These highlights do not include all the information needed to use ZYFLO CR® safely and effectively. See full prescribing information for ZYFLO CR.
ZYFLO CR (zileuton) extended-release tablets
Initial U.S. Approval: 1996
INDICATIONS AND USAGE
ZYFLO CR 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 ZYFLO CR to treat an acute asthma attack. (1) DOSAGE AND ADMINISTRATION
Adults and children 12 years of age and older: The recommended dose of ZYFLO CR 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 ZYFLO CR and monitor periodically during treatment. (2, 5.1) DOSAGE FORMS AND STRENGTHS
Active liver disease or persistent hepatic function enzyme elevations ≥3 times the upper limit of normal. (4, 5.1)
History of allergic reaction to zileuton or any of the ingredients of ZYFLO CR. (4)
WARNINGS AND PRECAUTIONS
Hepatotoxicity: Elevations of one or more hepatic function enzymes and bilirubin may occur with ZYFLO CR. Assess hepatic function enzymes prior to initiation of ZYFLO CR, monthly for the first 3 months, every 2-3 months for the remainder of the first year, and periodically thereafter. Use ZYFLO CR with caution in patients who consume substantial quantities of alcohol and/or have a history of liver disease. (5.1)
Neuropsychiatric Events: Neuropsychiatric events, including sleep disorders and behavior changes, may occur with ZYFLO CR. Instruct patients to be alert for neuropsychiatric events. eva luate the risks and benefits of continuing treatment with ZYFLO CR if such events occur. (5.2)
ADVERSE REACTIONS
Most common adverse reactions (≥5%) included: sinusitis, nausea, and pharyngolaryngeal pain. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Chiesi USA, Inc. at 1-888-661-9260 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Zileuton increases warfarin levels. Monitor prothrombin time and adjust warfarin dose accordingly. (7.2)
Zileuton increases propranolol levels and beta-blocker activity. Monitor appropriately. (7.3)
USE IN SPECIFIC POPULATIONS
Hepatic Impairment: ZYFLO CR is contraindicated in patients with active liver disease and in patients with elevated hepatic function enzymes ≥3 times the upper limit of normal. (4, 5, 8.7)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Sections or subsections omitted from the full prescribing information are not listed.
1 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.
2 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 (8.7)].
3 DOSAGE FORMS AND STRENGTHS
Extended-release tablets, 600 mg.
4 CONTRAINDICATIONS
The use of ZYFLO CR is contraindicated in patients with:
Active liver disease or persistent hepatic function enzyme elevations greater than or equal to 3 times the upper limi
