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Zyflo Generic Name & Formulations
Legal Class
Rx
General Description
Zileuton 600mg; tabs.
Pharmacological Class
5-lipoxygenase inhibitor.
See Also
How Supplied
Tabs, CR tabs—120
Manufacturer
Generic Availability
YES
Zyflo Indications
Indications
Prophylaxis and chronic treatment of asthma.
Zyflo Dosage and Administration
Adult
Swallow whole. Take with meals and at bedtime. 600mg four times daily; max: 2400mg/day.
Children
<12yrs: not recommended.
Zyflo Contraindications
Contraindications
Active liver disease. Persistent ALT elevations ≥3xULN.
Zyflo Boxed Warnings
Not Applicable
Zyflo Warnings/Precautions
Warnings/Precautions
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.
Zyflo Pharmacokinetics
See Literature
Zyflo Interactions
Interactions
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).
Zyflo Adverse Reactions
Adverse Reactions
Sinusitis, pharyngolaryngeal pain, abdominal pain, nausea, dyspepsia, headache, rash, hypersensitivity, hepatotoxicity, upper respiratory tract infection, myalgia; neuropsychiatric events (eg, sleep disorders, behavior changes).
Zyflo Clinical Trials
See Literature
Zyflo Note
Not Applicable
Zyflo Patient Counseling
See Literature
