Bretaris Genuair (Aclidinium Bromide)
Long-acting muscarinic antagonist (LAMA) inhaler for maintenance treatment of COPD
Bretaris Genuair is a prescription inhaler containing aclidinium bromide, a long-acting muscarinic antagonist (LAMA) used as maintenance treatment for chronic obstructive pulmonary disease (COPD) in adults. Delivered via the Genuair dry-powder inhaler device, it provides sustained bronchodilation to improve airflow, reduce breathlessness, and help prevent COPD exacerbations. It is not intended for acute symptom relief or for use in asthma.
Quick Facts
Key Takeaways
- Bretaris Genuair contains aclidinium bromide 322 mcg, a long-acting anticholinergic bronchodilator inhaled twice daily for COPD maintenance therapy.
- Clinical trials (ACCLAIM/COPD, ATTAIN) demonstrated significant improvements in lung function (FEV1), symptom scores, and quality of life compared to placebo.
- Aclidinium is rapidly hydrolyzed in plasma, resulting in very low systemic anticholinergic exposure and a favorable side effect profile compared to some other LAMAs.
- The Genuair device features a built-in dose indicator and color-coded feedback window (green to red) to confirm successful inhalation.
- It should not be used as rescue medication for sudden breathing problems; a short-acting bronchodilator (such as salbutamol) should be kept available for acute relief.
What Is Bretaris Genuair and What Is It Used For?
Bretaris Genuair belongs to the pharmacological class of long-acting muscarinic antagonists (LAMAs), also known as long-acting anticholinergics. The active substance, aclidinium bromide, works by blocking muscarinic M3 receptors on airway smooth muscle cells. Under normal conditions, the neurotransmitter acetylcholine activates these receptors, causing the airway muscles to contract and narrow the bronchi. By blocking this action, aclidinium causes the muscles to relax, resulting in sustained bronchodilation — widening of the airways — which improves airflow to the lungs.
COPD is a chronic, progressive respiratory disease characterized by persistent airflow limitation that is not fully reversible. It encompasses conditions such as chronic bronchitis (inflammation and excess mucus in the bronchial tubes) and emphysema (destruction of the lung's alveoli). Patients typically experience worsening breathlessness, chronic cough, and sputum production. According to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2024 Report, COPD is the third leading cause of death worldwide, and long-acting bronchodilators are central to its pharmacological management.
Aclidinium bromide was developed to address some limitations of earlier anticholinergic agents. Its pharmacokinetic profile is notable for rapid plasma hydrolysis, which means that any aclidinium absorbed systemically is quickly broken down into inactive metabolites. This property is associated with lower systemic anticholinergic effects (such as dry mouth, urinary retention, and cardiovascular effects) compared to some other agents in the class. The twice-daily dosing regimen also provides consistent bronchodilation throughout a full 24-hour period, with each dose maintaining effect for approximately 12 hours.
The Genuair (also marketed as Pressair in some regions) inhaler device is a multi-dose dry-powder inhaler engineered for ease of use. It features a color-coded control window that changes from green to red after a successful inhalation, a dose counter, and a mechanism that prevents double-dosing. These design features were developed to address the common problem of incorrect inhaler technique, which is a leading cause of suboptimal COPD treatment outcomes. Studies have demonstrated that patients find the Genuair device easier to use correctly compared to some other dry-powder inhalers.
Bretaris Genuair is approved in the European Union (as Bretaris Genuair and Eklira Genuair), the United States (as Tudorza Pressair), and numerous other countries worldwide. It is indicated exclusively for adults with COPD and is not approved for the treatment of asthma. It is a maintenance therapy and must not be used as a rescue inhaler for acute episodes of breathlessness.
What Should You Know Before Taking Bretaris Genuair?
Bretaris Genuair is a powerful bronchodilator, but like all medicines it has important precautions and contraindications. Understanding these before starting treatment can help you and your healthcare provider make informed decisions about whether this medicine is appropriate for your individual circumstances.
