Montelukast

Asthma Management

Montelukast is used for the long-term prevention and treatment of asthma in adults and children. It helps reduce the frequency of symptoms such as wheezing, coughing, and shortness of breath. It is intended for daily use to keep asthma under control and is not used to treat sudden breathing problems or acute asthma attacks.

Exercise-Induced Bronchoconstriction

This medication is used to prevent breathing difficulties that are triggered by physical activity. It helps prevent the airways from narrowing during or after exercise in adults and children who are at least 6 years of age.

Allergy Relief

Montelukast is used to treat symptoms of allergic rhinitis, including sneezing and a runny or itchy nose. It is approved for:

• Seasonal allergies: Symptoms that occur at certain times of the year, often referred to as hay fever. For this condition, healthcare providers generally reserve montelukast for patients who do not respond well to other treatments or cannot tolerate them.
• Perennial allergies: Symptoms that occur year-round, often due to indoor triggers like pet dander, dust mites, or mold.

Blocking Leukotrienes

Montelukast works by interfering with substances in the body called leukotrienes. These are chemicals that the immune system releases when a person breathes in an allergen, such as pollen, or during physical exertion. In people with asthma or allergies, leukotrienes cause several physical reactions:

• Airway tightening: They cause the muscles around the airways to squeeze shut, making it harder to breathe.
• Inflammation: They lead to swelling and irritation in the lining of the lungs and nasal passages.
• Mucus production: They trigger the body to produce more fluid and mucus, contributing to congestion and a runny nose.

Preventing Symptoms

By blocking the action of these chemicals, montelukast helps to keep the airways open and reduces inflammation. This action helps prevent the symptoms of asthma, such as coughing and wheezing, and relieves the symptoms of seasonal or year-round allergies, such as sneezing and itchy eyes.

It is important to note that montelukast is a preventive medication. It works over time to manage the body's response to triggers and is not intended to stop an asthma attack that has already started.

Common Side Effects

• Headache
• Stomach pain or heartburn
• Tiredness or dizziness
• Fever
• Cough, sore throat, or runny nose
• Ear pain or infection
• Mild skin rash

Serious Side Effects

Contact your doctor immediately if you experience any of the following serious symptoms:

• Mental health or mood changes, including agitation, aggression, anxiety, depression, sleep problems, or suicidal thoughts
• Numbness, tingling, or a "pins and needles" sensation in the arms or legs
• Flu-like symptoms, such as fever, muscle aches, and chills
• Sinus pain or swelling
• Severe skin rash, bruising, or blistering
• Signs of liver problems, such as yellowing of the skin or eyes, dark urine, or pain in the upper right stomach area
• Difficulty breathing or swallowing

Boxed Warning: Neuropsychiatric Events

The FDA has issued a boxed warning for montelukast due to the risk of serious neuropsychiatric events. These may include agitation, aggression, anxiousness, depression, abnormal dreams, and suicidal thoughts or behaviors. These effects can occur at any time during treatment and may continue after stopping the medication. If changes in mood or behavior occur, the medication should be discontinued immediately and a healthcare professional consulted.

Not for Acute Symptoms

Montelukast is used for the long-term prevention of asthma and should not be used to treat an acute asthma attack. A fast-acting rescue inhaler must be used for sudden breathing problems. Patients should not decrease or stop other asthma medications unless directed by a healthcare provider.

Eosinophilic Conditions

Rarely, patients taking montelukast may experience a condition involving high levels of certain white blood cells (eosinophilia) and blood vessel inflammation (vasculitis). This is often associated with the reduction of oral steroid medications. Symptoms may include a flu-like illness, rash, or numbness in the arms or legs.

Aspirin Sensitivity

Patients with a known sensitivity to aspirin should continue to avoid aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs) while taking montelukast, as the medication does not prevent the respiratory reactions caused by these drugs.

Phenylketonuria (PKU)

The chewable tablet formulation contains phenylalanine, which can be harmful to individuals with phenylketonuria. Patients or caregivers should check the product labeling for specific phenylalanine content.

Pregnancy

Available data from studies in pregnant women have not identified a clear drug-associated risk of major birth defects or miscarriage. Research in animals using doses much higher than the standard human dose has not shown evidence of harm to the fetus. However, because animal studies are not always predictive of human response, montelukast should be used during pregnancy only if the potential benefit justifies the potential risk.

If you are pregnant or planning to become pregnant, you should discuss the risks and benefits of continuing or starting this medication with your healthcare provider.

Breastfeeding

Montelukast is known to be excreted in human breast milk. There is currently no information available regarding the effects of the drug on milk production or its impact on the nursing infant. Because many drugs are present in human milk, healthcare providers recommend exercising caution when using montelukast while breastfeeding. It is important to consult with a healthcare professional to determine the best course of action for your specific situation.

Available Forms

Montelukast is provided in the following oral dosage forms:

• Film-coated tablets: These are intended to be swallowed whole.
• Chewable tablets: These are designed to be chewed before swallowing.
• Oral granules: This formulation can be placed directly in the mouth or mixed with specific soft foods such as applesauce, mashed carrots, rice, or ice cream.

FDA Approval and Indications

Montelukast is approved by the U.S. Food and Drug Administration (FDA) for the following indications:

• Asthma: Chronic treatment and prevention of asthma in adults and children 12 months of age and older.
• Exercise-Induced Bronchoconstriction: Prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older.
• Allergic Rhinitis: Relief of symptoms for seasonal allergic rhinitis in patients 2 years and older, and perennial allergic rhinitis in patients 6 months and older.

Boxed Warning

In March 2020, the FDA required a Boxed Warning for montelukast, which is the agency's most serious type of warning. This warning was added because the drug is associated with serious neuropsychiatric events, including suicidal thoughts or actions. Other reported mental health side effects include agitation, aggression, depression, sleep disturbances, and hallucinations.

Regulatory Guidance for Use

Due to the risk of mental health side effects, the FDA advises that for allergic rhinitis, montelukast should be reserved for patients who have not responded adequately to other treatments, such as antihistamines or nasal steroids, or for those who cannot tolerate these alternative therapies. Healthcare providers are instructed to monitor all patients taking montelukast for any changes in behavior or mood.

Discontinuing Montelukast

Montelukast is a maintenance medication used for the long-term control of asthma and the management of allergic rhinitis. It is not a controlled substance and is not known to cause physical dependence or a clinical withdrawal syndrome when stopped.

Return of Symptoms

The main risk of stopping montelukast is that the symptoms it was treating may return or worsen. Because the drug works by blocking leukotrienes to prevent inflammation and airway constriction, discontinuing it may lead to:

• Increased asthma symptoms, such as coughing, wheezing, or shortness of breath.
• A return of seasonal or year-round allergy symptoms.
• A higher risk of exercise-induced breathing difficulties.

Medical Guidance

It is important to continue taking montelukast exactly as directed by a healthcare provider, even during periods when you feel well and have no symptoms. You should not stop taking this medication without consulting your doctor first. They will help you determine if your asthma or allergies are stable enough to discontinue treatment and may provide an alternative management plan to prevent a relapse of symptoms.