Riluzole

What it is and how it works

Mechanism of Action The mechanism by which riluzole exerts its therapeutic effects in patients with ALS is unknown.

Indications

Riluzole tablets, USP are indicated for the treatment of amyotrophic lateral sclerosis (ALS). Riluzole is indicated for the treatment of amyotrophic lateral sclerosis (ALS)

Dosage and administration (summary)

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 ] . Measure serum aminotransferases before and during treatment with riluzole [ see Warnings and Precautions ]. Recommended dosage: 50 mg twice daily, taken at least 1 hour before or 2 hours after a meal Measure serum aminotransferases before and during treatment ( 2 , 5.1 )

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 ] . Patients with a history of severe hypersensitivity reactions to riluzole or to any of its components

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 Neutropenia: Advise patients to report any febrile illness Interstitial lung disease: Discontinue riluzole if interstitial lung disease develops Hepatic Injury Cases of drug-induced liver injury, some of which were fatal, have been reported in patients taking riluzole.

Pregnancy

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.

Storage and supply

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 6…

Source: Riluzole (Riluzole) — US FDA prescribing information, 2020-05-16, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.