Contraindications
You should not use Bretaris Genuair if you are allergic (hypersensitive) to aclidinium bromide or any of the other ingredients in the product (including lactose monohydrate). Signs of a severe allergic reaction may include rash, hives, swelling of the face, lips, tongue or throat, and difficulty breathing. If you experience any of these symptoms, stop using the inhaler and seek emergency medical care immediately.
There are no absolute contraindications based on specific medical conditions beyond hypersensitivity. However, several conditions require careful assessment by your prescriber before treatment is initiated.
Warnings and Precautions
Special care is needed if you have any of the following conditions:
- Narrow-angle glaucoma: Anticholinergic medicines can increase intraocular pressure and potentially trigger or worsen acute narrow-angle glaucoma. If you experience eye pain, blurred vision, visual halos, or colored images in association with red eyes after using Bretaris Genuair, stop the medicine and seek urgent ophthalmological assessment.
- Prostatic hyperplasia or bladder-neck obstruction: Anticholinergic agents can cause or worsen urinary retention. If you have difficulty passing urine or notice reduced urine flow, contact your doctor.
- Severe renal impairment (creatinine clearance <30 mL/min): While aclidinium is primarily metabolized by hydrolysis (not the kidneys), limited data are available in patients with severe kidney disease. Use with caution and under close medical supervision.
- Cardiac conditions: Although clinical trials did not show significant cardiovascular safety concerns, patients with unstable ischaemic heart disease, recent myocardial infarction (within 6 months), recent hospitalization for heart failure, or a history of life-threatening cardiac arrhythmias were excluded from pivotal studies. Use in these populations should be based on individual risk-benefit assessment.
Bretaris Genuair is a maintenance medicine and should not be used to treat sudden attacks of breathlessness or wheezing. Always carry a separate short-acting bronchodilator (such as salbutamol/albuterol) for acute symptom relief. If your rescue inhaler becomes less effective or you need it more frequently, contact your doctor as this may indicate worsening COPD.
Pregnancy and Breastfeeding
There are no adequate or well-controlled studies of Bretaris Genuair in pregnant women. Animal reproductive toxicity studies did not reveal direct harmful effects at clinically relevant doses. However, as a precautionary measure, Bretaris Genuair should preferably be avoided during pregnancy unless the expected benefit to the mother justifies the potential risk to the fetus.
It is unknown whether aclidinium bromide or its metabolites are excreted in human breast milk. In animal studies, aclidinium and its metabolites were detected in the milk of lactating rats. A decision must be made whether to discontinue breastfeeding or to discontinue treatment with Bretaris Genuair, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the mother. Discuss this with your healthcare provider.
With regard to fertility, preclinical studies in animals did not show adverse effects on fertility at therapeutic doses. There are no human data available.
How Does Bretaris Genuair Interact with Other Drugs?
Drug interactions with Bretaris Genuair are relatively limited, largely because aclidinium bromide is rapidly hydrolyzed in plasma and has minimal systemic bioavailability. This pharmacokinetic characteristic reduces the potential for systemic drug-drug interactions. Nevertheless, there are important considerations when combining Bretaris Genuair with other medications, particularly other anticholinergic agents.
No formal drug interaction studies have revealed clinically significant interactions with commonly used COPD co-medications. Aclidinium does not inhibit or induce major cytochrome P450 enzymes, and it is not a substrate for hepatic metabolism to a significant extent. Its primary route of inactivation is ester hydrolysis in plasma, which is a non-enzymatic, non-saturable process.
