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Montelukast (Oral route)

Pronunciation:

mon-te-LOO-kast

Brand Names:

  • Singulair

Dosage Forms:

  • Tablet, Chewable
  • Tablet
  • Packet

Classifications:

Therapeutic—

Anti-Inflammatory

Pharmacologic—

Leukotriene Pathway Inhibitor

Uses of This Medicine:

Montelukast is used to treat and prevent asthma. It will decrease the symptoms 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 prevent exercise-induced bronchoconstriction (EIB), and treat symptoms of seasonal (short-term) or perennial (long-term) allergies, such as sneezing, runny nose, itching, or wheezing.

This medicine is available only with your doctor's prescription.

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 this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of montelukast in children 1 year of age and older with asthma, children 6 years of age and older with exercise-induced bronchoconstriction, children 2 years of age and older with seasonal allergies, or children 6 months of age and older with perennial allergies. Safety and efficacy have not been established in children below these age groups.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of montelukast in the elderly.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersBAnimal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Clozapine
  • Pixantrone

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Gemfibrozil
  • Prednisone

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Grapefruit Juice

Other medical problems—

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

  • Allergy to aspirin or
  • Allergy to nonsteroidal anti-inflammatory drugs (NSAIDs) (e.g., celecoxib, ibuprofen, naproxen, Advil®, Aleve®, or Motrin®)—Continue to avoid aspirin or NSAIDs while taking this medicine.
  • Phenylketonuria (PKU)—The chewable tablets contain aspartame, which can make this condition worse.

Proper Use of This Medicine:

Use this medicine only as directed by your doctor. Do not use more of it and do not use it more often, unless otherwise directed by your doctor.

This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

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 inhaled medicine. If you do not have an inhaled medicine to use for an attack, or if you have any questions about this, check with your doctor.

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

You may take this medicine with or without food.

For patients taking the oral granules:

  • Open the packet until you are ready to use it.
  • The oral granules may either be swallowed whole, or dissolved in 1 teaspoonful (5 mL) of cold or room temperature baby formula or breast milk, or mixed with a spoonful of soft food, such as applesauce, carrots, rice, or ice cream. The oral granules should not be chewed. Do not mix this medicine with any other liquid other than baby formula or breast milk.
  • The mixed medicine must be given within 15 minutes and must not be stored for future use.

Dosing—

The dose of this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

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 teenagers 15 years of age and older—10 milligrams (mg) once a day in the evening.
      • Children and teenagers younger than 15 years of age—Use and dose must be determined by your doctor.
    • For oral dosage form (chewable tablets):
      • Children and teenagers 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.
      • Infants 12 to 23 months of age—4 mg (one packet) once a day in the evening.
      • Infants younger than 12 months of age—Use and dose must be determined by your doctor.
  • For prevention of exercise-induced asthma:
    • For oral dosage form (tablets):
      • Adults and teenagers 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 and teenagers younger than 15 years of age—Use and dose must be determined by your doctor.
    • For oral dosage form (chewable tablets):
      • Children and teenagers 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 allergies:
    • For oral dosage form (tablets):
      • Adults and teenagers 15 years of age and older—10 milligrams (mg) once a day in the evening.
      • Children and teenagers younger than 15 years of age—Use and dose must be determined by your doctor.
    • For oral dosage form (chewable tablets):
      • Children and teenagers 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.
      • Infants 6 months to 23 months of age—4 mg (one packet) once a day in the evening.
      • Infants younger than 6 months of age—Use and dose must be determined by your doctor.
  • For seasonal allergies:
    • For oral dosage form (tablets):
      • Adults and teenagers 15 years of age and older—10 milligrams (mg) once a day, taken in the morning or evening.
      • Children and teenagers younger than 15 years of age—Use and dose must be determined by your doctor.
    • For oral dosage form (chewable tablets):
      • Children and teenagers 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 of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Store the chewable tablets, oral granules, and tablets in its original package or container.

Precautions While Using This Medicine:

If you will be taking this medicine for a long time, it is very important that your doctor check you or your child at regular visits. This will allow your doctor to see if the medicine is working properly and to check for any unwanted effects.

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 systemic vasculitis. Check with your doctor right away if you have a feeling of numbness in your arms or legs, flu-like symptoms, rash, or pain or swelling of the sinuses.

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 immediately if any of the following side effects occur:

Less common
Abdominal or stomach pain
bloody nose
flu-like symptoms
general feeling of discomfort or illness
headache
joint pain
pain or tenderness around the eyes and cheekbones
shortness of breath or troubled breathing
sweating
tightness of the chest
trouble with swallowing
unusual tiredness or weakness
Rare
Pus in the urine
Incidence not known
Agitation
anxiety
attempts at killing oneself
breathing problems
confusion about identity, place, and time
constipation
fast, irregular, pounding, or racing heartbeat or pulse
feeling sad or empty
hives or welts
indigestion
itching, puffiness, or swelling of the eyelids or around the eyes, face, lips, or tongue
lack of appetite
pains in the stomach, side, or abdomen, possibly moving to the back
redness of the skin
shaking or trembling of the hands or feet
trouble with concentrating
unable to sleep
unpleasant breath odor
upper right abdominal or stomach pain
vomiting of blood
yellow eyes or skin

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common
Acid or sour stomach
belching
blurred vision
change in near or distance vision
dental pain
earache
heartburn
lack or loss of strength
pain
skin rash, encrusted, scaly and oozing
stomach discomfort, upset, or pain
Incidence not known
Burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
dreams that are unusual
increased tendency to bleed
large, flat, blue or purplish patches on the skin
muscle aching or cramping
sleepiness
swollen joints

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.


Last Updated: 11/4/2014

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