MONTELUKAST SODIUM - montelukast sodium granule 
Aurobindo Pharma Limited

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MEDICATION GUIDE
Montelukast Sodium Oral Granules, USP
(mon te loo' kast soe' dee um)
What is the most important information I should know about montelukast sodium oral granules?
Serious mental health problems have happened in people taking montelukast sodium oral granules or even after treatment has stopped. This can happen in people with or without a history of mental health problems. Stop taking montelukast sodium oral granules and tell your healthcare provider right away if you or your child have any unusual changes in behavior or thinking, including any of these symptoms:
 
  • agitation, including aggressive behavior or hostility
  • attention problems
  • bad or vivid dreams
  • depression
  • disorientation (confusion)
  • feeling anxious
  • irritability
  • hallucinations (seeing or hearing things that are not really there)
  • memory problems
  • obsessive-compulsive symptoms
  • restlessness
  • sleep walking
  • stuttering
  • suicidal thoughts and actions (including suicide)
  • tremor
  • trouble sleeping
  • uncontrolled muscle movements
What are montelukast sodium oral granules?
 
Montelukast sodium oral granules are a prescription medicine that blocks substances in the body called leukotrienes. This may help to improve symptoms of asthma and inflammation of the lining of the nose (allergic rhinitis). Montelukast sodium oral granules does not contain a steroid.
 
Montelukast sodium oral granules are used to:
 
1. Prevent asthma attacks and for the long-term treatment of asthma in children ages 12 months and older.
 
 Do not take montelukast sodium oral granules if you need relief right away for a sudden asthma attack. If you have an asthma attack, you should follow the instructions your healthcare provider gave you for treating asthma attacks.
 
3. Help control the symptoms of allergic rhinitis such as sneezing, stuffy nose, runny nose, and itching of the nose. Montelukast sodium oral granules are used to treat the following in people who have already taken other medicines that did not work well enough or in people who could not tolerate other medicines:
 
  • outdoor allergies that happen part of the year (seasonal allergic rhinitis) in children ages 2 years and older, and
  • indoor allergies that happen all year (perennial allergic rhinitis) in children ages 6 months and older.
Do not take montelukast sodium oral granules if you are allergic to any of its ingredients. See the end of this Medication Guide for a complete list of the ingredients in montelukast sodium oral granules.
Before taking montelukast sodium oral granules, tell your healthcare provider about all your medical conditions, including if you:
  • are allergic to aspirin.
  • have or have had mental health problems.
  • are pregnant or plan to become pregnant. Talk to your healthcare provider if you are pregnant or plan to become pregnant, montelukast sodium oral granules may not be right for you.
  • are breastfeeding or plan to breastfeed. 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 oral granules.
Tell your healthcare provider about all the medicines you take, including prescription and over the counter medicines, vitamins, and herbal supplements. Some medicines may affect how montelukast sodium oral granules work, or montelukast sodium oral granules may affect how your other medicines work.
How should I take montelukast sodium oral granules?
 
