Pronunciation:

mon-te-LOO-kast

Brand Names:

• Singulair

Dosage Forms:

• Tablet
• Tablet, Chewable
• Packet

Warnings:

Warning: Serious Neuropsychiatric EventsSerious neuropsychiatric (NP) events have been reported in patients taking montelukast. The types of events reported were highly variable, and included, but were not limited to, agitation, aggression, depression, sleep disturbances, suicidal thoughts and behavior (including suicide). The mechanisms underlying NP events associated with montelukast use are currently not well understood.Because of the risk of NP events, the benefits of montelukast may not outweigh the risks in some patients, particularly when the symptoms of disease may be mild and adequately treated with alternative therapies. Reserve use of montelukast for patients with allergic rhinitis who have an inadequate response or intolerance to alternative therapies. In patients with asthma or exercise-induced bronchoconstriction, consider the benefits and risks before prescribing montelukast.Discuss the benefits and risks of montelukast with patients and caregivers when prescribing montelukast. Advise patients and/or caregivers to be alert for changes in behavior or new NP symptoms when taking montelukast. If changes in behavior are observed, or if new NP symptoms or suicidal thoughts and/or behavior occur, advise patients to discontinue montelukast and contact a healthcare provider immediately .

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 allergic rhinitis (hay fever), including seasonal (short-term) or perennial (long-term) allergic rhinitis, 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 allergic rhinitis, or children 6 months of age and older with perennial allergic rhinitis. 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. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

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.

• Abiraterone Acetate
• Carbamazepine
• Dasabuvir
• Leflunomide
• Omaveloxolone
• Phenobarbital
• Pixantrone
• Teriflunomide

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) (eg, celecoxib, ibuprofen, naproxen, Advil®, Aleve®, or Motrin®)—Continue to avoid aspirin or NSAIDs while taking this medicine.

• Asthma attack, acute—Should not be used in patients with this condition.

• Depression, history of or
• Mental health problems, history of—Use with caution. May make this condition worse.

• 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 children 15 years of age and older—10 milligrams (mg) once a day in the evening.
    • Children younger than 15 years of age—Use and dose must be determined by your doctor.
  • For oral dosage form (chewable tablets):
    • Children 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.
    • Children 12 to 23 months of age—4 mg (one packet) once a day in the evening.
    • Children younger than 12 months of age—Use and dose must be determined by your doctor.
• For prevention of exercise-induced bronchoconstriction:
  • For oral dosage form (tablets):
    • Adults and children 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 younger than 15 years of age—Use and dose must be determined by your doctor.
  • For oral dosage form (chewable tablets):
    • Children 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 allergic rhinitis:
  • For oral dosage form (tablets):
    • Adults 15 years of age and older—10 milligrams (mg) once a day in the evening.
    • Children younger than 15 years of age—Use and dose must be determined by your doctor.
  • For oral dosage form (chewable tablets):
    • Children 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.
    • Children 6 months to 23 months of age—4 mg (one packet) once a day in the evening.
    • Children younger than 6 months of age—Use and dose must be determined by your doctor.
• For seasonal allergic rhinitis:
  • For oral dosage form (tablets):
    • Adults and children 15 years of age and older—10 milligrams (mg) once a day, taken in the morning or evening.
    • Children younger than 15 years of age—Use and dose must be determined by your doctor.
  • For oral dosage form (chewable tablets):
    • Children 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, 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 Churg-Strauss syndrome (blood vessel disease). This usually occurs in patients who have asthma or are taking oral steroid medicines that is being stopped or the dose is being reduced or lowered. Check with your doctor right away if you have a feeling of pins and needles, numbness in your arms or legs, flu-like symptoms, rash, or pain or swelling of the sinuses.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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:

More common

Body aches or pain

cough

difficulty in breathing

dryness or soreness of the throat

fever

headache

loss of voice

pain or tenderness around the eyes and cheekbones

pain, redness, or swelling in the ear

stomach pain

stuffy or runny nose

tender, swollen glands in neck

trouble in swallowing

unusual tiredness or weakness

voice changes

Less common

Bloody nose

general feeling of discomfort or illness

joint pain

sweating

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

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:

More common

Diarrhea

Less common

Acid or sour stomach

belching

blurred vision

change in near or distance vision

dental pain

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.