Zyflo Cr
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Questions & Answers
Side Effects & Adverse Reactions
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Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
ZYFLO CR is indicated for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older.
ZYFLO CR is not indicated for use in the reversal of bronchospasm in acute asthma attacks. Therapy with ZYFLO CR can be continued during acute exacerbations of asthma.
History
There is currently no drug history available for this drug.
Other Information
Zileuton is an orally active inhibitor of 5-lipoxygenase, the enzyme that catalyzes the formation of leukotrienes from arachidonic acid. Zileuton has the chemical name (±)-1-(1-Benzo[b]thien-2-ylethyl)-1-hydroxyurea and the following chemical structure:
zileuton
Zileuton has the molecular formula C 11H 12N 2O 2S and a molecular weight of 236.29. It is a racemic mixture (50:50) of R(+) and S(-) enantiomers. Zileuton is a practically odorless, white, crystalline powder that is soluble in methanol and ethanol, slightly soluble in acetonitrile, and practically insoluble in water and hexane. The melting point ranges from 144.2°C to 145.2°C.
ZYFLO CR (zileuton) extended-release tablets for oral administration are triple-layer tablets comprised of an immediate-release layer, a middle (barrier) layer, and an extended-release layer. ZYFLO CR tablets are oblong, film-coated tablets with one red layer between two white layers, debossed on one side with "CT2". Each tablet contains 600 mg of zileuton and the following inactive ingredients: crospovidone, ferric oxide, glyceryl behenate, hydroxypropyl cellulose, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, sodium starch glycolate, and talc.
Sources
Zyflo Cr Manufacturers
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Chiesi Usa, Inc.
![Zyflo Cr (Zileuton) Tablet, Multilayer, Extended Release [Chiesi Usa, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Zyflo Cr | Chiesi Usa, Inc.
The recommended dosage of ZYFLO CR for the treatment of patients with asthma is two 600 mg extended-release tablets twice daily, within one hour after morning and evening meals, for a total daily dose of 2400 mg. Tablets should not be chewed, cut or crushed. If a dose is missed, the patient should take the next dose at the scheduled time and not double the dose. Assess hepatic function enzymes prior to initiation of ZYFLO CR and periodically during treatment [see Contraindications (4), Warnings and Precautions (5), and Use in Specific Populations (8.7)].
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