Bemrist Breezhaler (Indacaterol / Mometasone Furoate)
Combination inhaled corticosteroid and long-acting beta2-agonist for asthma maintenance therapy
Quick Facts About Bemrist Breezhaler
Key Takeaways About Bemrist Breezhaler
- Once-daily maintenance inhaler: Bemrist Breezhaler is taken once a day at the same time each day for ongoing asthma control, not for acute symptom relief
- Dual mechanism of action: Combines a bronchodilator (indacaterol) that opens the airways with an anti-inflammatory corticosteroid (mometasone) that reduces airway swelling
- Not a rescue inhaler: Always keep a separate short-acting bronchodilator (such as salbutamol) available for sudden asthma symptoms or attacks
- Rinse your mouth after use: Rinsing with water and spitting out after each dose helps prevent oral thrush (candidiasis), a common side effect of inhaled corticosteroids
- Never stop abruptly: Do not stop using Bemrist Breezhaler suddenly without consulting your doctor, as this may lead to worsening of asthma symptoms
What Is Bemrist Breezhaler and What Is It Used For?
Bemrist Breezhaler is a combination inhaler that contains two active ingredients: indacaterol acetate (a long-acting beta2-agonist) and mometasone furoate (an inhaled corticosteroid). It is prescribed as once-daily maintenance treatment for asthma in patients aged 12 years and older whose asthma is not adequately controlled with an inhaled corticosteroid alone.
Asthma is a chronic inflammatory disease of the airways characterised by variable airflow obstruction, bronchial hyperresponsiveness, and airway inflammation. According to the Global Initiative for Asthma (GINA), an estimated 262 million people worldwide were affected by asthma in 2019, and it remains one of the most common chronic respiratory diseases globally. Effective long-term management requires both bronchodilation and anti-inflammatory therapy in many patients.
Bemrist Breezhaler addresses both key aspects of asthma pathophysiology through its dual mechanism of action. Indacaterol is a long-acting beta2-adrenergic agonist (LABA) that provides sustained bronchodilation lasting at least 24 hours with a single dose. It works by activating beta2-receptors on airway smooth muscle, causing the muscles to relax and the airways to widen, making breathing easier. Unlike short-acting bronchodilators that provide temporary relief, indacaterol offers prolonged protection against bronchoconstriction.
Mometasone furoate is a potent inhaled corticosteroid (ICS) that acts locally within the airways to reduce inflammation. It suppresses the production of inflammatory mediators including cytokines, chemokines, and adhesion molecules, and reduces the infiltration of inflammatory cells such as eosinophils into the airways. Over time, this leads to decreased airway hyperresponsiveness, reduced mucus production, and improved airflow. The combination of these two medications in a single inhaler simplifies the treatment regimen and may improve patient adherence.
The Breezhaler device is a dry powder inhaler (DPI) that uses capsules containing the medication. Unlike pressurised metered-dose inhalers (pMDIs), the Breezhaler is breath-actuated, meaning that the drug is released as the patient inhales through the device. This design means that no coordination between pressing a canister and inhaling is needed, which many patients find easier to use correctly. The device provides audible (a whirring sound) and visual (empty capsule) feedback to confirm that the full dose has been delivered.
Bemrist Breezhaler is a maintenance inhaler only. It should not be used to relieve sudden asthma attacks or acute episodes of breathlessness. Always have a fast-acting rescue inhaler (such as salbutamol/albuterol) readily available for emergency use. If you find yourself needing your rescue inhaler more often than usual, contact your healthcare provider as this may indicate deteriorating asthma control.
What Should You Know Before Taking Bemrist Breezhaler?
Before starting Bemrist Breezhaler, inform your doctor about all medical conditions, allergies, and medications you are taking. Certain conditions and drug interactions may affect whether this medication is safe and appropriate for you.
Contraindications
Bemrist Breezhaler must not be used if you are allergic (hypersensitive) to indacaterol, mometasone furoate, or any of the other ingredients of this medicine (including lactose monohydrate and magnesium stearate). Severe milk protein allergy is a potential concern since the capsules contain lactose derived from milk. If you have experienced a serious allergic reaction to any ingredient, you should not use this medication.
