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

Extended-release tablets: 600 mg (3)

CONTRAINDICATIONS

• 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 Cornerstone Therapeutics at 1-888-661-9260 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

• Zileuton increases theophylline levels. Reduce theophylline dose and monitor levels. (7.1)
• 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)

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Hepatotoxicity

5.2 Neuropsychiatric Events

6 ADVERSE REACTIONS