Subscribe
Submit an Article to Pharmacy HQ     
Please include the author's name, title, and citations.     

MONTELUKAST SODIUM granuleMONTELUKAST SODIUM tablet, chewableMONTELUKAST SODIUM- montelukast tablet, chewableMONTELUKAST SODIUM tablet, coated


  1. Patient Information
  2. What Is Montelukast Sodium?
  3. Montelukast Sodium Is Used To:
  4. Who Should Not Take Montelukast Sodium?
  5. Before Taking Montelukast Sodium, Tell Your Healthcare Provider If You:
  6. For Anyone Who Takes Montelukast Sodium:
  7. Montelukast Sodium 4-mg Oral Granules Can Be Given:
  8. The Dose Of Montelukast Sodium Prescribed For You Or Your Childs Condition Is Based On Age:
  9. What Should I Avoid While Taking Montelukast Sodium?
  10. What Are The Possible Side Effects Of Montelukast Sodium?
  11. Active Ingredient:
  12. Inactive Ingredients:

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Information for Patients

  • Patients should be advised to take montelukast sodium daily as prescribed, even when they are asymptomatic, as well as during periods of worsening asthma, and to contact their physicians if their asthma is not well controlled.
  • Patients should be advised that oral montelukast sodium is not for the treatment of acute asthma attacks. They should have appropriate short-acting inhaled -agonist medication available to treat asthma exacerbations. Patients who have exacerbations of asthma after exercise should be instructed to have available for rescue a short-acting inhaled -agonist. Daily administration of montelukast sodium for the chronic treatment of asthma has not been established to prevent acute episodes of EIB.
  • Patients should be advised that, while using montelukast sodium, medical attention should be sought if short-acting inhaled bronchodilators are needed more often than usual, or if more than the maximum number of inhalations of short-acting bronchodilator treatment prescribed for a 24-hour period are needed.
  • Patients receiving montelukast sodium should be instructed not to decrease the dose or stop taking any other anti-asthma medications unless instructed by a physician.
  • Patients should be instructed to notify their physician if neuropsychiatric events occur while using montelukast sodium.
  • Patients with known aspirin sensitivity should be advised to continue avoidance of aspirin or non-steroidal anti-inflammatory agents while taking montelukast sodium.
  • Phenylketonuric patients should be informed that the 4-mg and 5-mg chewable tablets contain phenylalanine (a component of aspartame).

Marketed by:
Ajanta Pharma USA Inc.
Bridgewater, NJ 08807.

Made in India.

Revised: 09/2019

Patient Information

Montelukast Sodium (mon te loo' kast soe' dee um) Tablets, USP

Montelukast Sodium (mon te loo' kast soe' dee um) Chewable Tablets, USP

Montelukast Sodium (mon te loo' kast soe' dee um) Oral Granules, USP

Read the Patient Information Leaflet that comes with montelukast sodium before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What Is Montelukast Sodium? 

  • Montelukast sodium is a prescription medicine that blocks substances in the body called leukotrienes. This may help to improve symptoms of asthma and allergic rhinitis. Montelukast sodium does not contain a steroid.

Montelukast Sodium Is Used To: 

  1. Prevent asthma attacks and for the long-term treatment of asthma in adults and children ages 12 months and older.
    Do not take montelukast sodium if you need relief right away for a sudden asthma attack.If you get an asthma attack, you should follow the instructions your healthcare provider gave you for treating asthma attacks.
  2. Prevent exercise-induced asthma in people 6 years of age and older.
  3. Help control the symptoms of allergic rhinitis (sneezing, stuffy nose, runny nose, itching of the nose). Montelukast sodium tablets, chewable tablets or oral granules are used to treat:
    • outdoor allergies that happen part of the year (seasonal allergic rhinitis) in adults and children ages 2 years and older,and
    • indoor allergies that happen all year (perennial allergic rhinitis) in adults and children ages 6 months and older.

Who Should Not Take Montelukast Sodium? 

Do not take montelukast sodium if you are allergic to any of its ingredients.

Before Taking Montelukast Sodium, Tell Your Healthcare Provider If You: 

  • are allergic to aspirin
  • have phenylketonuria. Montelukast sodium chewable tablets contain aspartame, a source of phenylalanine
  • have any other medical conditions
  • are pregnant or plan to become pregnant. Talk to your doctor if you are pregnant or plan to become pregnant, as montelukast sodium may not be right for you.
  • are breast-feeding or plan to breast-feed. It is not known if montelukast sodium passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking montelukast sodium.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicines may affect how montelukast sodium works, or montelukast sodium may affect how your other medicines work.

