Montelukast, commonly sold under the brand name Singulair, is a prescription medication widely used to manage asthma and allergy symptoms. While generally effective, it's crucial to be aware of its potential side effects, including concerns about weight gain or loss, and the more serious mental health risks highlighted by the FDA's boxed warning.
What is Montelukast and How Does It Work?
Montelukast is a leukotriene receptor antagonist. It works by blocking leukotrienes, substances in the body that cause inflammation, airway constriction, and mucus production. By blocking these substances, montelukast helps to improve asthma symptoms and control allergy symptoms such as sneezing, stuffy, runny, and itchy nose. This makes it suitable for long-term asthma management and relieving seasonal allergy symptoms. Montelukast is also used to prevent exercise-induced bronchoconstriction.
Montelukast is available as Singulair and as generic montelukast in several oral dosage forms:
- 4 mg chewable tablets
- 5 mg chewable tablets
- 4 mg oral granules
- 10 mg oral tablets
It is important to note that montelukast will not stop a sudden asthma attack. Always have a rescue inhaler with you for asthma attacks.
Common Uses of Montelukast
Montelukast is primarily used for:
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- Long-term treatment of asthma in adults and children.
- Prevention of exercise-induced asthma symptoms. The dose should be taken at least 2 hours before exercise. If you are taking montelukast every day for asthma or allergies, do not take an extra dose to prevent exercise-induced asthma and do not take more than one dose in 24 hours.
- Control of allergy symptoms, such as sneezing, stuffy nose, runny nose, and itchy nose.
- Treating symptoms of allergic rhinitis in adults and children ages 15 years and older who either can’t use other treatments or who didn’t get enough relief from other treatments.
Storage Information
Montelukast should be stored at room temperature, between 68°F to 77°F (20°C to 25°C). It can be exposed to temperatures between 59°F to 86°F (15°C to 30°C) for shorter periods, such as during transport. Store it in a cool, dry place in the original package and protect it from light. Keep montelukast out of the reach of children.
Common and Serious Side Effects of Montelukast
Like all medications, montelukast can cause side effects. It is essential to be aware of both the common and serious side effects and to contact your healthcare provider if you experience any bothersome symptoms.
Common Side Effects
The most common side effects of montelukast include:
- Upper respiratory infection, sinus infection, and flu
- Fever
- Headache
- Stomach pain
- Diarrhea
- Earache or ear infection
- Sore throat, cough, runny nose
Serious Side Effects
While less common, the serious side effects of montelukast require immediate medical attention. These include:
- Severe Allergic Reactions: Montelukast may cause allergic reactions, which can be serious. Stop taking montelukast and get help right away if you have any of the following symptoms of a serious allergic reaction:
- Breathing problems or wheezing
- Racing heart
- Fever or general ill feeling
- Swollen lymph nodes
- Swelling of the face, lips, mouth, tongue, or throat
- Trouble swallowing or throat tightness
- Itching, skin rash, or pale red bumps on the skin called hives
- Nausea or vomiting
- Dizziness, feeling lightheaded, or fainting
- Stomach cramps
- Joint pain
- Mental Health Problems: Montelukast carries a boxed warning regarding the risk of serious behavior or mood changes. Montelukast may cause new or worsened mental health issues that affect your mood, thoughts, feelings, behavior, and general well-being. These effects can occur in people with or without a prior history of mental health problems and may continue even after stopping montelukast. Stop taking montelukast and call your healthcare provider immediately if you have any of the following symptoms:
- Unusual changes in your mood, behavior, or thinking
- Feeling agitated, confused, irritable, depressed, confused, or anxious
- Bad or vivid dreams
- Hallucinations
- Memory or attention problems
- Obsessive-compulsive behavior
- Restlessness
- Sleepwalking or trouble sleeping
- New or increased thoughts of suicide or death
- Suicide attempt
- Stuttering or stammering
- Tremors or uncontrolled muscle movements
- Eosinophilia and Systemic Vasculitis: Montelukast can increase certain white blood cells called eosinophils and cause swelling of the blood vessels throughout the body, a condition called systemic vasculitis. This can also occur in people who take oral steroid medicines when the medicine is being stopped or the dose is being lowered. Tell your healthcare provider right away if you have any of the following symptoms:
- Feeling of pins and needles or numbness of the arms or legs
- Flu-like symptoms
- Rash
- Pain and swelling of the sinuses
- Liver Problems: Though rare, more serious liver problems, including liver injury, have been reported since the drug was approved for use. However, most serious liver side effects occurred in people with preexisting risk factors for liver problems, such as hepatitis and heavy alcohol consumption. Symptoms of liver problems can include:
- Jaundice
- Abdominal pain or swelling
- Itchy skin
- Dark-colored urine
- Pale-colored stool
- Thrombocytopenia: A low level of platelets in your blood.
Montelukast and Weight Changes: What the Evidence Says
Many individuals considering or currently taking montelukast wonder about its potential impact on their weight. It's important to address this concern with the available evidence. Weight gain and weight loss are not expected side effects of montelukast. These weight changes weren’t reported side effects in the drug’s clinical trials.
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Why Weight Concerns Arise
The concern about weight changes with montelukast may stem from the fact that some other asthma treatments, particularly oral steroids, are known to cause weight gain. However, montelukast is not a steroid.