This medicine is intended for regular maintenance therapy and must not be initiated during an acute asthma attack or severe asthma exacerbation. Patients experiencing status asthmaticus or acutely deteriorating asthma should receive appropriate emergency treatment rather than starting a new maintenance inhaler.
Warnings and Precautions
Several important precautions should be considered before and during treatment with Bemrist Breezhaler. You should inform your healthcare provider if you have or have had any of the following conditions:
- Cardiovascular disorders: Heart disease, irregular heartbeat (arrhythmia), high blood pressure, or a condition called QT prolongation (a specific type of heart rhythm abnormality). Beta2-agonists may cause clinically significant cardiovascular effects including increased pulse rate, elevated blood pressure, and changes in heart rhythm (ECG changes)
- Diabetes mellitus: Beta2-agonists may cause elevations in blood glucose levels. Patients with diabetes should monitor blood glucose more closely when starting or changing doses of this medication
- Thyroid disorders: Particularly hyperthyroidism (overactive thyroid), which may be exacerbated by beta2-agonist therapy
- Low potassium levels (hypokalaemia): Beta2-agonists can reduce serum potassium levels, which may be clinically significant in some patients. This effect may be potentiated by concomitant treatment with xanthine derivatives, corticosteroids, and diuretics
- Adrenal suppression: Systemic effects of inhaled corticosteroids may occur, particularly at high doses prescribed for prolonged periods. Possible systemic effects include Cushing syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decreased bone mineral density, cataract, and glaucoma
- Infections: Inhaled corticosteroids may mask symptoms of existing infections and increase susceptibility to new respiratory infections including tuberculosis, fungal, and viral infections. Patients with active or quiescent pulmonary tuberculosis or untreated fungal, bacterial, or viral infections should be closely monitored
- Osteoporosis: Long-term use of inhaled corticosteroids may affect bone mineral density. Patients with risk factors for osteoporosis should be monitored appropriately
- Eye disorders: Patients should be alert to symptoms such as blurred vision, which may indicate glaucoma or cataracts. Regular eye examinations may be advisable during long-term use
In rare cases, inhaled medicines including Bemrist Breezhaler may cause paradoxical bronchospasm, which is an immediate worsening of wheezing and breathing difficulty after inhalation. If this occurs, stop using the inhaler immediately and use your rescue inhaler. Seek medical attention promptly. Your doctor may need to prescribe an alternative treatment.
Pregnancy and Breastfeeding
There is limited clinical data on the use of Bemrist Breezhaler during pregnancy. Animal studies with individual components have shown some reproductive toxicity at very high systemic exposures, though the relevance of these findings to humans at therapeutic inhaled doses is uncertain. However, poorly controlled asthma during pregnancy is associated with significant risks including pre-eclampsia, gestational diabetes, premature birth, and low birth weight.
The Global Initiative for Asthma (GINA) emphasises that maintaining adequate asthma control during pregnancy is essential for the health of both the mother and the unborn child. Stopping or reducing asthma medications during pregnancy without medical guidance is more dangerous than continuing treatment. If you are pregnant, planning to become pregnant, or breastfeeding, discuss the benefits and risks of continued treatment with your healthcare provider.
It is not known whether indacaterol or mometasone furoate pass into human breast milk. A decision should be made whether to discontinue breastfeeding or to discontinue therapy, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the mother.
How Does Bemrist Breezhaler Interact with Other Drugs?
Bemrist Breezhaler can interact with several types of medications. Always inform your doctor and pharmacist about all medicines you are currently taking, including prescription medications, over-the-counter drugs, and herbal supplements.
Drug interactions with Bemrist Breezhaler primarily involve the pharmacological actions of its two active components. Indacaterol, as a beta2-agonist, can interact with medications that affect the cardiovascular system or electrolyte balance. Mometasone furoate, as a corticosteroid metabolised by the cytochrome P450 3A4 (CYP3A4) enzyme system, can interact with drugs that inhibit or induce this enzyme.
