Montelukast

Montelukast

Side Effects

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
  • Body aches or pain
  • Chills
  • Colds
  • Congestion
  • Cough or hoarseness
  • Cough producing mucus
  • Diarrhea
  • Difficulty with breathing
  • Dryness or soreness of the throat
  • Fever
  • Flu-like symptoms
  • General feeling of discomfort or illness
  • Headache
  • Joint pain
  • Loss of appetite
  • Muscle aches and pains
  • Nausea
  • Pain or tenderness around the eyes and cheekbones
  • Shivering
  • Shortness of breath or troubled breathing
  • Sneezing
  • Stuffy or runny nose
  • Sweating
  • Tender or swollen glands in the neck
  • Tightness of the chest or wheezing
  • Trauma
  • Trouble with sleeping
  • Trouble with swallowing
  • Unusual tiredness or weakness
  • Voice changes
  • Vomiting
  • Weakness

Rare

  • Pus in the urine

Incidence not known

  • Aggression
  • Agitation
  • Anxiety
  • Attempts at killing oneself
  • Bloating
  • Breathing problems
  • Clay-colored stools
  • Confusion about identity, place, and time
  • Constipation
  • Convulsions (seizures)
  • Dark-colored urine
  • Discouragement
  • Dry mouth
  • Fast, irregular, pounding, or racing heartbeat or pulse
  • Feeling sad or empty
  • General tiredness and weakness
  • Hives or welts
  • Indigestion
  • Irritability
  • Itching, puffiness, or swelling of the eyelids or around the eyes, face, lips, or tongue
  • Lack of appetite
  • Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • Light-colored stools
  • Loss of bladder control
  • Loss of interest or pleasure
  • Muscle spasm or jerking of all extremities
  • Nervousness
  • Pains in the stomach, side, or abdomen, possibly moving to the back
  • Redness of the skin
  • Restlessness
  • Seeing, hearing, or feeling things that are not there
  • Shakiness in the legs, arms, hands, or feet
  • Shaking or trembling of the hands or feet
  • Sleeplessness
  • Sudden loss of consciousness
  • Tiredness
  • Trouble with breathing
  • Trouble with concentrating
  • Unable to sleep
  • Unpleasant breath odor
  • Upper right abdominal 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
  • Difficulty in focusing the eyes
  • Earache
  • Heartburn
  • Lack or loss of strength
  • Pain
  • Redness
  • Redness or swelling in the ear
  • Skin rash, encrusted, scaly and oozing
  • Stomach discomfort, upset, or pain
  • Swelling
  • Tenderness
  • Warmth on the skin

Incidence not known

  • Burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
  • Difficulty with moving
  • Dreams that are unusual
  • Increased tendency to bleed
  • Large, flat, blue or purplish patches on the skin
  • Muscle aching or cramping
  • Muscle pain or stiffness
  • 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.

Precautions

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 together with montelukast. Do not stop taking these medicines and do not reduce the dose, even if your asthma seems better, unless you are told to do so by your doctor.

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.

Proper Use

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.

For patients taking the oral granule form of this medicine—It may be taken on a full or empty stomach. The 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 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 seasonal or perennial allergies or 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 6 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 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. If you use this medicine for asthma or allergies, 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.

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

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

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.

Before Using

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.

Pediatric

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

Geriatric

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

Pregnancy

Pregnancy Category Explanation
All Trimesters B Animal 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.

Breastfeeding

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.

Drug Interactions

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 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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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 non-steroidal anti-inflammatory drugs (NSAIDs) (e.g., ibuprofen, naproxen, Advil®, Aleve®, or Motrin®)—Continue to avoid aspirin or NSAIDs while taking this medicine.
  • Liver disease—Effects may be increased because of slower removal of montelukast from the body.
  • Phenylketonuria (PKU)—The chewable tablets contain aspartame, which can make this condition worse.

Description

Montelukast is used for 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 asthma attacks, and to treat the 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.

Leave a Reply