Patients with Impaired Renal or Hepatic Function: Studies have not yet been completed in these populations (see WARNINGS, PRECAUTIONS, CLINICAL PHARMACOLOGY).
RILUTEK 50mg 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.