Major Interactions
| Drug / Drug Class | Type of Interaction | Clinical Significance |
|---|---|---|
| Beta-blockers (e.g. propranolol, atenolol, carvedilol) | Pharmacological antagonism. Beta-blockers can reduce or abolish the bronchodilatory effect of indacaterol and may trigger severe bronchospasm | Avoid non-selective beta-blockers in asthma patients. If beta-blocker therapy is essential, cardioselective agents (e.g. bisoprolol) may be used with extreme caution |
| Strong CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, ritonavir, cobicistat, clarithromycin) | Inhibition of mometasone furoate metabolism, leading to increased systemic corticosteroid exposure and higher risk of adrenal suppression | Avoid co-administration when possible. If unavoidable, closely monitor for systemic corticosteroid side effects. Consider dose adjustment |
| Other LABAs (e.g. salmeterol, formoterol, vilanterol) | Additive beta2-agonist effects increasing risk of cardiovascular adverse effects (tachycardia, arrhythmias, hypokalaemia) | Do not use Bemrist Breezhaler with another LABA-containing product. This includes combination inhalers that already contain a LABA component |
| MAO inhibitors and tricyclic antidepressants | May potentiate the cardiovascular effects of beta2-agonists (increased heart rate, blood pressure changes) | Use with caution. Monitor heart rate and blood pressure. Exercise caution for 2 weeks after discontinuation of MAO inhibitors |
| QT-prolonging drugs (e.g. sotalol, amiodarone, erythromycin, certain antipsychotics) | Additive effect on QT interval prolongation, increasing risk of ventricular arrhythmias including torsades de pointes | Use with caution. Consider ECG monitoring when initiating therapy. Correct hypokalaemia before starting treatment |
Minor Interactions
| Drug / Drug Class | Type of Interaction | Clinical Significance |
|---|---|---|
| Potassium-lowering drugs (e.g. loop diuretics, thiazides, theophylline) | Additive hypokalaemic effect when combined with indacaterol | Monitor serum potassium levels, especially when initiating therapy or changing doses. Correct hypokalaemia promptly |
| Moderate CYP3A4 inhibitors (e.g. erythromycin, verapamil, diltiazem) | Moderate increase in systemic mometasone exposure | Generally safe at therapeutic doses. Monitor for signs of increased corticosteroid effect during prolonged co-administration |
| P-glycoprotein inhibitors (e.g. verapamil, ciclosporin) | May increase systemic exposure to indacaterol | No dose adjustment generally required. Monitor for increased beta2-agonist effects if clinically indicated |
What Is the Correct Dosage of Bemrist Breezhaler?
The recommended dose of Bemrist Breezhaler is one capsule (125 mcg indacaterol / 62.5 mcg mometasone furoate) inhaled once daily using the Breezhaler device. The capsule should be inhaled at the same time each day. Do not swallow the capsules.
Adults (18 years and older)
Standard Adult Dose
One capsule (containing indacaterol 125 mcg / mometasone furoate 62.5 mcg) inhaled once daily via the Breezhaler device. The dose should be taken at the same time each day, preferably in the morning or evening according to your doctor's instructions. The maximum recommended dose is one capsule per day. Do not take more than one dose in any 24-hour period.
Your healthcare provider will prescribe the lowest effective strength to maintain asthma control. Regular assessment of asthma control should be performed, and the treatment should be stepped down to the lowest effective dose once stable control is achieved. If a higher ICS dose is needed, your doctor may switch you to a different combination product with a higher corticosteroid component.
Adolescents (12-17 years)
Adolescent Dose
The same dose as adults: one capsule (125 mcg / 62.5 mcg) inhaled once daily via the Breezhaler device. Treatment in adolescents should be under the supervision of a physician experienced in the management of asthma.
Children (under 12 years)
Paediatric Use
Bemrist Breezhaler is not recommended for use in children under 12 years of age. The safety and efficacy of this medication have not been established in this age group. Your doctor will recommend an alternative appropriate treatment for younger children.
Elderly Patients
Elderly Dose
No dose adjustment is required for elderly patients. However, elderly patients may be more susceptible to certain side effects, particularly cardiovascular effects (tachycardia, palpitations) and metabolic effects (hypokalaemia, hyperglycaemia). Regular monitoring is advisable, particularly during the initial treatment period.
