Generic Name and Formulations:
Zileuton 600mg; ext-rel tabs.
Chiesi USA, Inc.
Prophylaxis and chronic treatment of asthma.
Swallow whole. 1200mg twice daily.
Active liver disease. Persistent ALT elevations ≥3xULN.
Not for primary treatment of acute attacks. Monitor liver function before initiating therapy, monthly for the 1st 3 months, every 2–3 months for the remainder of the year, and periodically thereafter (discontinue if signs/symptoms occur). History of liver disease. Alcohol consumption. Evaluate if neuropsychiatric events occur. Pregnancy (Cat.C). Nursing mothers: not recommended.
Potentiates theophylline (reduce dose of theophylline by about ½). Potentiates warfarin, propranolol (possibly other β-blockers); monitor and adjust doses. Monitor concomitant CYP3A4 inhibitors (eg, ketoconazole).
Sinusitis, pharyngolaryngeal pain, abdominal pain, nausea, dyspepsia, headache, rash, hypersensitivity, hepatotoxicity, upper respiratory tract infection, myalgia; neuropsychiatric events (eg, sleep disorders, behavior changes).
Hepatic (CYP1A2, CYP 2C9, CYP3A4).
Renal (major), fecal (minor).
Tabs, CR tabs—120