Generic Name and Formulations:
Riluzole 50mg; tabs.
Covis Pharmaceuticals, Inc.
Indications for RILUTEK:
Amyotrophic lateral sclerosis (ALS).
Take on an empty stomach. 50mg every 12 hours.
Hepatic insufficiency; discontinue if ALT ≥5xULN or if jaundice develops; rechallenge not recommended. Measure LFTs before and during therapy: ALT every month for first 3 months, every 3 months for the remainder of the year, then periodically thereafter. Increased risk of neutropenia; monitor for febrile illness and obtain WBC. Perform chest radiography if respiratory symptoms develop. Females. Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended.
Caution with concomitant hepatotoxic agents (eg, allopurinol, methyldopa, sulfasalazine). Avoid excessive alcohol. May be potentiated by CYP1A2 inhibitors (eg, caffeine, phenacetin, theophylline, amitriptyline, quinolones). May be antagonized by CYP1A2 inducers (eg, cigarette smoke, charcoal-broiled food, rifampicin, omeprazole).
Asthenia, nausea, dizziness, decreased lung function, diarrhea, abdominal pain, pneumonia, vomiting, vertigo, circumoral paresthesia, anorexia, somnolence; abnormal liver function tests, neutropenia, interstitial lung disease, hypersensitivity pneumonitis.