How to Use the Breezhaler Device
Correct inhalation technique is essential for effective drug delivery. The Breezhaler is a breath-actuated dry powder inhaler that uses hard capsules. Follow these steps carefully:
- Remove the cap: Pull off the cap of the Breezhaler inhaler. Hold the base firmly and tilt the mouthpiece to open the inhaler.
- Prepare the capsule: Remove one capsule from the blister strip only immediately before use. Place the capsule in the capsule chamber. Never place a capsule directly into the mouthpiece.
- Pierce the capsule: Close the inhaler until you hear a click. Hold the inhaler upright and press both side buttons firmly at the same time, then release them. You should hear a click as the capsule is pierced. Press the buttons only once.
- Breathe out fully: Exhale completely away from the inhaler. Do not breathe out through the mouthpiece.
- Inhale the medicine: Place the mouthpiece between your lips and close your lips firmly around it. Breathe in deeply and steadily through the mouthpiece. You should hear a whirring sound as the capsule spins. Continue inhaling as deeply as you can.
- Hold your breath: Remove the inhaler from your mouth and hold your breath for up to 10 seconds, or as long as is comfortable. Then breathe out gently.
- Check the capsule: Open the inhaler and check whether any powder remains in the capsule. If powder remains, close the inhaler and repeat the inhalation steps. Most patients empty the capsule in one or two inhalations.
- Remove and discard: Remove the empty capsule from the chamber and dispose of it. Close the inhaler and replace the cap.
- Rinse your mouth: Rinse your mouth thoroughly with water and spit out the water. Do not swallow the rinse water. This helps prevent oral thrush.
Always use the new Breezhaler device supplied with each new prescription. The capsules should only be removed from the blister immediately before use as they are sensitive to moisture. Do not store capsules in the Breezhaler device. If your inhaler appears damaged or if the mouthpiece has broken, use a new one. The capsules are for inhalation use only and must never be swallowed.
Missed Dose
If you forget to take a dose, take it as soon as you remember on the same day. However, if it is almost time for your next scheduled dose, skip the missed dose and take your next dose at the regular time. Do not take two doses on the same day to make up for a missed dose. If you miss several doses, contact your healthcare provider for advice, as your asthma control may have deteriorated.
Overdose
Taking more than the recommended dose of Bemrist Breezhaler may increase the risk and severity of side effects. Symptoms of overdose may include rapid heartbeat (tachycardia), tremor, headache, palpitations, nausea, and metabolic disturbances such as hypokalaemia and hyperglycaemia. Chronic overdose of the corticosteroid component may lead to adrenal suppression.
If you suspect an overdose, contact your healthcare provider, a poison control centre, or go to the nearest hospital emergency department immediately. There is no specific antidote for Bemrist Breezhaler overdose. Supportive and symptomatic treatment should be provided as appropriate. Cardioselective beta-blockers may be considered for the management of severe beta2-agonist effects, but should be used with extreme caution in asthma patients due to the risk of precipitating bronchospasm.
What Are the Side Effects of Bemrist Breezhaler?
Like all medicines, Bemrist Breezhaler can cause side effects, although not everybody gets them. The most commonly reported side effects include upper respiratory tract infections, headache, and oral thrush (oropharyngeal candidiasis). Most side effects are mild to moderate and tend to resolve with continued use.
The side effects listed below are based on clinical trial data and post-marketing surveillance. Side effects are classified by frequency according to the following convention:
Very Common (may affect more than 1 in 10 people)
- Upper respiratory tract infection (e.g. nasopharyngitis, pharyngitis, rhinitis)
Common (may affect up to 1 in 10 people)
- Oral thrush (oropharyngeal candidiasis) – fungal infection of the mouth and throat
- Headache
- Urinary tract infection
- Cough
- Dysphonia (hoarseness or voice changes)
- Pharyngitis (sore throat)
- Sinusitis
- Muscle spasms
- Back pain
- Gastroenteritis
Uncommon (may affect up to 1 in 100 people)
- Tachycardia (rapid heartbeat)
- Palpitations
- Tremor
- Dry mouth
- Skin rash or pruritus (itching)
- Hyperglycaemia (elevated blood sugar)
- Hypokalaemia (low potassium levels)
- Insomnia (difficulty sleeping)
- Dizziness
Rare (may affect up to 1 in 1,000 people)
- Paradoxical bronchospasm (sudden worsening of breathing immediately after inhalation)
- Angioedema (swelling of the face, lips, tongue, or throat)
- Hypersensitivity reactions (allergic reactions)
- Adrenal suppression (with prolonged high-dose use)
- Glaucoma or increased intraocular pressure
- Cataract formation
Systemic corticosteroid effects may occur with any inhaled corticosteroid, particularly when prescribed at high doses for prolonged periods. These effects are much less likely than with oral corticosteroids. They may include adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataracts, and glaucoma. These effects depend on the dose, duration of exposure, concurrent and previous corticosteroid exposure, and individual sensitivity.