For Anyone Who Takes Montelukast Sodium: 

  • Take montelukast sodium exactly as prescribed by your healthcare provider. Your healthcare provider will tell you how much montelukast sodium to take, andwhen to take it.
  • Do not stop taking montelukast sodium or change when you take it without talking with your healthcare provider.
  • You can take montelukast sodium with food or without food.

    Give montelukast sodium oral granules to your child exactly as instructed by your healthcare provider.

    Do not open the sachet until ready to use.

Montelukast Sodium 4-mg Oral Granules Can Be Given: 

  • right in the mouth; or
  • dissolved in 1 teaspoonful (5 mL) of cold or room temperature baby formula or breast milk; or
  • mixed with 1 spoonful of one of the following soft foods at cold or room temperature: applesauce, mashed carrots, rice, or ice cream.

Give the child all of the mixture right away, within 15 minutes.

Do not store any leftover montelukast sodium mixture (oral granules mixed with food, baby formula, or breast milk) for use at a later time.Throw away any unused portion.

Do not mix montelukast sodium oral granules with any liquid drink other than baby formula or breast milk.Your child may drink other liquids after swallowing the mixture.

The Dose Of Montelukast Sodium Prescribed For You Or Your Childs Condition Is Based On Age: 

  • 6 to 23 months: one sachet of 4-mg oral granules.
  • 2 to 5 years: one 4-mg chewable tablet or one sachet of 4-mg oral granules.
  • 6 to 14 years: one 5-mg chewable tablet.
  • 15 years and older: one 10-mg tablet.

What Should I Avoid While Taking Montelukast Sodium? 

If you have asthma and aspirin makes your asthma symptoms worse, continue to avoid taking aspirin or other medicines called non-steroidal anti-inflammatory drugs (NSAIDs) while taking montelukast sodium.

What Are The Possible Side Effects Of Montelukast Sodium? 

Montelukast sodium may cause serious side effects.

  • Behavior and mood-related changes.Tell your healthcare provider right away if you or your child have any of these symptoms while taking montelukast sodium:
    agitation including aggressive behavior or hostility
    attention problems
    bad or vivid dreams
    depression
    disorientation (confusion)
    feeling anxious
    hallucinations (

    • Montelukast sodium tablets, chewable tablets and granules come in a child-resistant package.
    • Store montelukast sodium at 59 F to 86 F (15 C to 30 C).
    • Keep montelukast sodium in the container it comes in.
    • Keep montelukast sodium in a dry place and away from light.

    General Information about the safe and effective use of montelukast sodium

    Medicines are sometimes prescribed for purposes other than those mentioned in Patient Information Leaflets. Do not use montelukast sodium tablets, chewable tablets or oral granules for a condition for which it was not prescribed. Do not give montelukast sodium tablets, chewable tablets or oral granules to other people even if they have the same symptoms you have. It may harm them.Keep montelukast sodium and all medicines out of the reach of children.

    This leaflet summarizes information about montelukast sodium. If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about montelukast sodium that is written for health professionals.

Active Ingredient: 

montelukast sodium

Inactive Ingredients: 

  • 4-mg oral granules: mannitol, hydroxypropyl cellulose, and magnesium stearate.
  • 4-mg and 5-mg chewable tablets: mannitol, microcrystalline cellulose, hydroxypropyl cellulose, ferric oxide red, croscarmellose sodium, cherry flavor, aspartame, and magnesium stearate.
    People with Phenylketonuria: Montelukast sodium 4-mg chewable tablets contain 0.449 mg of phenylalanine, and montelukast sodium 5-mg chewable tablets contain 0.561 mg of phenylalanine.
  • 10-mg tablet: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, hydroxypropyl cellulose, and magnesium stearate. The film coating contains: hydroxypropyl methylcellulose, hydroxypropyl cellulose, titanium dioxide, ferric oxide red, and ferric oxide yellow.

Marketed by:
Ajanta Pharma USA Inc.
Bridgewater, NJ 08807.

Made in India.

Revised: 09/2019



Your use of this website constitutes your agreement to the terms and conditions linked below:
Terms and Conditions | Resources | Sitemap
2017 © Copyright PharmacyHQ.com. Questions?
Please contact: phq.contact@gmail.com