Zyflo CR (Zileuton) - Indications and Dosage

INDICATIONS AND USAGE

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.

DOSAGE AND ADMINISTRATION

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 ].

DOSAGE FORMS AND STRENGTHS

Extended-release tablets, 600 mg

HOW SUPPLIED/STORAGE AND HANDLING

ZYFLO CR (zileuton) extended-release tablets are debossed on one side with "CT2"; they are available in bottles of 120 tablets (NDC 68734-710-10).

Store between 20 and 25°C (68-77ºF); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from light.