How does this medication work? What will it do for me?

This combination product contains three medications: glycopyrronium, indacaterol, and mometasone. Glycopyrronium belongs to the group of medications called long-acting muscarinic antagonists (LAMA). Indacaterol belongs to the group of medications called long-acting bronchodilators. These medications work in different ways to relax the muscles in the walls of the small air passages in the lungs, keeping the air passages open and making it easier to breathe. Mometasone belongs to the group of medications called corticosteroids. It helps to control difficulty breathing by reducing the swelling in the airways of the lungs.

This medication is used to prevent and control asthma symptoms for adults who are using an inhaled long-acting bronchodilator and a corticosteroid and are still experiencing asthma flare-ups. When used regularly, glycopyrronium – indacaterol - mometasone will help prevent and control asthma symptoms. It will not relieve an asthma attack once it has already started. Regular daily use is important for this medication to be effective. It will not relieve an episode of increased difficulty breathing.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

Each hard capsule filled with powder for inhalation contains 150 mg of indacaterol (as acetate), 50 mg of glycopyrronium (as bromide), and 160 mg mometasone furoate. Nonmedicinal ingredients: carrageenan, hypromellose, lactose (as monohydrate), magnesium stearate, potassium chloride, and purified water.

How should I use this medication?

Glycopyrronium - indacaterol – mometasone is inhaled into the lungs through the mouth. Do not swallow this medication.

The recommended adult dose of glycopyrronium - indacaterol – mometasone is to inhale the contents of one capsule once daily, using the Breezhaler™ inhaler device that comes in the package with the medication. Your health care professional should show you how to use the device. If you are not sure about how to use the device, contact your doctor or pharmacist for advice.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor. It is important to take this medication exactly as prescribed by your doctor. If you miss a dose of this medication, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

This medication will not relieve an episode of troubled breathing. If you experience shortness of breath, use your short-acting bronchodilator. If you find you need to use your short-acting ("rescue") inhaler more often or if your condition seems to worsen, call your doctor.

Store this medication at room temperature, in its original package. Remove capsules from the package when you are ready to inhale a dose. Protect it from light and moisture, and keep it out of the reach of children. 

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not take this medication if you are allergic to glycopyrronium, indacaterol, or mometasone, or any ingredients of the medication.

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • abdominal cramps
  • cough
  • diarrhea
  • dry mouth
  • headache
  • itchy skin
  • mouth and throat pain or irritation
  • muscle, bone, or joint pain
  • muscle spasm
  • nausea
  • rash
  • voice changes, hoarseness
  • vomiting

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • fast, pounding, or irregular heartbeat
  • pain or difficulty passing urine
  • symptoms of cataracts (e.g., clouding of the lens of the eye, blurred vision, dim vision, eye pain)
  • symptoms of glaucoma (e.g., blurred vision, seeing halos of bright colours around lights, red eyes, increased pressure in your eyes, eye pain or discomfort)
  • symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)
  • symptoms of thrush (yeast infection in the mouth and throat; white patches in the mouth, sore throat)
  • symptoms of a urinary tract infection (e.g., pain when urinating, urinating more often than usual, low back or flank pain)
  • vision changes (e.g., distorted or blurred vision)

if any of the following occur:

  • chest tightness and coughing immediately after using the inhaler
  • signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Asthma control: This medication is not for use as a "reliever" medication. If you start to have an asthma attack, be sure to use your "reliever" medication for rapid relief of your asthma symptoms. Contact your doctor immediately if you find you are using your "reliever" medications (e.g., salbutamol, terbutaline, formoterol) more often or if they are not working as well as they used to. This may mean your asthma is not controlled. Your doctor may want you to temporarily change the dose of this medication or may start you on an oral corticosteroid.

Diabetes: This medication may cause an increase in blood sugar levels and glucose tolerance may change. People with diabetes may find it necessary to monitor their blood sugar more frequently while using this medication.

If you have diabetes or are at risk for developing diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Eye problems: Glycopyrronium may cause symptoms of glaucoma (increased pressure in the eye) to worsen. If you have glaucoma, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. If you experience eye pain or discomfort, blurred vision, or visual halos, contact your doctor immediately.

