Rx Item-Riluzole 50Mg Tab 60 By Ascend Pharma Gen Rilutek

Clinical Information
Gen. Code and Des.
24508 riluzole ORAL TABLET 50 MG
GCN and Des.
12120 riluzole ORAL TABLET 50 MG
Strength
50MG
Dose Form
TABLET
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
28920000 CENTRAL NERVOUS SYSTEM AGENTS, MISC.
Active Ingredients
5183 riluzole 1744225




RILUTEK- riluzole tablet
Covis Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE

RILUTEK is indicated for the treatment of amyotrophic lateral sclerosis (ALS).

2 DOSAGE AND ADMINISTRATION

The recommended dosage for RILUTEK is 50 mg taken orally twice daily. RILUTEK 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 RILUTEK [see Warnings and Precautions (5.1)].

3 DOSAGE FORMS AND STRENGTHS

Tablets: 50 mg film-coated, capsule-shaped, white, with "RPR 202" on one side.

4 CONTRAINDICATIONS

RILUTEK is contraindicated in patients with a history of severe hypersensitivity reactions to riluzole or to any of its components (anaphylaxis has occurred) [see Adverse Reactions (6.1)].
DESCRIPTION

RILUTEK (riluzole) is a member of the benzothiazole class. The chemical designation for riluzole is 2-amino-6-(trifluoromethoxy)benzothiazole. Its molecular formula is C8 H5 F3 N2 OS, and its molecular weight is 234.2
RILUTEK 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 and the following inactive ingredients: anhydrous dibasic calcium phosphate, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide.

PATIENT COUNSELING INFORMATION

Advise patients to inform their healthcare provider if they experience:

�
Yellowing of the whites of the eyes [see Warnings and Precautions (5.1)]
�
Fever [see Warnings and Precautions (5.2)]
�
Respiratory symptoms-for example, dry cough and difficult or labored breathing [see Warnings and Precautions (5.3)]

RX ITEM-Riluzole 50Mg Tab 60 By Ascend P
NDC 64980-0191-06 UPC/GTIN No.3-64980-19106-7 Mfg.Part No.19106

Riluzole 50Mg Tab 60 By Ascend Pharma
BRAND: RILUZOLE NDC: 64980-0191-06,64980019106 UPC: 3-64980-19106-7,364980191067

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