Drug Catalog - Product Detail
RILUZOLE TAB 50 MG 60 CT
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 62756-0538-86 | SUN PHARMACEUTICALS | 60 | 50MG | TABLET |
PACKAGE FILES
Generic Name
RILUZOLE
Substance Name
RILUZOLE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA091417
Description
11 DESCRIPTION Riluzole is a member of the benzothiazole class. The chemical designation for riluzole is 2-amino-6-(trifluoromethoxy) benzothiazole. Its molecular formula is C 8 H 5 F 3 N 2 OS, and its molecular weight is 234.2. The chemical structure 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 N HCl; and very slightly soluble in water and in 0.1 N NaOH. Each film-coated tablet for oral use contains 50 mg of riluzole, USP and the following inactive ingredients: anhydrous dibasic calcium phosphate, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, povidone, talc and titanium dioxide. structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Riluzole tablets, USP 50 mg are white to off white colored, round-shaped, biconvex film-coated tablets and debossed with “538” on one side and plain on other side. They are supplied as follows: Bottles of 30's with child-resistant closure.......................NDC 62756-538-83 Bottles of 60's with child-resistant closure.......................NDC 62756-538-86 Bottles of 100's withchild-resistant closure.....................NDC 62756-538-88 Bottles of 1000's ..................................................................NDC 62756-538-18 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature] and protect from bright light. Keep out of the reach of children.
Indications & Usage
1 INDICATIONS AND USAGE Riluzole tablets, USP are indicated for the treatment of amyotrophic lateral sclerosis (ALS). Riluzole is indicated for the treatment of amyotrophic lateral sclerosis (ALS) (1)
Dosage and Administration
2 DOSAGE AND ADMINISTRATION The recommended dosage for riluzole is 50 mg taken orally twice daily. Riluzole should be taken at least 1 hour before or 2 hours after a meal [ see Clinical Pharmacology (12.3)] . Measure serum aminotransferases before and during treatment with riluzole [ see Warnings and Precautions (5.1) ]. Recommended dosage: 50 mg twice daily, taken at least 1 hour before or 2 hours after a meal (2) Measure serum aminotransferases before and during treatment ( 2 , 5.1 )