Montelukast

DEA Class; Rx

Common Brand Names; Singulair

• Leukotriene Receptor Antagonists

Hypersensitivity

• 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

Montelukast sodium 

tablet

• 10mg

tablet, chewable

• 4mg
• 5mg

oral granules

• 4mg/packet