Uses
Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.
Asthma
Prevention and long-term symptomatic management of asthma in adults and pediatric patients ≥12 months of age. Efficacy for this indication demonstrated when the drug was administered in the evening.
In patients with mild persistent asthma, low doses of orally inhaled corticosteroids considered first-line agents for long-term control; alternative agents, including a leukotriene modifier (e.g., montelukast), may be used but are less effective than inhaled corticosteroids and are not preferred as initial therapy.
In patients with moderate persistent asthma, low- to medium-dose inhaled corticosteroids with a long-acting inhaled β2-agonist bronchodilator are preferred for long-term control; alternative agents, including a leukotriene modifier (e.g., montelukast), can be added to a low or medium dosage of corticosteroids, but these options are less effective.
Therapy with montelukast may be especially useful in patients who are unable or unwilling to comply with therapy using inhaled drugs (e.g., children).
Exercise-induced Bronchospasm
Has been used for the prevention of exercise-induced bronchospasm†.
Leukotriene modifiers not included as first-line agents or as alternative agents to orally inhaled β2-adrenergic agonists in current guidelines; addition of montelukast may provide additional measure of control in patients currently maintained on long-term control therapy.
Manufacturer states that montelukast should not be used as monotherapy for the prevention of exercise-induced bronchospasm.
Allergic Rhinitis
Symptomatic management of seasonal allergic rhinitis in adults and children ≥2 years of age. Efficacy for this indication demonstrated when the drug was administered in the morning or evening.
Urticaria
Has been used successfully in patients with chronic idiopathic urticaria†; beneficial when added to existing therapy.
Dosage and Administration
Administration
Oral Administration
Administer once daily without regard to meals.
Administer in the evening in patients with asthma.
May individualize time of administration in patients with seasonal allergic rhinitis.
Administer as a single dose in the evening in patients with asthma and seasonal allergic rhinitis.
Pediatric Administration
Oral granules generally are used in children 12 months to 5 years of age.
4-mg chewable tablets are used in children 2–5 years of age.
5-mg chewable tablets are used in children 6–14 years of age.
10-mg tablets are used in adolescents ≥15 years of age.
Oral Granules
Do not open packet until ready to use; administer full dose within 15 minutes of opening packet.
Administer directly in the mouth or mix with a spoonful of cold or room temperature soft food (i.e., applesauce, carrots, rice, ice cream). Granules are not intended to be dissolved in liquid for administration; however, liquids can be taken after administration of the granules. (See Stability.)
Do not store granules mixed with food for future use; discard any unused portion.
Dosage
Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.
Available as montelukast sodium; dosage expressed in terms of montelukast.
Pediatric Patients
Asthma
Oral
Children 12 months to 5 years of age: 4 mg daily.
Children 6–14 years of age: 5 mg daily.
Adolescents ≥15 years of age: 10 mg daily.
Exercise-induced Bronchospasm
Oral
Children 6–14 years of age: 5 mg daily.†
Adolescents ≥15 years of age: 10 mg daily.†
Allergic Rhinitis
Oral
Children 2–5 years of age: 4 mg daily.
Children 6–14 years of age: 5 mg daily.
Adolescents ≥15 years of age: 10 mg daily.
Adults
Asthma
Oral
10 mg daily.
Exercise-induced Bronchospasm
Oral
10 mg daily.†
Allergic Rhinitis
Oral
10 mg daily.
Urticaria
Oral
5–20 mg daily.†
Special Populations
Dosage in Hepatic Impairment
No dosage adjustment required in patients with mild to moderate hepatic impairment. Not evaluated in patients with severe hepatic impairment or hepatitis.
Dosage in Renal Impairment
No dosage adjustment required.
Geriatric Patients
No dosage adjustment required.
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