SINGULAIR montelukast sodium

Get an overview of SINGULAIR (montelukast sodium tablet, chewable), 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, CHEWABLE

Data Current As Of: 2019-03-18

indications & usage

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.

drug interactions

No dose adjustment is needed when SINGULAIR is co-administered with theophylline, prednisone, prednisolone, oral contraceptives, terfenadine, 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

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

Information for Patients

  • Patients should be advised 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.
  • Patients should be advised 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.
  • Patients should be advised that, while using SINGULAIR, 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 SINGULAIR 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 SINGULAIR.
  • Patients with known aspirin sensitivity should be advised to continue avoidance of aspirin or non-steroidal anti-inflammatory agents while taking SINGULAIR.
  • Phenylketonuric patients should be informed that the 4-mg and 5-mg chewable tablets contain phenylalanine (a component of aspartame).

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 © 1998-2019 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved.

uspi-mk0476-mf-1902r039

Patient Information
SINGULAIR® (SING-u-lair)
(montelukast sodium)
Tablets

SINGULAIR®
(montelukast sodium)
Chewable Tablets

SINGULAIR®
(montelukast sodium)
Oral Granules

Read the Patient Information Leaflet that comes with SINGULAIR® 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 SINGULAIR?

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

SINGULAIR 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 SINGULAIR 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). SINGULAIR is 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 SINGULAIR?

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

See the end of this leaflet for a complete list of the ingredients in SINGULAIR.

What should I tell my healthcare provider before taking SINGULAIR?

Before taking SINGULAIR, tell your healthcare provider if you:

  • are allergic to aspirin
  • have phenylketonuria. SINGULAIR 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 SINGULAIR may not be right for you.
  • are breast-feeding or plan to breast-feed. 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 non-prescription 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:

  • 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.
  • Do not stop taking SINGULAIR or change when you take it without talking with your healthcare provider.
  • You can take SINGULAIR with food or without food. See the information below in the section "How should I give SINGULAIR oral granules to my child?" 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 or a Poison Control Center 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.
  • Do not take SINGULAIR if you need relief right away from a sudden asthma attack. If you get an asthma attack, you should follow the instructions your healthcare provider gave you for treating asthma attacks.
  • Always have your rescue inhaler medicine with you for asthma attacks.
  • Do not stop taking or lower the dose of your other asthma medicines unless your healthcare provider tells you to.

For patients 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 adults and children 2 years of age and older with seasonal allergic rhinitis, or for adults and children 6 months of age and older with perennial allergic rhinitis:

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

How should I give SINGULAIR oral granules to my child?

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

Do not open the packet until ready to use.

SINGULAIR 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 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.

What is the dose of SINGULAIR?

The dose of SINGULAIR prescribed for your or your child's condition is based on age:

  • 6 to 23 months: one packet of 4-mg oral granules.
  • 2 to 5 years: one 4-mg chewable tablet or one packet 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 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.

  • Behavior and mood-related changes. Tell your healthcare provider right away if you or your child have any of these symptoms while taking SINGULAIR:
  • agitation including aggressive behavior or hostility
  • attention problems
  • bad or vivid dreams
  • depression
  • disorientation (confusion)
  • feeling anxious
  • hallucinations (seeing or hearing things that are not really there)
  • irritability
  • memory problems
  • obsessive-compulsive symptoms
  • restlessness
  • sleep walking
  • stuttering
  • suicidal thoughts and actions (including suicide)
  • tremor
  • trouble sleeping
  • uncontrolled muscle movements
  • 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
    • rash
    • severe inflammation (pain and swelling) of the sinuses (sinusitis)

The most common side effects with SINGULAIR include:

Other side effects with SINGULAIR include:

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of SINGULAIR. For more information ask your healthcare provider or pharmacist.

Call your healthcare provider 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 59°F to 86°F (15°C to 30°C).
  • Keep SINGULAIR in the container it comes in.
  • Keep SINGULAIR in a dry place and away from light.

General Information about the safe and effective use of SINGULAIR

Medicines are sometimes prescribed for purposes other than those mentioned in Patient Information Leaflets. 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. Keep SINGULAIR and all medicines out of the reach of children.

This leaflet summarizes information about SINGULAIR. If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about SINGULAIR that is written for health professionals. For more information, call the Merck National Service Center at 1-800-NSC-Merck (1-800-672-6372).

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 © 1998-2019 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved.

Revised: 02/2019

usppi-mk0476-mf-1902r035

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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