SINGULAIR montelukast sodium

Get an overview of SINGULAIR (montelukast sodium tablet, film coated), including its generic name, formulation (i.e. pill, oral solution, injection, inhaled medicine) and why it’s used. The medication in SINGULAIR can be sold under different names.

Refer to the “Also Known As” section to reference different products that include the same medication as SINGULAIR.

Drug Basics

Brand Name: SINGULAIR

Generic Name: MONTELUKAST SODIUM

Drug Type: HUMAN PRESCRIPTION DRUG

Route: ORAL

Dosage Form: TABLET, FILM COATED

Packager: Merck Sharp & Dohme Corp.

Data Current As Of: 2021-03-15

Boxed Warning 04/2020
Indications and Usage (1.3, 1.4) 02/2021
Dosage and Administration (2.1, 2.2, 2.3, 2.4) 02/2021
Warnings and Precautions (5.1, 5.6) 02/2021

Indications & Usage

SINGULAIR is a leukotriene receptor antagonist indicated for:

  • Prophylaxis and chronic treatment of asthma in patients 12 months of age and older (1.1).
  • Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older (1.2).
  • Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 2 years of age and older, and perennial allergic rhinitis (PAR) in patients 6 months of age and older. Reserve use for patients who have an inadequate response or intolerance to alternative therapies (1.3).

Limitations of Use:

  • Not indicated to treat an acute asthma attack (5.2).

asthma

SINGULAIR® is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older.

exercise-induced bronchoconstriction (eib)

SINGULAIR is indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older.

allergic rhinitis

SINGULAIR is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 6 months of age and older. Because the benefits of SINGULAIR may not outweigh the risk of neuropsychiatric symptoms in patients with allergic rhinitis [see Warnings and Precautions (5.1)], reserve use for patients who have an inadequate response or intolerance to alternative therapies.

limitations of use

SINGULAIR is not indicated for the treatment of an acute asthma attack.

Drug Interactions

No dose adjustment is needed when SINGULAIR is co-administered with theophylline, prednisone, prednisolone, oral contraceptives, fexofenadine, digoxin, warfarin, gemfibrozil, itraconazole, thyroid hormones, sedative hypnotics, non-steroidal anti-inflammatory agents, benzodiazepines, decongestants, and Cytochrome P450 (CYP) enzyme inducers [see Clinical Pharmacology (12.3)].

Patient Counseling Information

For the tablets and chewable tablets, advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide).

For the oral granules, advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).

  • Advise patients about the potential risk for serious neuropsychiatric symptoms and behavioral changes with SINGULAIR use [see Warnings and Precautions (5.1)].
  • Discuss the benefits and risks of SINGULAIR with patients when prescribing or continuing treatment with SINGULAIR [see Warnings and Precautions (5.1)].
  • Advise patients to monitor for changes in behavior or neuropsychiatric symptoms in patients taking SINGULAIR [see Warnings and Precautions (5.1)].
  • Instruct patients to discontinue SINGULAIR and contact a healthcare provider immediately if changes in behavior or thinking that are not typical for the patient occur, or if the patient develops suicidal ideation or suicidal behavior [see Warnings and Precautions (5.1)].
  • Advise patients to take SINGULAIR 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.
  • Advise patients that oral SINGULAIR is not for the treatment of acute asthma attacks. They should have appropriate short-acting inhaled β-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 β-agonist. Daily administration of SINGULAIR for the chronic treatment of asthma has not been established to prevent acute episodes of EIB [see Warnings and Precautions (5.2)].
  • Advise patients to seek medical attention 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.
  • Instruct patients to continue other anti-asthma medications as prescribed unless instructed by a physician.
  • Instruct patients with known aspirin sensitivity to continue avoidance of aspirin or non-steroidal anti-inflammatory agents while taking SINGULAIR [see Warnings and Precautions (5.4)].
  • Inform phenylketonuric patients that the 4-mg and 5-mg chewable tablets contain phenylalanine (a source of aspartame) [see Warnings and Precautions (5.6)].

Dist. by: Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

For patent information: www.merck.com/product/patent/home.html

Copyright © 1998-2021 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved.

uspi-mk0476-mf-2102r042

MEDICATION GUIDE
SINGULAIR® (SING-u-lair)
(montelukast sodium)
                      tablets chewable tablets oral granules
This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: 04/2020

What is the most important information I should know about SINGULAIR?

Serious mental health problems have happened in people taking SINGULAIR or even after treatment has stopped. This can happen in people with or without a history of mental health problems. Stop taking SINGULAIR 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:

  • 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 is SINGULAIR?

