Singulair is an oral medication that comes in tablets, chewable tablets, and granules.
What Is Singulair Used For?
The Food and Drug Administration (FDA) approved Singulair for the following main purposes:
Brand Name(s): Singulair
Administration Route(s): Oral
Drug Availability: Prescription
Therapeutic Classification: Anti-inflammatory
Available Generically: Yes
Controlled Substance: N/A
Active Ingredient: Montelukast
Dosage Form(s): Tablet, packet
Prevention and treatment of asthma in people over 1 year old Acute prevention of exercise-induced bronchoconstriction (asthma symptoms brought on by exercise) in people ages 6 and older Relief of seasonal allergic rhinitis (hay fever) in people ages 2 and older who are intolerant of or didn’t respond well to other therapies Relief of perennial (year-round) allergic rhinitis in people ages 6 and older who are intolerant of or didn’t respond well to other therapies
The FDA issued a boxed warning (also called a black box warning), its strictest warning, for serious psychiatric effects in people taking Singulair. Your healthcare provider will discuss the benefits and risks of Singular with you. If you are taking this medication, monitor for psychiatric symptoms, including, but not limited to, agitation, depression, and suicidal thoughts and behaviors.
Contact your healthcare provider immediately if you think you are experiencing a psychiatric effect while taking this medication.
How to Take Singulair
The FDA offers the following recommendations for use of oral Singulair. However, you should use the product as advised by your healthcare provider.
The FDA recommends the following:
For asthma and allergies: Take Singulair once a day in the evening. For exercise-induced bronchoconstriction: Take Singulair at least two hours before a physical activity that may trigger symptoms.
You can take Singulair with or without food. Do not take two doses at the same time or extra doses.
Oral granules for children must be given within 15 minutes of opening the package, so don’t open it until it’s time to give it to your child, which you can do in one of the following three ways:
Spoon it right into their mouth. Dissolve it in a teaspoon of cold or room-temperature formula or breast milk only. Mix it with a spoonful of applesauce, mashed carrots, rice, or ice cream (cold or at room temperature).
Storage
Follow these guidelines for storage:
Dispose of unused medication through a pharmacy or a medication disposal company. Do not open the bottle of Singulair until ready to give the first dose. Keep away from children. Keep away from moisture (such as in the bathroom). Once expired, dispose of medication. Protect from light, extreme heat, and extreme cold. Store in the airtight original container.
Off-Label Uses
Healthcare providers often prescribe Singulair off-label (for a non-FDA-approved use) for:
Atopic dermatitis (eczema) Chronic urticaria (hives) Nasal polyposis (or nasal polyps, noncancerous growths that line the sinuses or nasal passages) Aspirin-induced asthma
What Are the Side Effects of Singulair?
This is not a complete list of side effects, and others may occur. A medical professional can advise you on side effects. If you experience other effects, contact your pharmacist or a medical professional. You may report side effects to the FDA at www.fda.gov/medwatch or 800-FDA-1088.
As with other medications, Singulair can cause side effects. Let your healthcare provider know if you have any side effects that persist or worsen.
Common Side Effects
As with all medications, you may experience possible side effects while taking Singulair. Common and less severe side effects include:
Abdominal pain Cough Diarrhea Ear infection or inflammation Fever Headaches Influenza (the flu) Runny nose Sinus inflammation Sore throat Upper respiratory infection
Severe Side Effects
If you have any severe side effects, call your healthcare provider, or get medical help right away. Potentially serious side effects of Singulair include:
Allergic reactionBlistering, peeling, or shedding skinEar pain and fever Flu-like symptoms, such as rash, numbness, or a pins-and-needles feeling in the limbs, sinus pain and swelling
Stop taking the drug and get medical attention right away if you experience any of these symptoms of a drug allergy:
Difficulty breathing or swallowing Hoarseness Itching Rash or hives Swelling of the face, throat, tongue, lips, or eyes
Boxed Warning
The FDA issued a boxed warning for Singulair because of possible psychiatric side effects, including:
Aggression Agitation Anxiousness Depression Disorientation Dream abnormalities Hallucinations Insomnia (difficulty falling asleep or staying asleep) Irritability Memory impairment Obsessive-compulsive symptoms Restlessness Sleep disturbances or sleepwalking Stuttering Suicide or suicidal thoughts Tics (sudden twitches) or tremors (rhythmic muscle contractions or shaking)
Dosage: How Much Singulair Should I Take?
Modifications
Singulair doesn’t replace your rescue inhaler and won’t stop an acute asthma attack. Try to use it regularly to prevent asthma attacks from occurring.
If you experience a serious side effect, you or your provider may send a report to the FDA MedWatch Adverse Event Reporting Program or by phone (800-332-1088).
