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Zyflo Cr Generic Name & Formulations
Legal Class
Rx
General Description
Zileuton 600mg; ext-rel tabs.
Pharmacological Class
5-lipoxygenase inhibitor.
See Also
How Supplied
Tabs, CR tabs—120
Manufacturer
Generic Availability
YES
Zyflo Cr Indications
Indications
Prophylaxis and chronic treatment of asthma.
Zyflo Cr Dosage and Administration
Adult
Swallow whole. Take within 1hr after morning and evening meals. 1200mg twice daily; max: 2400mg/day.
Children
<12yrs: not recommended.
Zyflo Cr Contraindications
Contraindications
Active liver disease. Persistent ALT elevations ≥3xULN.
Zyflo Cr Boxed Warnings
Not Applicable
Zyflo Cr 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 Cr Pharmacokinetics
See Literature
Zyflo Cr 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 Cr 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 Cr Clinical Trials
See Literature
Zyflo Cr Note
Not Applicable
Zyflo Cr Patient Counseling
See Literature