Major Interactions
| Drug / Class | Interaction Type | Clinical Significance | Recommendation |
|---|---|---|---|
| Other LAMAs (tiotropium, umeclidinium, glycopyrronium) | Additive anticholinergic effects | Increased risk of dry mouth, urinary retention, constipation, tachycardia, and raised intraocular pressure without added bronchodilator benefit | Avoid combination |
| Short-acting anticholinergics (ipratropium bromide) | Additive anticholinergic effects | Increased systemic anticholinergic burden; limited additional bronchodilation | Avoid regular co-administration; occasional use may be acceptable under medical supervision |
| Systemic anticholinergics (oxybutynin, tolterodine, atropine) | Additive systemic anticholinergic effects | May increase risk of urinary retention, constipation, dry mouth, cognitive impairment (especially in elderly) | Use with caution; monitor for anticholinergic burden |
Minor Interactions and Safe Combinations
| Drug / Class | Interaction | Notes |
|---|---|---|
| LABAs (formoterol, salmeterol, indacaterol) | No clinically significant interaction | LAMA + LABA is a well-established combination in COPD. Aclidinium/formoterol fixed combination (Duaklir Genuair) is available. |
| Inhaled corticosteroids (ICS) (budesonide, fluticasone) | No interaction | Triple therapy (LAMA + LABA + ICS) may be indicated for patients with frequent exacerbations. |
| Short-acting beta-2 agonists (salbutamol/albuterol) | No interaction | Patients should keep a SABA available for acute symptom relief while on Bretaris Genuair. |
| Theophylline | No clinically significant interaction | Can be used concomitantly. Theophylline monitoring should follow standard practice. |
| Oral corticosteroids (prednisolone) | No interaction | May be used during COPD exacerbations alongside ongoing Bretaris Genuair treatment. |
Aclidinium bromide has an absolute pulmonary bioavailability of approximately 30% and negligible oral bioavailability (<5%). Once absorbed, it is rapidly and extensively hydrolyzed in plasma (half-life of hydrolysis approximately 2–3 minutes) to two major inactive metabolites: a carboxylic acid derivative and an alcohol derivative. This rapid inactivation means systemic drug interactions are unlikely, and dose adjustments are not typically required in hepatic impairment.
What Is the Correct Dosage of Bretaris Genuair?
Bretaris Genuair is supplied in a pre-loaded multi-dose dry-powder inhaler containing 60 doses. Each actuation delivers a metered dose of 375 micrograms of aclidinium bromide, which corresponds to a delivered dose of 322 micrograms from the mouthpiece. The dosing regimen is straightforward, with the same dose used for all adults regardless of COPD severity, age, or body weight.
Adults
Standard Adult Dose
322 micrograms (one inhalation) twice daily
Take one inhalation in the morning and one in the evening, approximately 12 hours apart. Try to use the inhaler at the same times each day for consistent bronchodilation. The maximum recommended dose is 322 micrograms twice daily — do not exceed two inhalations per day.
It is important to use Bretaris Genuair regularly, even when you feel well, as it is a maintenance medication. Stopping treatment may result in a gradual return of COPD symptoms. If you feel your breathing is not improving or is getting worse, contact your healthcare provider rather than increasing the dose.
Children and Adolescents
Paediatric Use
Bretaris Genuair is not indicated for use in children or adolescents under 18 years of age. COPD is a condition that typically affects adults, usually those over 40 years of age with a significant smoking history or occupational/environmental exposure. There is no relevant use of aclidinium bromide in the paediatric population for this indication.
Elderly Patients
Elderly Dose (65 years and older)
No dose adjustment required. In clinical trials, a significant proportion of patients were elderly, and no differences in efficacy or safety were observed between older and younger adults. However, elderly patients may be more susceptible to anticholinergic side effects (such as dry mouth, constipation, and urinary retention), so monitoring is advisable.
Renal and Hepatic Impairment
Dose Adjustments for Organ Impairment
Mild-to-moderate renal impairment: No dose adjustment needed. Aclidinium is eliminated primarily by chemical hydrolysis, not renal excretion.
Severe renal impairment (CrCl <30 mL/min): Use with caution; limited data available.
Hepatic impairment: No dose adjustment required. Aclidinium is not metabolized hepatically to a clinically relevant extent.