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
For treatment and prevention of asthma: For oral dosage form (tablets): Adults and children 15 years of age and older—10 milligrams (mg) once a day in the evening. Children younger than 15 years of age—Use and dose must be determined by your doctor. For oral dosage form (chewable tablets): Children 6 to 14 years of age—5 milligrams (mg) once a day in the evening. Children 2 to 5 years of age—4 mg once a day in the evening. Children younger than 2 years of age—Use and dose must be determined by your doctor. For oral dosage form (granules): Children 2 to 5 years of age—4 milligrams (mg) (one packet) once a day in the evening. Children 12 to 23 months of age—4 mg (one packet) once a day in the evening. Children younger than 12 months of age—Use and dose must be determined by your doctor. For prevention of exercise-induced bronchoconstriction: For oral dosage form (tablets): Adults and children 15 years of age and older—10 milligrams (mg) at least 2 hours before exercise. Do not take a second dose within 24 hours of your regular dose. Children younger than 15 years of age—Use and dose must be determined by your doctor. For oral dosage form (chewable tablets): Children 6 to 14 years of age—5 milligrams (mg) at least 2 hours before exercise. Do not take a second dose within 24 hours of your regular dose. Children younger than 6 years of age—Use and dose must be determined by your doctor. For perennial allergic rhinitis: For oral dosage form (tablets): Adults 15 years of age and older—10 milligrams (mg) once a day in the evening. Children younger than 15 years of age—Use and dose must be determined by your doctor. For oral dosage form (chewable tablets): Children 6 to 14 years of age—5 milligrams (mg) once a day in the evening. Children 2 to 5 years of age—4 mg once a day in the evening. Children younger than 2 years of age—Use and dose must be determined by your doctor. For oral dosage form (granules): Children 2 to 5 years of age—4 milligrams (mg) (one packet) once a day in the evening. Children 6 months to 23 months of age—4 mg (one packet) once a day in the evening. Children younger than 6 months of age—Use and dose must be determined by your doctor. For seasonal allergic rhinitis: For oral dosage form (tablets): Adults and children 15 years of age and older—10 milligrams (mg) once a day, taken in the morning or evening. Children younger than 15 years of age—Use and dose must be determined by your doctor. For oral dosage form (chewable tablets): Children 6 to 14 years of age—5 milligrams (mg) once a day, taken in the morning or evening. Children 2 to 5 years of age—4 mg once a day, taken in the morning or evening. Children younger than 2 years of age—Use and dose must be determined by your doctor. For oral dosage form (granules): Children 2 to 5 years of age—4 milligrams (mg) (one packet) once a day, taken in the morning or evening. Children younger than 2 years of age—Use and dose must be determined by your doctor.
Missed Dose
If you miss a dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one. You should not take more than one dose of Singulair in a 24-hour period.
Overdose: What Happens If I Take Too Much Singulair?
Inform your healthcare provider if you take more than the prescribed dose of Singulair.
Precautions
What Are Reasons I Shouldn’t Take Singulair?
You should not take Singulair if you are prone to, have been diagnosed with, or have a history of depression, anxiety, or suicidal thoughts and/or attempts. This medication may increase the likelihood of the boxed warning symptoms. Anyone with a predisposition or history of these symptoms should not take Singulair. Talk to your healthcare provider if you have any concerns.
If someone collapses or isn’t breathing after taking Singulair, call 911 immediately.
You may be taking other medicines for asthma together with montelukast. Do not stop taking these medicines and do not reduce the dose, even if your asthma seems better, unless you or your child are told to do so by your doctor.
Talk to your doctor or get medical care right away if:
Your or your child’s symptoms do not improve after using this medicine or if they become worse. Your short-acting inhaler does not seem to be working as well as usual and you need to use it more often.
Montelukast may cause some people to be agitated, disoriented, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Report any unusual thoughts or behaviors that trouble you or your child, especially if they are new or get worse quickly. Make sure the doctor knows if you or your child have trouble sleeping, get upset easily, or start to act reckless. Also tell the doctor if you or your child have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared.
This medicine may increase certain white blood cells (eosinophils) and may cause Churg-Strauss syndrome (blood vessel disease). This usually occurs in patients who have asthma or are taking oral steroid medicines that is being stopped or the dose is being reduced or lowered. Check with your doctor right away if you have a feeling of pins and needles, numbness in your arms or legs, flu-like symptoms, rash, or pain or swelling of the sinuses.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Also, do not take this medication if you have a hypersensitivity to montelukast or any of the product’s ingredients.
What Other Medications Interact With Singulair?
Currently, there are no medications believed to interact negatively with Singulair and are advised against using (contraindicate use).
Talk to your healthcare provider about all medications, supplements, and vitamins that you currently take. While some drugs pose minor interaction risks, others may contraindicate use or prompt careful consideration as to whether the pros of treatment outweigh the cons in your case.
What Medications Are Similar?
Similar leukotriene modifiers currently on the market include:
Accolate (zafirlukast) Zyflo (zileuton)
How Can I Stay Healthy While Taking Singulair?
In addition to following your treatment plan, you can also keep your asthma under control by avoiding contact with environmental triggers, such as secondhand smoke, mold, and dust mites, and using a peak flow meter to monitor your condition. This is a handheld device used to measure how well your lungs release air. Doing exercises that are least likely to affect your asthma can also help benefit your health.
Singulair, used in conjunction with other asthma medications, should help control your condition so that you can live a full and happy life. It’s important to talk to your healthcare provider to determine if Singulair is right for you.