For anyone who takes montelukast sodium oral granules:
  • Read the detailed Instructions for Use that comes with montelukast sodium oral granules.
  • Take montelukast sodium oral granules exactly as prescribed by your healthcare provider. Your healthcare provider will tell you how much montelukast sodium oral granules to take, and when to take it.
  • Stop taking montelukast sodium oral granules and tell your healthcare provider right away if you or your child have any unusual changes in behavior or thinking.
  • You can take montelukast sodium oral granules with food or without food. See the section "How can I give montelukast sodium oral granules to my child?" in the Instructions for Use for information about what foods and liquids can be taken with montelukast sodium oral granules.
  • If you or your child misses a dose of montelukast sodium oral granules, just take the next dose at your regular time. Do not take 2 doses at the same time.
  • If you take too much montelukast sodium, call your healthcare provider right away. 
For adults and children 12 months of age and older with asthma:
  • Take montelukast sodium oral granules 1 time each day, in the evening. Continue to take montelukast sodium oral granules every day for as long as your healthcare provider prescribes it, even if you have no asthma symptoms.
  • Tell your healthcare provider right away if your asthma symptoms get worse, or if you need to use your rescue inhaler medicine more often for asthma attacks.
  • Always have your rescue inhaler medicine with you for asthma attacks.
  • Continue to take your other asthma medicines as prescribed unless your healthcare provider tells you to change how you take these medicines.
For anyone 2 years of age and older with seasonal allergic rhinitis, or for anyone 6 months of age and older with perennial allergic rhinitis:
  • Take montelukast sodium oral granules 1 time each day, at about the same time each day.
What should I avoid while taking montelukast sodium oral granules?
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 oral granules.
What are the possible side effects of montelukast sodium oral granules?
Montelukast sodium oral granules may cause serious side effects, including:
  • See “What is the most important information I should know about montelukast sodium oral granules?”
  • Increase in certain white blood cells (eosinophils) and possible inflamed blood vessels throughout the body (systemic vasculitis). Rarely, this can happen in people with asthma who take montelukast sodium oral granules. This sometimes happens in people who also take a steroid medicine by mouth that is being stopped or the dose is being lowered.
Tell your healthcare provider right away if you get one or more of these symptoms:
  • a feeling of pins and needles or numbness of arms or legs
  • a flu-like illness
  • rash
  • severe inflammation (pain and swelling) of the sinuses (sinusitis)
The most common side effects of montelukast sodium oral granules include:
  • upper respiratory infection
  • fever
  • headache
  • sore throat
  • cough
  • stomach pain
  • diarrhea
  • earache or ear infection
  • flu
  • runny nose
  • sinus infection
These are not all the possible side effects of montelukast sodium oral granules. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store montelukast sodium oral granules?
  • Store montelukast sodium oral granules at room temperature between 68°F to 77°F (20°C to 25°C).
  • Keep montelukast sodium oral granules in the package it comes in. 
  • Keep montelukast sodium oral granules in a dry place and keep it away from light.
  • Keep montelukast sodium oral granules and all medicines out of reach of children.
General information about the safe and effective use of montelukast sodium oral granules.  
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use montelukast sodium oral granules for a condition for which it was not prescribed. Do not give montelukast sodium oral granules to other people even if they have the same symptoms you have. It may harm them.
 
You can ask your pharmacist or healthcare provider for information about montelukast sodium oral granules that is written for health professionals.
What are the ingredients in montelukast sodium oral granules?
Active ingredient: montelukast sodium
 
Inactive ingredients: hydroxypropyl cellulose, magnesium stearate, and mannitol.
Dispense with Medication Guide available at: www.aurobindousa.com/medication-guides 
 
Distributed by:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520

Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 038, India
 
For more information, call Aurobindo Pharma USA, Inc. at 1-866-850-2876.

This Medication Guide has been approved by the U.S. Food and Drug Administration


Revised: 03/2021

INSTRUCTIONS FOR USE
Montelukast Sodium Oral Granules, USP

(mon te loo' kast soe' dee um)


This Instructions for Use contains information on how to use montelukast sodium oral granules.

Important Information:

  • Before giving a dose of montelukast sodium oral granules, read this Instructions for Use to be sure you prepare and give the oral granules correctly.
  • Give montelukast sodium oral granules to your child exactly as instructed by your healthcare provider.
  • Stop giving montelukast sodium oral granules and tell your healthcare provider right away if your child has any unusual changes in behavior or thinking.
  • Continue to give your child their asthma medicines as prescribed, unless your healthcare provider tells you to change how you give these medicines.
  • You can give montelukast sodium oral granules with food or without food.

How can I give montelukast sodium oral granules to my child?

  • Do not open the packet until ready to use.
  • There are different ways you can give montelukast 4 mg oral granules. You should choose the best method for your child:
    • right into the mouth
    • dissolved in 1 teaspoonful (5 mL) of cold or room temperature baby formula or breast milk
    • 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 within 15 minutes.
  • Do not store any leftover montelukast sodium oral granules 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.

How should I store montelukast sodium oral granules?

  • Store montelukast sodium oral granules at room temperature between 68°F to 77°F (20°C to 25°C).
  • Keep montelukast sodium oral granules in the package it comes in.
  • Keep montelukast sodium oral granules in a dry place and keep it away from light.
  • Keep montelukast sodium oral granules and all medicines out of the reach of children.

Distributed by:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520

Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 038, India

For more information, call Aurobindo Pharma USA, Inc. at 1-866-850-2876.


This Instructions for Use has been approved by the U.S. Food and Drug Administration


Revised: 03/2021

Revised: 6/2023
Document Id: 2fcb1880-c88e-4c82-829e-6177a07814c4
Set id: 9a3bfc59-0ca6-4433-abf5-41659bfe0a8f
Version: 8
Effective Time: 20230603
Aurobindo Pharma Limited