Missed Dose
If you forget to take a dose, take it as soon as you remember. However, if it is nearly time for your next dose, skip the missed dose and take the next one at the regular time. Do not take a double dose to make up for a forgotten dose. Continue with your normal twice-daily schedule.
Overdose
No cases of clinically significant overdose have been reported with aclidinium bromide. High doses of anticholinergic medicines may theoretically produce anticholinergic symptoms including dry mouth, visual disturbances, increased heart rate, urinary retention, and decreased gastrointestinal motility. In preclinical studies, single inhaled doses up to 6,000 micrograms (approximately 20 times the therapeutic dose) did not produce systemic anticholinergic effects, likely due to rapid plasma hydrolysis.
If you suspect an overdose, contact your doctor, pharmacist, or poison control center immediately. Treatment would be supportive and symptomatic.
How to Use the Genuair Inhaler
Correct inhaler technique is essential for effective treatment. The Genuair device is designed to be intuitive, but the following steps should be followed:
- Remove the cap: Press the arrows on each side of the cap firmly and pull it off. Check that the control window is green and the dose counter shows remaining doses.
- Prepare the dose: Hold the inhaler horizontally with the mouthpiece facing you and the green button on top. Press the green button fully down, then release it before inhaling. The control window should remain green.
- Inhale the dose: Breathe out gently (away from the inhaler). Place your lips tightly around the mouthpiece and breathe in strongly and deeply through your mouth. You will hear a “click” sound confirming the dose release.
- Hold your breath: Remove the inhaler from your mouth and hold your breath for as long as comfortable (ideally 5–10 seconds), then breathe out slowly.
- Confirm inhalation: Check that the control window has turned from green to red, confirming a full dose was successfully inhaled. If the window remains green, repeat the inhalation.
- Replace the cap: Put the protective cap back on the mouthpiece after use.
Unlike pressurized metered-dose inhalers, the Genuair device is breath-actuated — you do not need to coordinate pressing a button with breathing in. Simply prepare the dose by pressing and releasing the green button, then inhale strongly. The device does the rest. If the control window does not turn red, you may not have inhaled forcefully enough; try again with a stronger breath.
What Are the Side Effects of Bretaris Genuair?
Like all medicines, Bretaris Genuair can cause side effects, although not everyone experiences them. In clinical trials involving over 2,500 patients treated with aclidinium bromide 322 micrograms twice daily, the overall incidence of adverse events was comparable to placebo, reflecting the drug's favorable safety profile. The rapid plasma hydrolysis of aclidinium limits systemic exposure, which contributes to a lower incidence of typical anticholinergic side effects compared to some other LAMA agents.
The side effects are listed below according to their frequency of occurrence, based on data from clinical trials and post-marketing surveillance. Understanding these frequencies can help you distinguish between common, expected reactions and rarer events that may require medical attention.
Common
May affect up to 1 in 10 people
- Headache
- Nasopharyngitis (common cold, runny or stuffy nose)
- Cough
- Diarrhea
- Sinusitis (sinus infection)
Uncommon
May affect up to 1 in 100 people
- Dry mouth (xerostomia)
- Blurred vision
- Tachycardia (fast heartbeat)
- Palpitations
- Dysphonia (hoarseness, voice changes)
- Nausea
- Oral candidiasis (thrush in the mouth)
- Dizziness
- Urinary retention (difficulty emptying the bladder)
- Pruritus (itching)
- Rash
Rare
May affect up to 1 in 1,000 people
- Hypersensitivity reactions (including angioedema)
- Paradoxical bronchospasm (sudden narrowing of the airways after inhalation)
- Increased intraocular pressure
- Atrial fibrillation
Stop using Bretaris Genuair and seek emergency medical help if you experience: sudden worsening of breathing (paradoxical bronchospasm) immediately after using the inhaler; swelling of the face, lips, tongue or throat with difficulty swallowing or breathing (angioedema); severe eye pain with redness and blurred vision or visual halos (acute glaucoma); or severe chest pain with irregular or very fast heartbeat.