Difficulty breathing or swallowing, swelling of the face, lips, tongue, or throat (signs of a severe allergic reaction), sudden worsening of breathing difficulty immediately after inhalation (paradoxical bronchospasm), severe chest pain, or a very rapid or irregular heartbeat. These may be signs of a serious side effect requiring urgent medical care.
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed above. You can also report side effects directly to your national pharmacovigilance reporting system. By reporting side effects, you can help provide more information on the safety of this medicine.
How Should You Store Bemrist Breezhaler?
Store Bemrist Breezhaler capsules in their original packaging to protect from moisture and light. Do not store above 30°C (86°F). Keep the capsules in the blister strips until immediately before use.
Proper storage of Bemrist Breezhaler is important to maintain the stability and effectiveness of the medication. Follow these storage guidelines carefully:
- Temperature: Store below 30°C (86°F). Do not freeze. Avoid exposing the capsules to extreme temperatures or direct sunlight
- Moisture protection: Keep the capsules in the original blister packaging until you are ready to use them. Do not transfer capsules to another container. Moisture can damage the dry powder formulation and reduce drug delivery
- Breezhaler device: Store the Breezhaler device in a dry place. Replace it with the new device provided with each new prescription
- Expiry date: Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of that month
- Keep out of reach of children: Store all medicines in a safe place where children cannot access them
- Disposal: Do not throw away medicines via household waste or wastewater. Ask your pharmacist about local disposal programmes for medicines you no longer need. This helps protect the environment
If a capsule appears damaged, cracked, or crumbled, do not use it. Use a new capsule instead. If you notice any change in the colour or appearance of the capsules, do not use them and consult your pharmacist.
What Does Bemrist Breezhaler Contain?
Each Bemrist Breezhaler capsule contains two active substances: indacaterol (as indacaterol acetate) and mometasone furoate. The capsule also contains several inactive ingredients (excipients) that help form the dry powder formulation.
Active Ingredients
The available strength contains the following active ingredients per capsule:
- Indacaterol acetate – equivalent to 125 micrograms of indacaterol (delivered dose at the mouthpiece may be lower depending on inhalation technique)
- Mometasone furoate – 62.5 micrograms
Inactive Ingredients (Excipients)
The other ingredients in the capsule contents include:
- Lactose monohydrate – a sugar derived from milk that serves as a carrier for the drug particles. Patients with severe lactose intolerance or galactose intolerance should discuss this with their doctor before use
- Magnesium stearate – a lubricant that helps the powder flow smoothly from the capsule during inhalation
The hard capsule shell is composed of hypromellose (HPMC) and may contain iron oxide pigments and titanium dioxide as colouring agents. These inactive ingredients do not have any pharmacological effect at the amounts present in the formulation.
Frequently Asked Questions About Bemrist Breezhaler
Bemrist Breezhaler is unique in that it offers once-daily dosing, unlike many other ICS/LABA combination inhalers that require twice-daily administration (such as fluticasone/salmeterol or budesonide/formoterol). The Breezhaler device is a dry powder inhaler that uses individual capsules and provides audible and visual confirmation of dose delivery. This can help patients feel more confident that they have received their full dose. The combination of indacaterol (which provides 24-hour bronchodilation) and mometasone furoate (a potent anti-inflammatory corticosteroid) provides comprehensive asthma control with a single daily inhalation.
