Drug Notebook

FDA Alerts

Special Alerts:

[Posted 03/27/2008] FDA informed healthcare professionals and patients of the Agency's investigation of the possible association between the use of montelukast (Singulair) and behavior/mood changes, suicidality (suicidal thinking and behavior) and suicide. Montelukast is a leukotriene receptor antagonist used to treat asthma and the symptoms of allergic rhinitis, and to prevent exercise-induced asthma. Patients should not stop taking montelukast before talking to their doctor if they have questions about the new information. Healthcare professionals and caregivers should monitor patients taking montelukast for suicidality (suicidal thinking and behavior) and changes in behavior and mood.

This early communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs. Due to the complexity of the analyses, FDA anticipates that it may take up to 9 months to complete the ongoing evaluations. As soon as this review is complete, FDA will communicate the conclusions and recommendations to the public. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Singulair and http://www.fda.gov/cder/drug/early_comm/montelukast.htm.

Media Gallery
Drug Info Tools
Pill Finder
Search by color, shape and markings. click here
Drug Interaction Checker
Check any 2 drugs for interactions. click here
Drug Compare
Compare any two drugs side by side. click here
Healthline Part D Plan Selector Medicare Part D
Medicare's drug plans are subsidized by the US federal government and offered through insurers.
Advertisement
Marketplace
Licensed from
montelukast
(mon the LOO kast)

What is montelukast?
Montelukast is a leukotriene (loo-koe-TRY-een) inhibitor. Leukotrienes are chemicals your body releases when you breathe in an allergen (such as pollen). These chemicals cause swelling in your lungs and tightening of the muscles around your airways, which can result in asthma symptoms. Montelukast is used to prevent asthma attacks in adults and children as young as 12 months old. It is also used to relieve runny nose and sneezing caused by allergies in adults and children as young as 6 months old.

Back to Top

What is the price of this medication and similar alternatives?

This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Singulair 10MG Tablets MERCK HUMAN HEALTH30/$112.25 or 90/$324.01
Singulair 4MG Chewable Tablets MERCK HUMAN HEALTH30/$108.01 or 90/$312.36
Singulair 4MG Pack MERCK HUMAN HEALTH30/$116.48 or 90/$337.78
Singulair 5MG Chewable Tablets MERCK HUMAN HEALTH30/$105.99 or 90/$305.97

Back to Top

What are the possible side effects of montelukast?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • skin rash, bruising, severe tingling, numbness, pain, muscle weakness;

  • mood or behavior changes, anxiety, depression, or thoughts about suicide or hurting yourself;

  • tremors or shaking;

  • severe sinus pain, swelling, or irritation; or

  • worsening asthma symptoms.

Less serious side effects may include:

  • upset stomach, nausea, diarrhea;

  • mouth pain;

  • tired feeling;

  • dizziness, headache;

  • sore throat, cough, hoarseness; or

  • stuffy nose.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

Back to Top

How should I take montelukast?
Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label. Montelukast is usually taken once daily in the evening for prevention of asthma or allergy symptoms. For exercise-induced bronchoconstriction, take a single dose at least 2 hours before you exercise, and do not take another dose for at least 24 hours. Follow your doctor's instructions.

Back to Top

What is the most important information I should know about montelukast?
Do not use montelukast to treat an asthma attack that has already begun. It will not work fast enough to reverse your symptoms. Use only a fast-acting inhalation medication to treat an asthma attack. Talk with your doctor if any of your asthma medications do not seem to work as well in treating or preventing asthma attacks. It may take up to several weeks of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after several weeks of treatment.

Back to Top

What happens if I miss a dose?
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

Back to Top

What other drugs will affect montelukast?
Before using montelukast, tell your doctor if you are using any of the following drugs: phenobarbital (Luminal, Solfoton); or rifampin (Rifadin, Rifater, Rifamate, Rimactane). This list is not complete and there may be other drugs that can interact with montelukast. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Back to Top

Can I take this if I am pregnant or trying to get pregnant or if I am breastfeeding?

Montelukast has been assigned to pregnancy category B by the FDA. Animal data have failed to reveal evidence of teratogenicity. There are no controlled data in human pregnancy. Montelukast is only recommended for use during pregnancy when benefit outweighs risk.

There are no data on the excretion of montelukast into human milk. The manufacturer recommends that caution be used when administering montelukast the nursing women.

Back to Top

Who should NOT use this medication?

  • Known hypersensitivity to montelukast or any ingredient in the formulation.

Back to Top

What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of a montelukast overdose are not known.

Back to Top

What should I discuss with my healthcare provider before taking montelukast?
Do not use this medication if you are allergic to montelukast. Before using montelukast, tell your doctor if you are allergic to any drugs (especially aspirin), or if you have liver disease. You may not be able to use montelukast, or you may need dosage adjustments or special tests during treatment. The chewable tablet form of this medication may contain up to 0.842 milligrams of phenylalanine. Talk to your doctor before using this form of montelukast if you have phenylketonuria (PKU). FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Back to Top

Can I stop taking the medication if I feel better?
As a general rule, you should always take your medications exactly as prescribed and do not change the dosage or stop taking the medication without first discussing it with your healthcare provider.

Back to Top

I am on so many medications; do I have to take them all?
This is called polypharmacy—many different medications being used at the same time by one person. Sometimes, being on multiple medications is acceptable and appropriate but at other times it may be problematic. If you are receiving your medications from multiple physicians you need to ensure that they all know what medications you are taking. The best way to do this is to make a list of all the medications you are currently using, including all nutritional supplements, homeopathic remedies, vitamins and over-the-counter drugs (if possible, also include all the diseases you have been diagnosed with). Give a copy to every doctor who takes care of you so they have it on file, this way they can avoid duplicating medications and perhaps even try to consolidate some. After every doctor's visit remember to update the list accordingly. Also, as much as you possibly can, try to use the same pharmacy to fill all your prescriptions, this way any potential drug interactions can be caught and averted.

Back to Top

Where can I get more information?
More Information

Back to Top

Back to Top