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ZYFLO CR
Asthma/COPD
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Drug Name:

ZYFLO CR Rx

Generic Name and Formulations:
Zileuton 600mg; ext-rel tabs.

Company:
Chiesi USA, Inc.

Therapeutic Use:

Indications for ZYFLO CR:

Prophylaxis and chronic treatment of asthma.

Adult:

Swallow whole. 1200mg twice daily.

Children:

Not recommended.

Contraindications:

Active liver disease. Persistent ALT elevations ≥3xULN.

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.

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).

See Also:

ZYFLO

Pharmacological Class:

5-lipoxygenase inhibitor.

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).

Metabolism:

Hepatic (CYP1A2, CYP 2C9, CYP3A4).

Elimination:

Renal (major), fecal (minor).

Generic Availability:

NO

How Supplied:

Tabs, CR tabs—120

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