riluzole 50 mg/1
riluzole · TABLET, FILM COATED · Glenmark Pharmaceuticals Inc., USA
riluzole is a tablet, film coated containing riluzole at 50 mg/1, taken oral. Manufactured by Glenmark Pharmaceuticals Inc., USA.
Key Facts
- Brand Name
- riluzole
- Generic Name
- riluzole
- NDC Code (Product)
68462-381- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Strength
- 50 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA091394
- Drug Class
- Benzothiazole [EPC]
- Marketing Start
- 06/18/2013
Recall History
ITF PHARMA INC
Failed Viscosity Specifications: Out-of-specification test results for viscosity
Aidapak Services, LLC
Labeling: Label Mixup; RILUZOLE Tablet, 50 mg may be potentially mislabeled as traZODone HCl, Tablet, 150 mg, NDC 50111044101, Pedigree: W003245, EXP: 6/17/2014.
Aidapak Services, LLC
Labeling: Label Mixup: RILUZOLE, Tablet, 50 mg may have potentially been mislabeled as the following drug: LACTOBACILLUS, Tablet, 0 mg, NDC 64980012950, Pedigree: AD62986_10, EXP: 5/23/2014.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
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 & 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 )
Contraindications
4 CONTRAINDICATIONS Riluzole tablets are 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) ] . Patients with a history of severe hypersensitivity reactions to riluzole or to any of its components (4)
Drug Interactions
7 DRUG INTERACTIONS Strong to moderate CYP1A2 inhibitors: Coadministration may increase riluzole-associated adverse reactions (7.1) Strong to moderate CYP1A2 inducers: Coadministration may result in decreased efficacy (7.2) Hepatotoxic drugs: Riluzole-treated patients that take other hepatotoxic drugs may be at increased risk for hepatotoxicity (7.3) 7.1 Agents that may Increase Riluzole Blood Concentrations CYP1A2 inhibitors Coadministration of riluzole (a CYP1A substrate) with CYP1A2 inhibitors was not evaluated in a clinical trial; however, in vitro findings suggest an increase in riluzole exposure is likely. The concomitant use of strong or moderate CYP1A2 inhibitors (e.g., ciprofloxacin, enoxacin, fluvoxamine, methoxsalen, mexiletine, oral contraceptives, thiabendazole, vemurafenib, zileuton) with riluzole may increase the risk of riluzole-associated adverse reactions [ see Clinical Pharmacology (12.3) ] . 7.2 Agents that may Decrease Riluzole Plasma Concentrations CYP1A2 inducers Coadministration of riluzole (a CYP1A substrate) with CYP1A2 inducers was not evaluated in a clinical trial; however, in vitro findings suggest a decrease in riluzole exposure is likely. Lower exposu…
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are described below and elsewhere in the labeling: Hepatic Injury [ see Warnings and Precautions (5.1) ] Neutropenia [ see Warnings and Precautions (5.2) ] Interstitial lung disease [ see Warnings and Precautions (5.3) ] Most common adverse reactions (incidence greater than or equal to 5% and greater than placebo) were asthenia, nausea, dizziness, decreased lung function, and abdominal pain ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions in Controlled Clinical Trials In the placebo-controlled clinical trials in patients with ALS (Study 1 and 2), a total of 313 patients received riluzole 50 mg twice daily [ see Clinical Studies (14) ] . The most common adverse reactions in the riluzole group (in at least 5% of patie…
Frequently Asked Questions
What is riluzole used for?
riluzole contains riluzole. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is riluzole a controlled substance?
riluzole is not classified as a controlled substance by the DEA.
What is the generic name for riluzole?
The generic name for riluzole is riluzole. There are 8 other brand versions of riluzole.
What is the NDC code for riluzole 50 mg/1?
The NDC (National Drug Code) for riluzole 50 mg/1 is 68462-381, listed by Glenmark Pharmaceuticals Inc., USA.