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    DEA Class; Rx

    Common Brand Names; Singulair

    • Leukotriene Receptor Antagonists

    Oral leukotriene receptor antagonist (LRTA) class anti-inflammatory agent
    Used for mild persistent asthma (age 1 year and older); seasonal allergic rhinitis (2 years and older), perennial allergic rhinitis (6 months and older); and exercise-induced bronchoconstriction (EIB) prophylaxis (6 years and older)
    Boxed warning for serious neuropsychiatric effects; only use in allergic rhinitis patients intolerant to or not responding to other treatments

    Indicated for prophylaxis and chronic treatment of asthma

    Indicated for prevention of exercise-induced bronchoconstriction (EIB)

    Indicated for symptomatic relief of seasonal or perennial allergic rhinitis


    • Some adverse drug reactions vary by age group
    • Headache (18.4%; similar to placebo)
    • Abdominal pain (≥2%)
    • Eczema (≥2%)
    • Influenza (≥2%)
    • Laryngitis (≥2%)
    • Pharyngitis (≥2%)
    • Viral infection (≥2%)
    • Wheezing (≥2%)
    • Dental pain (2%)
    • Dizziness (2%)
    • Dyspepsia (2%)
    • Elevated liver function tests (2%)
    • Fever (2%)
    • Gastroenteritis (2%)
    • Nasal congestion (2%)
    • Otitis (2%)
    • Rash (2%)
    • Urticaria (2%)
    • Bronchitis (≥1%)
    • Cough (≥1%)
    • Sinusitis (≥1%)
    • Upper respiratory tract infection (≥1%)

    Not to be given for acute asthma attacks, including status asthmaticus

    Advise patients to have appropriate rescue medication available

    Inhaled corticosteroid may be reduced gradually; do not abruptly substitute montelukast for inhaled or oral corticosteroids

    Patients with known aspirin sensitivity should continue to avoid aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) while taking montelukast; not to be given for treatment of bronchoconstriction resulting from aspirin or NSAID intake

    Neuropsychiatric events reported, including agitation, aggressive behavior or hostility, anxiousness, depression, disorientation, disturbance in attention, dream abnormalities, hallucinations, insomnia, irritability, memory impairment, restlessness, somnambulism, suicidal thinking and behavior (including suicide), tic, and tremor; prescribers should carefully evaluate the risks and benefits of continuing treatment if such events occur

    Systemic eosinophilia reported, sometimes presenting with clinical features of vasculitis consistent with Churg-Strauss syndrome; these events are usually (but not always) associated with tapering of PO corticosteroid therapy

    Use with caution in phenylketonuria; 4-mg and 5-mg chewable tablets contain phenylalanine; before prescribing to a patient with PKU, consider combined daily amount of phenylalanine from all sources, including amount in drug

    Available data from published prospective and retrospective cohort studies over decades in pregnant women have not established a drug-associated risk of major birth defects

    A published clinical lactation study reports presence of montelukast in human milk; data available on effects of drug on infants, either directly or through breast milk, do not suggest a significant risk of adverse events from exposure


    10 mg/day PO.


    10 mg/day PO.


    15 years and older: 10 mg/day PO.
    13 to 14 years: 5 mg/day PO.


    6 to 12 years: 5 mg/day PO.
    1 to 5 years: 4 mg/day PO.


    6 months and older: 4 mg/day PO for perennial allergic rhinitis only.
    Less than 6 months: Safety and efficacy have not been established.

    Montelukast sodium 


    • 10mg

    tablet, chewable

    • 4mg
    • 5mg

    oral granules

    • 4mg/packet