Long-term use of mometasone or other inhaled corticosteroids may also cause damage to the optic nerves or it may produce cataracts. It may also increase the risk of eye infections due to fungi or viruses. You should discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Heart conditions: This medication can cause an increase in blood pressure or heart rate in addition to changes to the heart rhythm. If you have any heart conditions, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Heart rhythm: Glycopyrronium - indacaterol – mometasone can cause changes to the normal rate and rhythm of the heart, as well as increased blood pressure. Overuse of this medication can cause life-threatening conditions, including rapid heartbeat, angina, or heart attack. If you are at risk for heart rhythm problems (e.g., people with heart failure, angina, low potassium or magnesium levels), or are taking other medications that can cause heart rhythm problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Infections: This medication, like other medications that contain corticosteroids, may prevent the early signs of a serious infection from being noticed. Try to limit the amount of time you spend around others who have recently had infections such as chickenpox or measles. If you do come into contact with someone who has one of these infections, contact your doctor for advice. If you have a history of tuberculosis; shingles affecting your eye(s); or fungal, bacterial, viral, or parasitic infections, talk to your doctor before starting this medication.

Inhalation-induced bronchospasm: Inhaled forms of medications may cause spasms of the airways which make breathing difficult. If you experience this problem when using glycopyrronium – indacaterol – mometasone, stop using this medication immediately. Speak to your doctor if you experience any problems with breathing while taking this or other inhaled medication.

Lactose: This medication contains lactose. If you have hereditary problems of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption, talk to your doctor about whether this medication is appropriate for you.

Oral hygiene: Adequate oral hygiene, such as rinsing your mouth with water after using this medication, helps reduce the chances of developing thrush, a yeast (fungal) infection of the mouth or throat. If you develop symptoms of thrush, such as white patches in your mouth, contact your doctor.

Osteoporosis: Over time, mometasone can increase the risk of osteoporosis (brittle bones), just like other corticosteroids. Talk to your doctor about ways to help prevent osteoporosis. Your doctor will monitor your bone density if you need to take this medication for a long period of time.

Steroid medication use: If you have taken or are still taking an oral steroid medication (e.g., prednisone) during the last several months, consult your doctor before using this medication. In times of stress or during a severe asthma attack, your doctor may want you to start your steroid medication again.

Stopping medication: Do not stop this medication abruptly. When this medication is stopped, it should be stopped gradually, as directed by your doctor.

Urinary tract problems: This medication can cause increased difficulty with urine flow and urinary retention. If you have an enlarged prostate gland or other condition that makes it difficult to pass urine, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you experience difficulty starting to urinate or have pain when you urinate, speak with your doctor as soon as possible.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if glycopyrronium – indacaterol - mometasone passes into breast milk. If you are breast-feeding and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children. 

What other drugs could interact with this medication?

There may be an interaction between glycopyrronium – indacaterol - mometasone and any of the following:

  • aclidinium
  • aldesleukin
  • antiarrhythmics (e.g., amiodarone, disopyramide, dronedarone, procainamide, quinidine)
  • antihistamines (e.g., bilastine, cetirizine, doxylamine, diphenhydramine, hydroxyzine, loratadine, rupatadine)
  • antipsychotics (e.g., chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone)
  • amantadine
  • amphetamines (e.g., dextroamphetamine, lisdexamfetamine)
  • atomoxetine
  • atropine
  • azelastine
  • azole antifungals (e.g., itraconazole, ketoconazole)
  • belladonna
  • benztropine
  • beta-adrenergic blockers (e.g., atenolol, propranolol, sotalol)
  • other beta-2 agonists (e.g., formoterol, olodaterol, salbutamol, salmeterol, vilanterol)
  • betahistine
  • botulinum toxin-containing products
  • caffeine
  • cannabis
  • clidinium
  • cobicistat
  • cyclobenzaprine
  • darifenacin
  • decongestant cold medications (e.g., phenylephrine, pseudoephedrine)
  • decongestant eye drops and nose sprays (e.g., naphazoline, oxymetazoline, xylometazoline)
  • desmopressin
  • dexmethylphenidate
  • diuretics (water pills; e.g., furosemide, hydrochlorothiazide, triamterene)
  • domperidone
  • donepezil
  • eluxadoline
  • epinephrine
  • fesoterodine
  • flavoxate
  • galantamine
  • glucagon
  • ipratropium
  • ketotifen
  • linezolid
  • methadone
  • methylphenidate
  • metoclopramide
  • mirabegron
  • monoamine oxidase inhibitors (MAOIs; e.g., moclobemide, phenelzine, tranylcypromine)
  • modafinil
  • narcotic pain relievers (e.g., codeine, fentanyl, hydromorphone, morphine)
  • nelfinavir
  • nitroglycerin
  • orphenadrine
  • oxybutynin
  • potassium supplements
  • propantheline
  • quinine
  • ritonavir
  • rivastigmine
  • scopolamine
  • solifenacin
  • theophyllines (e.g., aminophylline, oxtriphylline, theophylline)
  • tiotropium
  • tolterodine
  • topiramate
  • tricyclic antidepressants (e.g., amitriptyline, clomipramine, desipramine, trimipramine)
  • umeclidinium

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2021. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Enerzair-Breezhaler