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Drug Catalog - Product Detail

ZILEUTON EXTENDED RELEASE TABS 600MG 120CT

NDC Mfr Size Str Form
66993-0485-32 PRASCO LABORATORIES 120 600MG TABLET
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Description
11 DESCRIPTION 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 11 H 12 N 2 O 2 S 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 144.2ºC to 145.2ºC. 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. Zileuton Extended-Release 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. zileuton
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Zileuton Extended-Release Tablets are debossed on one side with “CT2”; they are available in bottles of 120 tablets (NDC 66993-485-32). Store between 20 and 25°C (68 - 77ºF); excursions permitted to 15 - 30°C (59 - 86ºF). [see USP Controlled Room Temperature]. Protect from light.
Indications & Usage
1 INDICATIONS AND USAGE Zileuton Extended-Release Tablets is indicated for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older. Zileuton Extended-Release Tablets is not indicated for use in the reversal of bronchospasm in acute asthma attacks. Therapy with Zileuton Extended-Release Tablets can be continued during acute exacerbations of asthma. Zileuton Extended-Release Tablets is a leukotriene synthesis inhibitor indicated for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older. ( 1 ) Do not use Zileuton Extended-Release Tablets to treat an acute asthma attack. ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION The recommended dosage of Zileuton Extended-Release Tablets 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 Zileuton Extended-Release Tablets and periodically during treatment [see Contraindications ( 4 ), Warnings and Precautions ( 5 ), and Use in Specific Populations ( 8.7 ) ]. Adults and children 12 years of age and older: The recommended dose of Zileuton Extended-Release Tablets 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. ( 2 ) Monitoring: Assess hepatic function enzymes prior to initiation of Zileuton Extended-Release Tablets and monitor periodically during treatment. ( 2 , 5.1 )