Riluzole Medication Summary
No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication?
Riluzole is described in FDA/DailyMed prescribing information. No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication used for?
Riluzole tablets, USP are indicated for the treatment of amyotrophic lateral sclerosis (ALS).
What should I know before taking it?
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)].
What important warnings are listed?
5 WARNINGS AND PRECAUTIONS Hepatic injury: Use of riluzole is not recommended in patients with baseline elevations of serum aminotransferases greater than 5 times upper limit of normal; discontinue riluzole if there is evidence of liver dysfunction (5.1) Neutropenia: Advise patients to report any febrile illness (5.2) Interstitial lung disease: Discontinue riluzole 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. Asymptomatic elevations of hepatic transaminases have also been reported, and in some patients have recurred upon rechallenge with riluzole. In clinical.
How is this medication usually taken?
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)]. Tablets: 50 mg white to off white colored, round-shaped, biconvex film-coated tablets and debossed with “538” on one side and plain on other side.
What side effects are listed?
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) ]
What interactions are listed?
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.,.
Where can I find the official prescribing information?
Review the full prescribing information on DailyMed: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4c851be4-f0d0-4b24-baf9-427ddfc6f7b0
⚠️ Disclaimer
This summary is for educational purposes only and is not medical advice. Always consult your doctor, pharmacist, or other licensed healthcare professional before starting, stopping, or changing any medicine. Read full medical disclaimer.