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    DEA Class; Rx

    Common Brand Names; Accolate

    •  Leukotriene Receptor Antagonists

    Leukotriene receptor antagonist (LTRA)
    Used for add-on asthma maintenance therapy in adult and pediatric patients 5 years and older; off-label use for allergic rhinitis and exercise-induced bronchospasm
    Inhibits some CYP hepatic enzymes, which may lead to drug interactions; associated with rare hepatic toxicity

    Indicated for asthma maintenance treatment.

    For exercise-induced bronchospasm prophylaxis.
    For the treatment of allergic rhinitis.


    Hepatic impairment, including cirrhosis; Cmax and AUC ~50-60% greater than those of normal adults

    • headache (12.9% in age >12 yr)
    • Abdominal pain (1.8%)
    • Infection (3.5%)
    • Nausea (3.1%)
    • Diarrhea (2.8%)
    • Generalized pain (1.8%)
    • Vomiting (1.5%)
    • Dyspepsia/gastritits (1.3%)
    • Increased ALT (1.5%)
    • Infection (4%)
    • Back pain (2%)
    • Weakness (2%)
    • Myalgia (2%)

    Increased risk of infection if age >55 yr

    Not indicated for use in the reversal of bronchospasm in acute asthma attacks, including status asthmaticus; therapy can be continued during acute exacerbations of asthma

    Coadministration of zafirlukast with warfarin results in a clinically significant increase in prothrombin time (PT); patients on oral warfarin anticoagulant therapy and this drug should have their prothrombin times monitored closely and anticoagulant dose adjusted accordingly

    Indicated for the chronic treatment of asthma; should be taken regularly as prescribed, even during symptom-free periods; this drug is not a bronchodilator and should not be used to treat acute episodes of asthma

    Patients receiving therapy should be instructed not to decrease the dose or stop taking any other antiasthma medications unless instructed by a physician

    Patients should be instructed to notify their physician if neuropsychiatric events occur while using this drug; women who are breast-feeding should be instructed not to take this medication; alternative antiasthma medication should be considered in such patients

    Bioavailability of this medication may be decreased when taken with food; patients should be instructed to take the medication at least 1 hour before or 2 hours after meals

    This medication is excreted in breast milk; following repeated 40 mg twice-a-day dosing in healthy women, average steady-state concentrations in breast milk were 50 ng/mL compared to 255 ng/mL in plasma


    40 mg/day PO.


    40 mg/day PO.


    40 mg/day PO.


    12 years: 40 mg/day PO.
    5 to 11 years: 20 mg/day PO.
    Less than 5 years: Safety and efficacy have not been established.


    Safety and efficacy have not been established.



    • 10mg
    • 20mg