Singulair

Asthma Management

Singulair is used for the long-term prevention and treatment of asthma in adults and children at least 12 months old. It helps reduce the frequency and severity of asthma symptoms such as wheezing, coughing, and shortness of breath. It is important to note that this medication is not a rescue inhaler and should not be used to treat a sudden asthma attack.

Exercise-Induced Bronchoconstriction

This medication is prescribed to prevent exercise-induced bronchoconstriction, which is the narrowing of the airways in the lungs triggered by physical activity. For this purpose, it is used in adults and children who are at least 6 years old.

Allergy Relief

Singulair is used to treat symptoms of allergic rhinitis, including sneezing, stuffy nose, runny nose, and itching. It is approved for:

• Seasonal allergies: For adults and children at least 2 years old who have symptoms during specific times of the year (hay fever).
• Perennial allergies: For adults and children at least 6 months old who have year-round symptoms.

Because of the risk of serious mental health side effects, healthcare providers typically prescribe Singulair for allergic rhinitis only when other common allergy treatments are not effective or cannot be tolerated.

Mechanism of Action

Singulair belongs to a class of medications called leukotriene receptor antagonists. It works by blocking the action of leukotrienes, which are natural chemicals the body releases when you breathe in an allergen or during physical exertion.

How Leukotrienes Affect the Body

Leukotrienes play a significant role in the body's inflammatory response. When these chemicals are active in the respiratory system, they cause:

• Inflammation: Swelling of the lining of the airways.
• Bronchoconstriction: Tightening of the muscles surrounding the airways.
• Mucus buildup: Increased production of fluid and mucus in the lungs.

By preventing leukotrienes from binding to their receptors, Singulair helps to reduce these reactions. This process helps keep the airways open, making it easier to breathe and reducing symptoms associated with asthma and allergic rhinitis. Because it works by preventing the inflammatory response over time, it is used for daily maintenance rather than for the immediate relief of an acute asthma attack.

Common Side Effects

Many people using Singulair experience mild side effects. These may include:

• Headache
• Stomach pain, heartburn, or diarrhea
• Tiredness or dizziness
• Cough, sore throat, or fever
• Flu-like symptoms

Serious Side Effects

Contact a healthcare provider immediately if you experience any of the following serious symptoms:

• Mental health changes: This includes agitation, aggression, anxiety, depression, confusion, or abnormal dreams.
• Sleep disturbances: Difficulty sleeping or walking in your sleep.
• Suicidal thoughts: Any thoughts about hurting yourself or ending your life.
• Allergic reactions: Swelling of the face, lips, tongue, or throat; severe skin rash; or hives.
• Neurological symptoms: Numbness, tingling, or a "pins and needles" sensation in the arms or legs.
• Respiratory issues: New or worsening sinus pain or swelling.
• Muscle issues: Unexplained muscle weakness.

Boxed Warning: Mental Health Risks

The FDA has issued a boxed warning for Singulair due to the risk of serious mental health side effects. These neuropsychiatric events can occur in adults and children and may happen during treatment or after the medication is stopped. Symptoms may include:

• Agitation, aggression, or hostility
• Anxiety, depression, or confusion
• Disorientation or memory problems
• Sleep disturbances, including vivid dreams, sleepwalking, or insomnia
• Suicidal thoughts or actions

If any changes in mood or behavior are noticed, the medication should be discontinued immediately and a healthcare provider should be contacted.

Acute Asthma Treatment

Singulair is not a rescue medication. It is intended for the long-term prevention of asthma symptoms and should not be used to treat a sudden asthma attack or acute bronchospasm. A fast-acting rescue inhaler must be used for immediate relief of symptoms.

Eosinophilic Conditions

In rare instances, patients with asthma treated with Singulair may develop a condition characterized by high levels of eosinophils and blood vessel inflammation (vasculitis). This often occurs when oral steroid dosages are being decreased. Symptoms may include a flu-like illness, rash, or numbness in the arms or legs.