SINGULAIR is 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). SINGULAIR does not contain a steroid. SINGULAIR is used to:

  • Prevent asthma attacks and for the long-term treatment of asthma in adults and children ages 12 months and older. Do not take SINGULAIR 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.
  • Prevent exercise-induced asthma in people 6 years of age and older.
  • Help control the symptoms of allergic rhinitis such as sneezing, stuffy nose, runny nose, and itching of the nose. SINGULAIR is 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 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.

Do not take SINGULAIR if you are allergic to any of its ingredients. See the end of this Medication Guide for a complete list of the ingredients in SINGULAIR.

Before taking SINGULAIR, tell your healthcare provider about all your medical conditions, including if you:

  • are allergic to aspirin.
  • have phenylketonuria. SINGULAIR chewable tablets contain aspartame, a source of phenylalanine.
  • 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, SINGULAIR may not be right for you.
  • are breastfeeding or plan to breastfeed. It is not known if SINGULAIR passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking SINGULAIR.

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 SINGULAIR works, or SINGULAIR may affect how your other medicines work.

How should I take SINGULAIR?

For anyone who takes SINGULAIR:

  • Read the detailed Instructions for Use that comes with SINGULAIR oral granules.
  • Take SINGULAIR exactly as prescribed by your healthcare provider. Your healthcare provider will tell you how much SINGULAIR to take, and when to take it.
  • Stop taking SINGULAIR and tell your healthcare provider right away if you or your child have any unusual changes in behavior or thinking.
  • You can take SINGULAIR with food or without food. See the section "How can I give SINGULAIR oral granules to my child?" in the Instructions for Use for information about what foods and liquids can be taken with SINGULAIR oral granules.
  • If you or your child misses a dose of SINGULAIR, just take the next dose at your regular time. Do not take 2 doses at the same time.
  • If you take too much SINGULAIR, call your healthcare provider right away.

For adults and children 12 months of age and older with asthma:

  • Take SINGULAIR 1 time each day, in the evening. Continue to take SINGULAIR 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 people 6 years of age and older for the prevention of exercise-induced asthma:

  • Take SINGULAIR at least 2 hours before exercise.
  • Always have your rescue inhaler medicine with you for asthma attacks.
  • If you take SINGULAIR every day for chronic asthma or allergic rhinitis, do not take another dose to prevent exercise-induced asthma. Talk to your healthcare provider about your treatment for exercise-induced asthma.
  • Do not take 2 doses of SINGULAIR within 24 hours (1 day).

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 SINGULAIR 1 time each day, at about the same time each day.

What should I avoid while taking SINGULAIR?

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 SINGULAIR.

What are the possible side effects of SINGULAIR?

SINGULAIR may cause serious side effects, including:

  • See “What is the most important information I should know about SINGULAIR?”
  • 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 SINGULAIR. 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

The most common side effects of SINGULAIR include:

These are not all the possible side effects of SINGULAIR. 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 SINGULAIR?

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

General information about the safe and effective use of SINGULAIR.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use SINGULAIR for a condition for which it was not prescribed. Do not give SINGULAIR 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 SINGULAIR that is written for health professionals.

What are the ingredients in SINGULAIR?

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, red ferric oxide, croscarmellose sodium, cherry flavor, aspartame, and magnesium stearate.
  • People with Phenylketonuria: SINGULAIR 4-mg chewable tablets contain 0.674 mg of phenylalanine and SINGULAIR 5-mg chewable tablets contain 0.842 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, red ferric oxide, yellow ferric oxide, and carnauba wax.

Dist. by: Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

For patent information: www.merck.com/product/patent/home.html

Copyright © 1998-2020 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved.

usmg-mk0476-mf-2004r001

Instructions For Use

SINGULAIR® (SING-u-lair)
(montelukast sodium)
oral granules

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

Important Information:

  • Before giving a dose of SINGULAIR oral granules, read this Instructions for Use to be sure you prepare and give the oral granules correctly.
  • Give SINGULAIR oral granules to your child exactly as instructed by your healthcare provider.
  • Stop giving SINGULAIR 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 SINGULAIR oral granules with food or without food.

How can I give SINGULAIR oral granules to my child?

  • Do not open the packet until ready to use.
  • There are different ways you can give SINGULAIR 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 SINGULAIR 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 SINGULAIR 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 SINGULAIR?

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

Dist. by: Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

For patent information: www.merck.com/product/patent/home.html
Copyright © 1998-2020 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved.
usifu-mk0476-og-2004r001
For more information, call the Merck National Service Center at 1-800-NSC-Merck (1-800-672-6372)

This Instructions for Use has been approved by the U.S. Food and Drug Administration                                                Approved: April 2020

also known as

This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. If you think you may have a medical emergency, immediately call your doctor or dial 911. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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