In long-term safety studies extending up to 52 weeks, the adverse event profile remained consistent with shorter-term data, with no new safety signals emerging. Anticholinergic side effects, particularly dry mouth, were reported less frequently with aclidinium than in comparative studies with tiotropium, which is likely attributable to the rapid systemic inactivation of aclidinium.
If you experience any side effects, including those not listed here, talk to your doctor or pharmacist. You can also report side effects to your national adverse drug reaction reporting system (for example, the Yellow Card Scheme in the UK, MedWatch in the US, or EudraVigilance in the EU).
How Should You Store Bretaris Genuair?
Proper storage of Bretaris Genuair is essential to maintain the efficacy and stability of the medication. The inhalation powder is sensitive to moisture, and incorrect storage can lead to clumping or degradation of the active substance, resulting in reduced therapeutic effect.
- Temperature: Store below 25°C (77°F). Do not freeze. Brief exposure to temperatures up to 30°C during travel or handling is generally acceptable, but prolonged exposure to high temperatures should be avoided.
- Moisture protection: Keep the inhaler in the sealed pouch provided by the manufacturer until you are ready to use it for the first time. Once removed from the pouch, the inhaler should be used within 90 days. The protective cap should always be replaced after each use to prevent moisture ingress.
- Light: Protect from direct sunlight. Store in a cool, dry place away from windows and heat sources.
- Keep out of reach and sight of children.
- Do not use the inhaler after the expiry date printed on the carton and the label of the inhaler. The expiry date refers to the last day of that month.
- Do not throw the inhaler in a fire or puncture the device, even when empty.
The dose counter on the Genuair inhaler indicates the approximate number of doses remaining. When the counter shows a red band (approximately 0 remaining), discard the inhaler and start a new one, even if you think there may still be medication inside. The device is designed to lock after the last marked dose to prevent use of potentially inaccurate or empty doses.
Do not attempt to disassemble, wash, or clean the inside of the Genuair inhaler. The mouthpiece can be wiped with a dry tissue if needed. Do not use water or other liquids on any part of the inhaler as this can damage the dry powder formulation.
What Does Bretaris Genuair Contain?
The formulation of Bretaris Genuair is deliberately simple, consisting of the active substance and a single excipient:
- Active substance: Aclidinium bromide — 375 micrograms metered dose per actuation, delivering 322 micrograms from the mouthpiece. Aclidinium bromide is a synthetic quaternary ammonium compound with the chemical name (3R)-3-{[hydroxy(di-2-thienyl)acetyl]oxy}-1-(3-phenoxypropyl)-1-azoniabicyclo[2.2.2]octane bromide. Its molecular formula is C26H30BrNO4S2 with a molecular weight of 564.56 g/mol.
- Excipient: Lactose monohydrate — used as a carrier to facilitate the delivery of the fine-particle drug through the inhaler device and into the lungs. Lactose monohydrate contains small amounts of milk protein.
The lactose monohydrate in Bretaris Genuair contains small amounts of milk proteins. If you have a severe allergy to milk proteins (not lactose intolerance, which is different), you should discuss this with your doctor before using this medicine. Most patients with lactose intolerance can use this inhaler without problems, as the amount of lactose is very small and it is delivered to the lungs, not ingested orally in significant quantities.
Each Genuair inhaler contains 60 doses and is intended for single-patient use only. The device is made from acrylonitrile butadiene styrene (ABS) plastic with a stainless-steel spring mechanism. The mouthpiece incorporates a low-resistance design that is suitable for use by patients with moderate-to-severe COPD who may have reduced inspiratory flow rates.