Bemrist Breezhaler is specifically approved for asthma maintenance treatment. It is not approved for the treatment of COPD. If you have COPD, your healthcare provider may prescribe different combination products that are specifically approved for this condition. Some patients may have features of both asthma and COPD (sometimes called asthma-COPD overlap), and in these cases your doctor will determine the most appropriate treatment regimen. Do not use Bemrist Breezhaler for any condition other than that for which it was prescribed.
Rinsing your mouth with water after each inhalation is important because the inhaled corticosteroid component (mometasone furoate) can deposit on the surfaces of the mouth and throat. This local corticosteroid exposure can promote the growth of the fungus Candida albicans, leading to oral thrush (oropharyngeal candidiasis), which appears as white patches in the mouth and throat, and can also cause hoarseness (dysphonia). By rinsing your mouth thoroughly with water and spitting it out (not swallowing), you remove most of the deposited corticosteroid and significantly reduce the risk of developing these local side effects.
If you do not hear a whirring sound during inhalation, the capsule may be stuck in the capsule chamber. Open the inhaler and gently tap to free the capsule, but do not press the piercing buttons again. Close the inhaler and try inhaling again. If powder remains in the capsule after your first inhalation, close the inhaler and repeat the inhalation. Most patients empty the capsule in one or two inhalations. Ensure you are inhaling quickly and deeply enough to generate sufficient airflow through the device. If you continue to have difficulty, contact your doctor or pharmacist for guidance on proper inhalation technique.
No, you should not stop taking Bemrist Breezhaler on your own, even if you feel better. Asthma is a chronic condition, and the absence of symptoms usually means the medication is working effectively to control the underlying inflammation and bronchoconstriction. Stopping treatment abruptly can lead to a return of symptoms and potentially a serious asthma exacerbation. Your doctor will regularly review your treatment and may gradually step down your medication if your asthma has been well controlled for a sustained period. Any changes to your treatment should be made under medical supervision according to GINA guidelines for step-down therapy.
There is limited clinical data on the use of Bemrist Breezhaler during pregnancy. However, the GINA guidelines strongly recommend that pregnant women with asthma continue their asthma medications, as the risks of uncontrolled asthma to both mother and baby (including pre-eclampsia, premature birth, and low birth weight) generally outweigh the potential risks of the medication. Your doctor will assess the benefits versus risks for your individual situation. Never stop taking your asthma medication during pregnancy without consulting your healthcare provider first.
References
This article is based on the following peer-reviewed sources and international guidelines:
- Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention. Updated 2024. Available at: ginasthma.org
- European Medicines Agency (EMA). Bemrist Breezhaler Summary of Product Characteristics (SmPC). European Public Assessment Report.
- World Health Organization (WHO). WHO Model List of Essential Medicines, 23rd List, 2023.
- British National Formulary (BNF). Indacaterol with mometasone furoate. National Institute for Health and Care Excellence (NICE).
- Kerstjens HAM, Maspero J, Chapman KR, et al. Once-daily, single-inhaler mometasone-indacaterol-glycopyrronium versus mometasone-indacaterol or fluticasone-salmeterol in patients with inadequately controlled asthma (IRIDIUM): a randomised, double-blind, controlled phase 3 study. Lancet Respir Med. 2020;8(10):1000-1012.
- Buhl R, Acquier A, Engel M, et al. Improved asthma control with mometasone furoate/indacaterol versus mometasone furoate: a phase III study. Eur Respir J. 2021;57(2):2003120.
- Reddel HK, Bacharier LB, Bateman ED, et al. Global Initiative for Asthma Strategy 2021: executive summary and rationale for key changes. Eur Respir J. 2022;59(1):2102730.
- National Asthma Education and Prevention Program (NAEPP). Expert Panel Report 4: Guidelines for the Diagnosis and Management of Asthma. National Heart, Lung, and Blood Institute (NHLBI), 2020.
About the Medical Editorial Team
This article has been written and reviewed by the iMedic Medical Editorial Team, comprising licensed physicians with specialist qualifications in respiratory medicine and clinical pharmacology. All content follows the GRADE evidence framework and is based on systematic reviews, randomised controlled trials, and international clinical guidelines (GINA, EMA, WHO, BNF).
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