Aspirin Sensitivity

Patients with known aspirin sensitivity should continue to avoid aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) while taking Singulair. Although Singulair helps manage asthma, it does not prevent severe reactions to aspirin in sensitive individuals.

Phenylketonuria (PKU)

The chewable tablet form of Singulair contains phenylalanine. Individuals with phenylketonuria should be aware of this ingredient, as it requires restricted intake in their diet.

Pregnancy

Information regarding the use of Singulair during pregnancy is limited. While animal studies have not shown a high risk of birth defects, there are no comprehensive studies in humans to confirm its safety. Healthcare providers typically recommend using this medication during pregnancy only when the potential benefit justifies the potential risk to the fetus.

Breastfeeding

It is currently unknown if Singulair passes into human breast milk or how it might affect a nursing child. Because of this uncertainty, it is important to talk to a doctor before breastfeeding while taking this medication. They can help evaluate the necessity of the drug for the mother versus the potential risks to the infant.

If you are pregnant, planning to become pregnant, or breastfeeding, you should discuss your treatment options with your medical team to ensure the safest approach for your specific situation.

Available Forms

Singulair is provided in the following oral preparations:

• Oral Tablets: These are film-coated tablets intended to be swallowed whole.
• Chewable Tablets: These tablets are designed to be chewed thoroughly before swallowing.
• Oral Granules: This formulation consists of a packet of granules that can be taken directly in the mouth or mixed with specific soft foods or liquids, such as applesauce, mashed carrots, rice, ice cream, baby formula, or breast milk.

FDA Approval and Indications

Singulair (montelukast) is approved by the U.S. Food and Drug Administration (FDA) for several respiratory conditions. It is used for the long-term prevention and treatment of asthma in adults and children as young as 12 months old. It is also approved to prevent exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older.

For allergy management, the FDA has approved Singulair to treat symptoms of seasonal allergic rhinitis in patients 2 years and older, and perennial allergic rhinitis in patients 6 months and older. However, for allergic rhinitis, the FDA recommends that Singulair only be used when other treatments are not tolerated or have not worked well.

Boxed Warning

In 2020, the FDA required a Boxed Warning—the agency's most serious type of warning—to be added to the prescribing information for Singulair. This warning highlights the risk of serious neuropsychiatric events, which include changes in mood, behavior, and suicidal thoughts or actions.

The FDA determined that the risks of these mental health side effects may outweigh the benefits for some patients, particularly those with mild symptoms of allergic rhinitis. Healthcare providers are advised to monitor patients for signs of behavioral changes and to stop the medication immediately if these symptoms occur.

Regulatory History and Safety Monitoring

The FDA has monitored reports of mental health side effects associated with Singulair for many years. In 2017, the FDA identified a potential signal of serious risk regarding neuropsychiatric events through its Adverse Event Reporting System (FAERS). This ongoing evaluation eventually led to the strengthened warnings and the requirement for a Medication Guide to be provided to patients with every prescription.

How Singulair Works for Asthma

Singulair (montelukast) is a leukotriene receptor antagonist used for the long-term prevention of asthma symptoms in adults and children as young as 12 months old. The medication works by blocking the action of leukotrienes, which are natural chemicals the body releases when breathing in a trigger. These chemicals cause swelling in the lungs and tightening of the muscles around the airways, which can lead to asthma symptoms.

Important Usage Guidelines

For asthma management, Singulair is typically taken once daily in the evening. It is important to follow these safety and usage guidelines:

• Maintenance only: Singulair is not a rescue medication and will not stop an asthma attack that has already started. Patients must always have a fast-acting rescue inhaler available for sudden breathing problems.
• Consistency: The medication must be taken every day as prescribed, even if asthma symptoms are not present.
• Exercise-induced asthma: While Singulair can help prevent breathing problems during exercise, patients should consult their doctor about the specific timing of doses for this purpose.

Boxed Warning and Safety

The FDA has issued a boxed warning for Singulair due to the risk of serious mental health side effects. These can include mood changes, aggression, agitation, sleep disturbances, and suicidal thoughts or actions. Healthcare providers should be notified immediately if any changes in behavior or mood occur while taking this medication.