Montelukast

The most common side effects with montelukast are:

• headache,
• dizziness,
• abdominal pain,
• sore throat, and
• rhinitis (inflammation of the inner lining of the nose).

Other important side effects include:

• wheezing,
• cough,
• rash,
• restlessness,
• tremor, and
• nausea.

Elevated liver enzymes, suicidal behavior, fluid retention, depression, and hallucinations have also been reported.

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Do not take montelukast if you are allergic to any of its ingredients.

Montelukast may cause serious side effects.

• Behavior and mood-related changes. Tell your doctor right away if you have mood-related changes.
• Increase in certain white blood cells (eosinophils) and possible inflamed blood vessels throughout the body (systemic vasculitis). Rarely, this can happen in people with asthma who take montelukast. This usually, but not always, happens in people who also take a steroid medicine by mouth that is being stopped or the dose is being lowered. 

If you have asthma and aspirin makes your asthma symptoms worse, continue to avoid taking aspirin or other medicines called non-steroidal anti-inflammatory drugs (NSAIDs) while taking montelukast.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if monelukast crosses into human breast milk. Because of the potential for serious harm in nursing infants from monelukast, a decision should be made whether to discontinue nursing or to discontinue montelukast, taking into account the importance of the medication to the mother.

(mon te LOO kast)

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Packet, Oral:

Singulair: 4 mg (30 ea)

Generic: 4 mg (1 ea, 30 ea)

Tablet, Oral:

Singulair: 10 mg

Generic: 10 mg

Tablet Chewable, Oral:

Singulair: 4 mg, 5 mg [contains aspartame]

Generic: 4 mg, 5 mg

• Leukotriene-Receptor Antagonist

Chronic urticaria

Data from controlled, double-blind trials regarding the use of montelukast in combination with antihistamines for the management of chronic urticaria are conflicting. Based on clinical practice guidelines from the American Academy of Allergy, Asthma and Immunology (AAAAI); the American College of Allergy, Asthma, and Immunology (ACAAI); the Joint Council of Allergy, Asthma and Immunology (JCAAI); and the World Allergy Organization for the diagnosis and management of acute and chronic urticaria, a leukotriene receptor antagonist may be added to antihistamine therapy in patients who do not respond to antihistamines. Access Full-Off Label Monograph

Urticaria (nonsteroidal anti-inflammatory drug–induced)

Data from a double-blind, placebo-controlled comparison of montelukast and cetirizine in patients with chronic urticaria and intolerance to food additives and/or aspirin supports the use of montelukast in the treatment of patients experiencing urticaria related to the use of nonsteroidal anti-inflammatory drugs [Pacor 2001].

Refer to adult dosing.

When treating asthma, administer dose in the evening. Patients with allergic rhinitis may individualize administration time (morning or evening). Patients with both asthma and allergic rhinitis should take a single dose in the evening. May administer without regard to food or meals.

Granules: May be administered directly in the mouth, dissolved in 5 mL of baby formula or breast milk, or mixed with a spoonful of applesauce, carrots, rice, or ice cream; do not add to any other liquids or foods. Administer within 15 minutes of opening packet.

-10 mg orally once a day

Comments:
-For asthma, efficacy has been demonstrated when this drug was administered in the EVENING without regard to time of food ingestion.
-For allergic rhinitis, efficacy has been demonstrated for asthma when this drug was administered in the MORNING or EVENING without regard to time of food ingestion.
-Patients with both asthma and allergic rhinitis should take only one dose daily in the evening.

Uses:
-Prophylaxis and chronic treatment of asthma
-Relief of symptoms of seasonal allergic rhinitis and perennial allergic rhinitis

Safety and efficacy have not been established in patients younger than 12 months, for asthma; in younger than 2 years, for allergic rhinitis; and in younger than 6 years, for exercise induced bronchoconstriction (EIB).

Consult WARNINGS section for additional precautions.

Administration advice:
-Patients with both asthma and allergic rhinitis should take only one dose daily in the evening.
-This drug can be taken with or without food.
-Oral granules: Administer within 15 minutes after opening the sachet (with or without mixing with food).

Storage requirements:
-Protect from moisture and light.
-Store in original package.

Reconstitution/preparation techniques: The manufacturer product information should be consulted for the oral granules formulation.

General:
-Daily administration for the chronic treatment of asthma has not been established to prevent acute episodes of EIB.

Patient advice:
-Take this drug daily as prescribed, even when asymptomatic and during periods of worsening asthma; the physician should be contacted if asthma is not well controlled.
-Appropriate short-acting inhaled beta-agonist medication should be available to treat asthma exacerbations.
-Seek medical attention if short-acting inhaled bronchodilators are needed more often than usual, or if more than the maximum number of inhalations of short-acting bronchodilator for a 24-hour period is needed.
-Report occurrence of neuropsychiatric events while using this drug.
-Patients should not decrease the dose or stop taking any other anti-asthma medications unless instructed by a physician.
-Patients with known aspirin sensitivity should continue avoiding aspirin or non-steroidal anti-inflammatory agents while taking this drug.

Substance Name

Montelukast

CAS Registry Number

158966-92-8

Drug Class

Anti-Asthmatic Agents

Leukotriene Antagonists