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All about: Montelukast

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Some commonly used brand names are:

In the U.S.—

  • Singulair


  • Antiasthmatic, leukotriene receptor antagonist


Montelukast (mon-te-LOO-kast) is used in mild to moderate asthma to decrease the symptoms of asthma and the number of acute asthma attacks. However, this medicine should not be used to relieve an asthma attack that has already started. This medicine is also used to treat the symptoms (sneezing, runny nose, itching, wheezing) of seasonal (short-term) allergies.

This medicine is available only with your doctor's prescription, in the following dosage form:

  • Oral
  • Tablets (U.S.)
  • Chewable tablets (U.S.)
  • Oral granules (U.S.)

Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For montelukast, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to montelukast. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Montelukast has not been studied in pregnant women. However, it has been studied in animals and has not been found to cause birth defects or other problems. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known whether montelukast passes into breast milk in humans. However, it does pass into breast milk in animals. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are using this medicine and who wish to breast-feed should discuss this with their doctor.

Children—No information is available regarding use of montelukast in infants younger than 12 months of age.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. There is no specific information comparing use of montelukast in the elderly with its use in other age groups. However, it has been used in some elderly patients and no differences in effectiveness or side effects were seen from those that occurred in younger adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are taking or using any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other medical problems—The presence of other medical problems may affect the use of montelukast. Make sure you tell your doctor if you have any other medical problems, especially:

  • Allergy to aspirin or non-steroidal anti-inflammatory agents (NSAIDs) (etodolac [e.g., Lodine], ibuprofen [e.g., Advil, Motrin], ketoprofen [e.g., Orudis], naproxen [e.g., Aleve])—Patients should continue to avoid aspirin or NSAIDs while taking montelukast.
  • Liver disease—Effects of montelukast may be increased because of slower removal from the body
  • Phenylketonuria (PKU)—The chewable tablets may contain aspartame, which can make your condition worse.

Proper Use of This Medicine

Montelukast is used to prevent asthma attacks. It is not used to relieve an attack that has already started. For relief of an asthma attack that has already started, you should use another medicine. If you do not have another medicine to use for an attack or if you have any questions about this, check with your health care professional.

For patients taking the oral granule form of this medicine—May be taken on a full or empty stomach. Packet of oral granules may either be swallowed whole or mixed with a spoonful of soft food such as applesauce, carrots, rice or ice cream. The oral granules should not be chewed.

Dosing—The dose of montelukast will be different for different patients. Follow your doctor's orders or the directions on the label . The following information includes only the average doses of montelukast. If your dose is different, do not change it unless your doctor tells you to do so.

The number of tablets or the amount of oral granules 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 taking montelukast. For asthma the dose should be taken once a day in the evening.

  • For asthma or seasonal allergies:
    • For tablets dosage form:
      • Adults and children 15 years of age and over—10 milligrams (mg) once a day.
    • For chewable tablets dosage form:
      • Children 6 to 14 years of age—5 mg once a day.
      • Children 2 to 5 years of age—4 mg once a day.
    • For oral granules dosage form:
      • Children 2 to 5 years of age—4 mg (one packet) once a day.
      • Infants 12 to 23 months of age—4 mg (one packet) once a day.
      • Infants younger than 12 months of age—Use and dose must be determined by your doctor.

Missed dose—If you miss a dose of this medicine, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—To store this medicine:

  • Keep out of the reach of children.
  • Store away from heat and direct light.
  • Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
  • Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

To work properly, montelukast must be taken every day at the same time, even if your asthma seems better.

Do not stop taking montelukast, even if your asthma seems better, unless you are told to do so by your doctor.

Check with your doctor if your symptoms do not improve or if your asthma gets worse.

You may be taking other medicines for asthma along with montelukast. Do not stop taking or reduce the dose of the other medicines, even if your asthma seems better, unless you are told to do so by your doctor.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if the following side effect occurs:


Pus in the urine

Incidence not determined

Abdominal or stomach pain; anxiety; assault; attack; bloating; chills; clay-colored stools; constipation; convulsions; darkened urine; diarrhea; difficulty swallowing; dry mouth; fast, irregular, pounding, or racing heartbeat or pulse; force; general tiredness and weakness; hives or welts; hyperventilation; indigestion; irregular heartbeats; irritability; itching; itching, puffiness, or swelling of the eyelids or around the eyes, face, lips or tongue; itching skin; large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs; light-colored stools; loss of appetite; loss of bladder control; muscle spasm or jerking of all extremities; nausea; nervousness; pains in stomach, side, or abdomen, possibly radiating to the back; redness of skin; restlessness; seeing, hearing, or feeling things that are not there; shaking; shortness of breath; sudden loss of consciousness; tightness in chest; trouble sleeping; unpleasant breath odor; upper right abdominal pain; unusual tiredness or weakness; vomiting; vomiting of blood; wheezing; yellow eyes or skin

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

More common


Less common

Abdominal or stomach pain; cough; dental pain; dizziness; fever; heartburn; skin rash; stuffy nose; weakness or unusual tiredness

Incidence not determined

Burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings; difficulty in moving; dream abnormalities; increased bleeding tendency; irritability; joint pain; large, flat, blue or purplish patches in the skin; muscle aching or cramping; muscle pain or stiffness; sleepiness; sleeplessness; swelling; swollen joints; trouble sleeping; unable to sleep

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Developed: 08/12/1998
Revised: 11/09/2004

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