Riluzole (4 brand names, 3 dosage forms, 1 route)
Available dosage forms: SUSPENSION, TABLET, FILM.
Routes of administration: ORAL.
Brand Names
- EXSERVAN
- RILUTEK
- RILUZOLE
- TIGLUTIK KIT
Indications and Usage
Riluzole tablets is indicated for the treatment of amyotrophic lateral sclerosis (ALS).
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)].
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)].
Warnings and Precautions
Hepatic Injury 5.2 Neutropenia 5.3 Interstitial Lung Disease
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)]
Drug Interactions
Agents that may Increase Riluzole Blood Concentrations 7.2 Agents that may Decrease Riluzole Plasma Concentrations 7.3 Hepatotoxic Drugs
Overdosage
Reported symptoms of overdose following ingestion of riluzole ranging from 1.5 to 3 grams (30 to 60 times the recommended dose) included acute toxic encephalopathy, coma, drowsiness, memory loss, and methemoglobinemia. No specific antidote for the treatment of riluzole overdose is available. For current information on the management of poisoning or overdosage, contact the National Poison Control Center at 1-800-222-1222 or www.poison.org.