Montelukast helps to reduce inflammation and may be used to prevent asthma attacks in adults and children at least 2 years old.

Montelukast is also used to prevent exercise-induced bronchoconstriction (a narrowing of the air passages in the lungs due to exercise that is also known as exercise-induced asthma) in adults and children who are at least 6 years old.

For adults and children at least 2 years old with symptoms of seasonal or year-round (perennial) allergies, montelukast may be considered when other treatments have not worked.

If you already take montelukast regularly to prevent asthma or allergy symptoms, do not take an extra dose to treat exercise-induced bronchoconstriction.

Montelukast is not a fast-acting rescue medicine for asthma attacks and needs to be taken daily to work properly.

Montelukast was FDA approved in 1998.

Tell your doctor right away if you have signs of blood vessel inflammation: flu-like symptoms, severe sinus pain, a skin rash, numbness or a "pins and needles" feeling in your arms or legs.

Before taking this medicine

You should not use montelukast if you are allergic to it.

Tell your doctor if you have ever had:

• mental illness or psychosis; or

• asthma, or a history of severe allergic reaction (sneezing, runny or stuffy nose, wheezing, shortness of breath) after taking aspirin or another NSAID.

The chewable montelukast tablet may contain phenylalanine and could be harmful if you have phenylketonuria (PKU).

Tell your doctor if you are pregnant or breastfeeding.

Do not give this medicine to a child without a doctor's advice.

Montelukast comes as a tablet, a chewable tablet, and granules to take by mouth. Montelukast is usually taken once a day with or without food. When montelukast is used to treat asthma, it should be taken in the evening. When montelukast is used to prevent breathing difficulties during exercise, it should be taken at least 2 hours before exercise. If you are taking montelukast once a day on a regular basis, or if you have taken a dose of montelukast within the past 24 hours, you should not take an additional dose before exercising. When montelukast is used to treat allergic rhinitis, it may be taken at any time of day. Take montelukast at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take montelukast exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

If you are giving the granules to your child, you should not open the foil pouch until your child is ready to take the medication. There are several ways that you can give the granules to your child, so choose the one that works best for you and your child. You may pour all of the granules directly from the packet into your child's mouth to be swallowed immediately. You may also pour the entire packet of granules onto a clean spoon and place the spoonful of medication in your child's mouth. If you prefer, you may mix the entire packet of granules in 1 teaspoon (5 mL) of cold or room temperature baby formula, breast milk, applesauce, soft carrots, ice cream, or rice. You should not mix the granules with any other foods or liquids, but your child may drink any liquid right after he or she takes the granules. If you mix the granules with one of the allowed foods or drinks, use the mixtures within 15 minutes. Do not store unused mixtures of food, formula, or breast milk and the medication.

Do not use montelukast to treat a sudden attack of asthma symptoms. Your doctor will prescribe a short-acting inhaler to use during attacks. Talk to your doctor about how to treat symptoms of a sudden asthma attack. If your asthma symptoms get worse or if you have asthma attacks more often, be sure to call your doctor.

If you are taking montelukast to treat asthma, continue to take or use all other medications that your doctor has prescribed to treat your asthma. Do not stop taking any of your medications or change the doses of any of your medications unless your doctor tells you that you should. If your asthma is made worse by aspirin, do not take aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) during your treatment with montelukast.

Montelukast controls the symptoms of asthma and allergic rhinitis but does not cure these conditions. Continue to take montelukast even if you feel well. Do not stop taking montelukast without talking to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Take montelukast exactly as prescribed by your doctor and read all medication guides or instruction sheets about montelukast.

Montelukast is not a fast-acting rescue medicine for asthma attacks. Seek medical attention if your breathing problems get worse quickly, or if you think your medications are not working.

Montelukast is usually taken once every evening, with or without food.

For exercise-induced bronchoconstriction, take a single dose at least 2 hours before exercise, and do not take another dose for at least 24 hours.

Swallow the regular tablet whole, with a glass of water.

You must chew the chewable tablet before you swallow it.

Place the oral granules directly in your mouth and swallow, or mix them with applesauce, mashed carrots, rice, or ice cream. The granules may also be mixed with baby formula or breast milk. Do not use any other type of liquid. Use the mixture within 15 minutes. Do not save for later use.

If you also use an oral steroid medication, you should not stop using it suddenly when you start taking montelukast. Follow your doctor's instructions about tapering your dose.

Do not change your dose or stop using asthma medication without your doctor's advice.

Store montelukast at room temperature away from moisture and heat. Do not open a packet of montelukast oral granules until you are ready to use them.

You should not use montelukast if you are allergic to it.

Tell your doctor if you have ever had:

• mental illness or psychosis; or

• asthma, or a history of severe allergic reaction (sneezing, runny or stuffy nose, wheezing, shortness of breath) after taking aspirin or another NSAID.

The chewable montelukast tablet may contain phenylalanine and could be harmful if you have phenylketonuria (PKU).

Tell your doctor if you are pregnant or breastfeeding.

Do not give this medicine to a child without a doctor's advice.

If you miss a dose of montelukast, skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light and excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Avoid situations or activities that may trigger an asthma attack.

If your asthma symptoms get worse when you take aspirin, avoid taking aspirin or other NSAIDs (nonsteroidal anti-inflammatory drugs) such as ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

Get emergency medical help if you have signs of an allergic reaction to montelukast: hives, blisters, severe itching; difficult breathing; swelling of your face, lips, tongue, or throat.

Tell your doctor right away if you have signs of blood vessel inflammation: flu-like symptoms, severe sinus pain, a skin rash, numbness or a "pins and needles" feeling in your arms or legs.

Some people using montelukast have had new or worsening mental problems. Stop taking montelukast and call your doctor right away if you have unusual changes in mood or behavior, such as:

• agitation, aggression, feeling restless or irritable;

• anxiety, depression, confusion, problems with memory or attention;

• stuttering, tremors, uncontrolled muscle movements;

• suicidal thoughts or actions;

• hallucinations, sleep problems, vivid, dreams, sleep-walking; or

• compulsive or repetitive behaviors.

Common side effects of montelukast may include:

• stomach pain, diarrhea;

• fever or other flu symptoms;

• ear pain or full feeling, trouble hearing;

• headache; or

• cold symptoms such as runny or stuffy nose, sinus pain, cough, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may affect montelukast, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.