Potential Indirect Effects
While montelukast itself doesn't directly cause weight gain, its effectiveness in managing asthma symptoms might indirectly influence weight. If montelukast works well to treat your asthma symptoms, it may become easier to exercise. This could lead to weight loss. However, in most cases, this weight loss shouldn’t be severe. If you experience unexplained weight loss, contact your doctor. They can help determine what may be causing your weight loss.
When to Seek Medical Advice
Any unexplained or significant weight changes should be discussed with a healthcare provider. They can evaluate potential underlying causes and provide appropriate guidance.
Precautions and Warnings
Before taking montelukast, inform your healthcare provider about all your health conditions and medications. In particular, discuss:
- Allergies: Do not take montelukast if you are allergic to montelukast, Singulair, or any of the ingredients in the specific product dispensed.
- Current and Past Health Conditions:
- A history of mental health problems
- Aspirin allergy
- Phenylketonuria: Montelukast chewable tablets contain aspartame, a source of phenylalanine, which may be harmful if you have phenylketonuria.
- Pregnancy: It is not known if or how montelukast could affect pregnancy or harm an unborn baby. Tell your healthcare provider if you are or plan to become pregnant.
- Breastfeeding: It is not known if montelukast passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Your healthcare provider will advise you if you should take montelukast while breastfeeding.
- Sensitivity to Aspirin: Aspirin and certain nonsteroidal anti-inflammatory drugs (NSAIDs) can trigger asthma symptoms in some people.
- Liver Problems: Since montelukast was approved for use, there have been rare reports of liver problems.
Interactions
Food and Drinks
There are no known interactions between montelukast and foods or drinks. It is unknown if drinking alcohol will affect montelukast. If you drink alcohol, your doctor may advise limiting your intake while taking montelukast. While there are no specific interactions between montelukast and alcohol, both can cause liver problems.
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Drug Interactions
There are no known interactions between montelukast and other medicines. Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.
Addressing Concerns and Seeking Support
The reports of mental health side effects associated with montelukast have led to increased awareness and caution. If you or a loved one experiences any unusual mood or behavior changes while taking montelukast, it is crucial to seek medical advice immediately.
The FDA Boxed Warning
Montelukast has a boxed warning for the risk of serious behavior or mood changes. This is a serious warning from the FDA. It alerts doctors and patients about drug effects that may be dangerous. Psychiatric and mental health side effects reported since montelukast was approved include:
- Unusual aggression, irritability, or hostility
- Depression
- Anxiety
- Disorientation
- Difficulty paying attention
- Memory problems
- Hallucinations
- Stuttering
- Sleep problems, including insomnia, sleepwalking, and unusual dreams
- Suicidal thoughts or behaviors
In most cases, these reactions happened during treatment with montelukast. However, it’s possible for symptoms to appear for the first time after you stop treatment.
What to Do If You Experience Side Effects
- Contact Your Doctor: Immediately tell your doctor if you notice any changes in your behavior or mood while taking montelukast.
- Monitor Symptoms: Keep track of any side effects you experience and share this information with your doctor.
- Seek Professional Help: If you experience severe mental health symptoms, seek help from a mental health professional.
- Consider Alternative Treatments: Discuss alternative treatment options with your doctor if the side effects of montelukast are intolerable.
Dosage and Administration
Montelukast is available in various forms and dosages to accommodate different age groups and needs. The typical dosages are:
- Adults and adolescents (15 years and older): 10 mg tablet once daily in the evening.
- Children (6-14 years): 5 mg chewable tablet once daily in the evening.
- Children (2-5 years): 4 mg chewable tablet or oral granules once daily in the evening.
Montelukast can be taken with or without food. Follow the Instructions for Use that come with montelukast granules for how to prepare and give the dose to your child.
Montelukast Brands and Nicknames
Singulair’s primary brand name is Singulair, manufactured by Merck. The generic name for Singulair is montelukast, and it may be sold under this name by various pharmaceutical companies. There are no widely known nicknames for Singulair, but it is often referred to simply by its generic name, montelukast, in medical and pharmacy settings.
How Long Does Singulair Stay in Your System?
Singulair (montelukast) has a half-life of approximately 2.7 to 5.5 hours, meaning it takes this amount of time for the concentration of the drug in the bloodstream to reduce by half. Based on this half-life, Singulair is typically eliminated from the system within 24 to 48 hours after the last dose. However, factors such as age, liver function, and metabolism can influence how quickly it is processed and cleared from the body.
Montelukast Efficacy and Uses
Singulair (montelukast) is an effective medication primarily used to prevent asthma attacks and manage symptoms of chronic asthma, as well as seasonal or year-round allergies, such as sneezing, runny nose, and nasal congestion. It works by blocking leukotrienes, chemicals that cause inflammation, airway constriction, and mucus production. Singulair is also used to prevent exercise-induced bronchospasm and is particularly effective in improving breathing and reducing asthma-related symptoms when taken consistently. However, it is not suitable for immediate relief of acute asthma attacks. Seasonal allergic rhinitis and exercise-induced bronchoconstriction (EIB) may require chronic treatment for symptoms like sinus pain.