General Information

Accolate (zafirlukast) is a synthetic, selective peptide leukotriene receptor antagonist (LTRA).

Accolate is specifically indicated for the prophylaxis and chronic treatment of asthma in adults and children 5 years of age and older.

Accolate is supplied as a tablet for oral administration. Accolate should be taken at least 1 hour before or 2 hours after meals. The recommended dose of Accolate in adults and children 12 years and older is 20 mg twice daily.  The recommended dose of Accolate in children 5 through 11 years of age is 10 mg twice daily.

Mechanism of Action

Zafirlukast is a selective and competitive receptor antagonist of leukotriene D4 and E4 (LTD4 and LTE4), components of slow reacting substance of anaphylaxis (SRSA). Cysteinyl leukotriene production and receptor occupation have been correlated with the pathophysiology of asthma, including airway edema, smooth muscle constriction, and altered cellular activity associated with the inflammatory process, which contribute to the signs and symptoms of asthma. 

Side Effects

Adverse effects associated with the use of Accolate may include, but are not limited to, the following:

• headache
• diarrhea
• nausea
• pharyngitis
• abdominal pain

Clinical Trial Results

The FDA approval of Accolate was based on three U.S. double-blind, randomized, placebo-controlled, 13-week clinical trials in 1,380 adults and children 12 years of age and older with mild-to-moderate asthma. Data demonstrated that Accolate improved daytime asthma symptoms, nighttime awakenings, mornings with asthma symptoms, rescue beta2-agonist use, FEV1, and morning peak expiratory flow rate. In these trials, improvement in asthma symptoms occurred within one week of initiating treatment with Accolate. 

Additional Information

For additional information regarding Accolate or asthma, please visit AstraZeneca's website.