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Onbrez Breezhaler

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How does Onbrez Breezhaler work? What will it do for me?

Indacaterol belongs to the class of medications called long-acting beta agonist bronchodilators. It is used to treat chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. It works by relaxing the muscles in the walls of the small air passages in the lungs. This helps open up the airways, making breathing easier, preventing symptoms such as wheezing and shortness of breath. Indacaterol can start to work within 5 minutes of inhalation, and its effects can last up to 24 hours.

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 using this medication, speak to your doctor. Do not stop using 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 Onbrez Breezhaler come in?

Each clear, colourless, hard gelatin capsule for inhalation contains indacaterol maleate equivalent to 75 µg of indacaterol. It has a black product code "IDL 75" printed on one side of the capsule and a symbol on the other side. This medication comes with an inhalation device. Non-medicinal ingredients: lactose monohydrate; shell: gelatine.

How should I use Onbrez Breezhaler?

The recommended adult dose of indacaterol is the contents of 1 capsule (75 µg) inhaled through the mouth with the provided inhalation device once a day at the same time every day. Continue using this medication even when you have no breathing problems or other symptoms of COPD. Only use this medication with the inhalation device contained within the same pack. Do not swallow the indacaterol capsules. Ask your pharmacist to demonstrate how to use the inhalation device.

This medication may be inhaled on an empty stomach or after food or drink.

This medication must not be used as a rescue medication to treat sudden, severe symptoms of COPD. Consult your doctor or pharmacist for advice about rescue medications that are appropriate for you. 

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 using the medication without consulting your doctor.

It is important to use this medication exactly as prescribed by your doctor.  If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not inhale 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.

Store this medication at room temperature, protect the capsules from light and moisture, and keep it out of 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 Onbrez Breezhaler?

Do not use indacaterol if you:

  • are allergic to indacaterol or any ingredients of the medication
  • have asthma
  • are experiencing sudden, severe symptoms of COPD
  • are under the age of 18

What side effects are possible with Onbrez Breezhaler?

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.

  • cough
  • headache
  • irritation or pain of the mouth or throat
  • muscle cramps
  • nausea
  • upper respiratory tract infection (e.g., runny nose, sore throat)

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:

  • COPD symptoms (breathlessness, wheezing, cough) do not improve or if they worsen during treatment
  • rapid or pounding heartbeat

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • bronchospasm with wheezing or coughing and difficulty breathing
  • breathing problems worsen quickly
  • symptoms of low potassium levels (e.g., muscle weakness, muscle spasms, or an abnormal heart rhythm)
  • symptoms of an allergic reaction (e.g., fainting from low blood pressure, rash or itching 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 Onbrez Breezhaler?

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: The safety and efficacy of this medication have not been established for people with asthma. Indacaterol belongs to the class of medication called long-acting beta-agonists (LABA). LABAs have been shown in a study to increase the risk of asthma-related deaths. Indacaterol should not be used to treat asthma.

Bronchospasm: Occasionally, inhaled medications may cause the airways to spasm and close up (bronchospasm), which makes breathing even more difficult and can be life-threatening. If you experience increased difficulty breathing after using a dose of indacaterol, seek immediate medical attention.

Diabetes: Indacaterol may cause a loss of blood glucose control 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.

Heart problems: This medication can cause increased heart rate and blood pressure, as well as rapid or irregular heart beat or abnormal electrical signal called “prolonged QT interval". These effects may worsen symptoms of heart disease. If you have heart disease such as angina, congestive heart failure, or arrhythmia, 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. Contact your doctor as soon as possible if you develop symptoms of heart problems such as shortness of breath, chest pain, rapid heartbeat, or swollen ankles.

Low potassium levels: Indacaterol may cause decreased levels of potassium in the blood. This can cause abnormal heart rhythms, weakness, fatigue, muscle cramps or constipation. If you experience any of these symptoms, contact your doctor.

Lactose allergy: This medication contains lactose (milk sugar) and a small amount of milk proteins. It is possible that people who have a severe milk protein allergy may have an allergic reaction to this medication. Speak to your doctor if you have any concerns.

Seizures: If you have a history of epilepsy or medical conditions that increase the risk of seizures, 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.

Sudden symptoms of COPD: Indacaterol is not a "reliever" or "rescue" medication. If you start developing acute symptoms such as breathlessness, wheezing, and cough, you should use your "reliever" medication for rapid relief of your symptoms. It is very important that you have your "reliever" medication with you at all times. Seek emergency medical help if your breathing problems worsen quickly or if you use your rescue medication but it does not relieve your breathing problems.

Thyroid gland problems: If you have thyroid disease, 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.

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 indacaterol passes into breast milk. If you are a breast-feeding mother 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 people age 18 and under.

What other drugs could interact with Onbrez Breezhaler?

There may be an interaction between indacaterol and any of the following:

  • alfuzosin
  • amantadine
  • amiodarone
  • amphetamines (e.g., dextroamphetamine, lisdexamfetamine)
  • anagrelide
  • antihistamines (e.g,. cetirizine, doxylamine, diphenhydramine, hydroxyzine, loratadine)
  • antipsychotics (e.g., chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone)
  • apomorphine
  • atomoxetine
  • “azole” antifungals (e.g., itraconazole, ketoconazole, voriconazole)
  • beta-blockers (e.g., metoprolol, propranolol, timolol)
  • betahistine
  • beta 2 agonists (e.g., salbutamol, formoterol, terbutaline)
  • caffeine
  • chloral hydrate
  • chloroquine
  • cisapride
  • oral corticosteroid medications (e.g., dexamethasone, hydrocortisone, prednisone)
  • decongestant cold medications (e.g., phenylephrine, pseudoephedrine)
  • decongestant eye drops and nose sprays (e.g., naphazoline, oxymetazoline, xylometazoline)
  • dipivefrin
  • disopyramide
  • domperidone
  • dopamine
  • dronedarone
  • epinephrine
  • famotidine
  • fingolimod
  • flecainide
  • formoterol
  • galantamine
  • linezolid
  • lithium
  • loop diuretics (water pills; bumetanide, furosemide)
  • lopinavir
  • loxapine
  • macrolide antibiotics (e.g., clarithromycin, erythromycin)
  • maprotiline
  • mefloquine
  • methadone
  • methylphenidate
  • metoclopramide
  • metronidazole
  • mirabegron
  • monoamine oxidase inhibitors (MAOIs; e.g., moclobemide, phenelzine, rasagiline, selegiline, tranylcypromine)
  • norepinephrine
  • octreotide
  • paliperidone
  • pentamidine
  • pimozide
  • primaquine
  • procainamide
  • propafenone
  • romidepsin
  • quinidine
  • quinine
  • quinolone antibiotics (e.g., ciprofloxacin, norfloxacin, ofloxacin)
  • ritonavir
  • saquinavir
  • selective serotonin reuptake inhibitors (ssris; e.g., citalopram, duloxetine, fluoxetine, paroxetine, sertraline)
  • serotonin antagonists (anti-emetic medications; e.g., granisetron, ondansetron)
  • sulfamethoxazole
  • tacrolimus
  • tamoxifen
  • tetrabenazine
  • theophyllines (e.g., aminophylline, oxtriphylline, theophylline)
  • thiazide diuretics (water pills; e.g., hydrochlorothiazide, indapamide, metolazone)
  • trazodone
  • tricyclic antidepressants (e.g., amitriptyline, clomipramine, desipramine, trimipramine) trimethoprim
  • tyrosine kinase inhibitors (e.g., dasatinib, imatinib, nilotinib)
  • venlafaxine

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.

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