Riluzole
Generic Name: riluzole
Brand Names:
Riluzole
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.
Overview
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.
Uses
1 INDICATIONS AND USAGE Riluzole tablets is indicated for the treatment of amyotrophic lateral sclerosis (ALS). Riluzole tablets is indicated for the treatment of amyotrophic lateral sclerosis (ALS) ( 1 )
Dosage
2 DOSAGE AND ADMINISTRATION The recommended dosage for riluzole tablets is 50 mg taken orally twice daily. Riluzole tablets 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 tablets [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 )
Side Effects
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 AvKARE at 1-855-361-3993 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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 Co-administration 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.
Warnings
5 WARNINGS AND PRECAUTIONS Hepatic injury: Use of riluzole tablets is not recommended in patients with baseline elevations of serum aminotransferases greater than 5 times upper limit of normal; discontinue Riluzole tablets if there is evidence of liver dysfunction ( 5.1 ) Neutropenia: Advise patients to report any febrile illness ( 5.2 ) Interstitial lung disease: Discontinue Riluzole tablets if interstitial lung disease develops ( 5.3 ) 5.1 Hepatic Injury Cases of drug-induced liver injury, some of which were fatal, have been reported in patients taking riluzole tablets. Asymptomatic elevations of hepatic transaminases have also been reported, and in some patients have recurred upon rechallenge with riluzole tablets. 4 CONTRAINDICATIONS Riluzole tablets 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 )] . Patients with a history of severe hypersensitivity reactions to riluzole tablets or to any of its components ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary There are no studies of riluzole in pregnant women, and case reports have been inadequate to inform the drug-associated risk. The background risk for major birth defects and miscarriage in patients with amyotrophic lateral sclerosis is unknown. In the U.S. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Riluzole Tablets, USP 50 mg are white to off-white, film-coated, capsule-shaped and engraved with “795” on one side, plain on the other. Riluzole is supplied in bottles of 60 tablets, NDC 42291-775-60. Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. Protect from bright light.
Frequently Asked Questions
What is Riluzole used for?▼
1 INDICATIONS AND USAGE Riluzole tablets is indicated for the treatment of amyotrophic lateral sclerosis (ALS). Riluzole tablets is indicated for the treatment of amyotrophic lateral sclerosis (ALS) ( 1 )
What are the side effects of Riluzole?▼
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 AvKARE at 1-855-361-3993 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Can I take Riluzole during pregnancy?▼
8.1 Pregnancy Risk Summary There are no studies of riluzole in pregnant women, and case reports have been inadequate to inform the drug-associated risk. The background risk for major birth defects and miscarriage in patients with amyotrophic lateral sclerosis is unknown. In the U.S. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
What are the important warnings for Riluzole?▼
5 WARNINGS AND PRECAUTIONS Hepatic injury: Use of riluzole tablets is not recommended in patients with baseline elevations of serum aminotransferases greater than 5 times upper limit of normal; discontinue Riluzole tablets if there is evidence of liver dysfunction ( 5.1 ) Neutropenia: Advise patients to report any febrile illness ( 5.2 ) Interstitial lung disease: Discontinue Riluzole tablets if interstitial lung disease develops ( 5.3 ) 5.1 Hepatic Injury Cases of drug-induced liver injury, some of which were fatal, have been reported in patients taking riluzole tablets. Asymptomatic elevations of hepatic transaminases have also been reported, and in some patients have recurred upon rechallenge with riluzole tablets. 4 CONTRAINDICATIONS Riluzole tablets 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 )] . Patients with a history of severe hypersensitivity reactions to riluzole tablets or to any of its components ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.