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Brand Names: Singulair

Generic Name: montelukast (Pronunciation: mon the LOO kast)

• What is montelukast (Singulair)?
• What are the possible side effects of montelukast (Singulair)?
• What is the most important information I should know about montelukast (Singulair)?
• What should I discuss with my healthcare provider before taking montelukast (Singulair)?
• How should I take montelukast (Singulair)?
• What happens if I miss a dose (Singulair)?
• What happens if I overdose (Singulair)?
• What should I avoid while taking montelukast (Singulair)?
• What other drugs will affect montelukast (Singulair)?
• Where can I get more information?

What is montelukast (Singulair)?

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.

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

Montelukast is also used to prevent exercise-induced bronchoconstriction (narrowing of the air passages in the lungs) in people who are not already taking this medicine for other conditions.

If you already take this medication to prevent asthma or allergy symptoms, do not use it for exercise-induced bronchoconstriction.

Montelukast may also be used for other purposes not listed in this medication guide.

Singulair 10 mg

square, beige, imprinted with SINGULAIR, MRK 117

Singulair 4 mg chewable

oval, pink, cherry, imprinted with SINGULAIR, MRK 711

Singulair 5 mg

round, pink, cherry, imprinted with SINGULAIR, MRK 275

What are the possible side effects of montelukast (Singulair)?

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:

• headache;
• stomach pain, heartburn, upset stomach, nausea, diarrhea;
• tooth pain;
• tired feeling;
• fever, stuffy nose, sore throat, cough, hoarseness; or
• mild rash.

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.

What is the most important information I should know about montelukast (Singulair)?

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.

Call your doctor right away if you feel that this medicine is not working as well as usual, or if it makes your condition worse. If it seems like you need to use more of any of your medications in a 24-hour period, talk with your doctor.

If you already take this medication to prevent asthma or allergy symptoms, do not use it for exercise-induced bronchoconstriction.

Call your doctor at once if you have any mood or behavior changes, anxiety, depression, or thoughts about suicide or hurting yourself.

What should I discuss with my healthcare provider before taking montelukast (Singulair)?

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). You may need a dose adjustment or special tests to safely use this medication.

The chewable tablet form of this medication may contain 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.

It is not known whether montelukast passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take montelukast (Singulair)?

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.

If you already take this medication to prevent asthma or allergy symptoms, do not use it for exercise-induced bronchoconstriction.

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

The chewable tablet must be chewed completely before you swallow it.

The oral granules can be placed directly into the mouth and swallowed, or mixed with a spoonful of applesauce, mashed carrots, rice, or ice cream. Oral granules can also be mixed with 1 teaspoon of baby formula or breast milk. Do not use any other type of liquid for mixing the granules. Other liquids can be taken before or after taking the medicine.

After opening or mixing the oral granules, you must use them within 15 minutes. Do not save an open packet or mixed medicine for later use.

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.

Asthma is often treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Be sure to read the medication guide or patient instructions provided with each of your medications. Do not change your doses or medication schedule without advice from your doctor, even if you have no asthma symptoms.

If you also take a steroid asthma medicine, do not stop using it suddenly without first talking to your doctor. You may need to use less and less before you stop the medication completely.

Call your doctor right away if you feel that this medicine is not working as well as usual, or if it makes your condition worse. If it seems like you need to use more of any of your medications in a 24-hour period, talk with your doctor.

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

What happens if I miss a dose (Singulair)?

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.

What happens if I overdose (Singulair)?

Seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of a montelukast overdose are not known.

What should I avoid while taking montelukast (Singulair)?

Avoid situations or activities that may trigger an asthma attack.

What other drugs will affect montelukast (Singulair)?

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.

Where can I get more information?

Your pharmacist can provide more information about montelukast.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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