Frequently Asked Questions About Bretaris Genuair
Bretaris Genuair (aclidinium bromide 322 micrograms) is a long-acting muscarinic antagonist (LAMA) inhaler used as maintenance bronchodilator treatment for chronic obstructive pulmonary disease (COPD) in adults. It relieves symptoms such as breathlessness, wheezing, and coughing by relaxing airway smooth muscle. It is not intended for the relief of acute bronchospasm or for the treatment of asthma.
To use the Genuair inhaler: (1) Remove the protective cap by pressing the arrows on each side and pulling. (2) Hold the inhaler horizontally with the green button facing up. (3) Press the green button all the way down, then release before inhaling. (4) Place your lips around the mouthpiece and inhale strongly and deeply through your mouth. (5) Hold your breath for as long as is comfortable. (6) Check that the control window has changed from green to red, confirming a full dose was inhaled. (7) Replace the protective cap.
The most common side effects of Bretaris Genuair include headache, nasopharyngitis (inflammation of the nose and throat), cough, diarrhea, and sinusitis. These are generally mild to moderate and often resolve as the body adjusts to the medicine. Less common side effects include dry mouth, blurred vision, urinary retention, and tachycardia. Seek medical attention immediately if you experience signs of a severe allergic reaction or paradoxical bronchospasm.
Yes, Bretaris Genuair can generally be used alongside other COPD medicines such as inhaled corticosteroids (ICS), long-acting beta-2 agonists (LABAs), and short-acting bronchodilators for acute relief. However, it should not be combined with other long-acting anticholinergic (LAMA) medicines such as tiotropium or umeclidinium, as this can increase the risk of anticholinergic side effects without additional bronchodilator benefit. Always consult your doctor about combining treatments.
There are limited data on the use of Bretaris Genuair during pregnancy. Animal studies have not shown direct harmful effects on reproductive toxicity. However, as a precaution, Bretaris Genuair should preferably be avoided during pregnancy unless the expected benefit to the mother outweighs any potential risk to the fetus. It is also unknown whether aclidinium is excreted in human breast milk, so breastfeeding mothers should discuss use with their doctor.
Bretaris Genuair has a relatively rapid onset of action for a long-acting bronchodilator. Clinical studies have shown statistically significant improvements in lung function (FEV1) within 30 minutes of the first dose, with peak effect occurring at approximately 2 hours post-dose. However, it is a maintenance medicine and the full benefit develops over days of regular use. It should not be used as a rescue inhaler for sudden breathlessness.
References
All medical information in this article is based on peer-reviewed research and international clinical guidelines. The following sources were used:
- European Medicines Agency (EMA). Bretaris Genuair – Summary of Product Characteristics (SmPC). EMA/CHMP, last updated 2024. Available at: www.ema.europa.eu
- Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease: 2024 Report. Available at: goldcopd.org
- Jones PW, Singh D, Bateman ED, et al. Efficacy and safety of twice-daily aclidinium bromide in COPD patients: the ATTAIN study. European Respiratory Journal. 2012;40(4):830–836. doi:10.1183/09031936.00225511
- Kerwin EM, D'Urzo AD, Gelb AF, et al. Efficacy and safety of a 12-week treatment with twice-daily aclidinium bromide in COPD patients (ACCORD COPD I). COPD. 2012;9(2):90–101. doi:10.3109/15412555.2012.661492
- Rennard SI, Scanlon PD, Ferguson GT, et al. ACCLAIM/COPD II: a randomized clinical trial to evaluate the 12-week efficacy and safety of twice-daily aclidinium bromide in COPD patients. Clinical Drug Investigation. 2013;33(12):893–904. doi:10.1007/s40261-013-0138-1
- British National Formulary (BNF). Aclidinium bromide. National Institute for Health and Care Excellence (NICE). Available at: bnf.nice.org.uk
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd List (2023). Geneva: World Health Organization; 2023.
- Fuhr R, Magnussen H, Sarem K, et al. Efficacy of aclidinium bromide 400 μg twice daily compared with placebo and tiotropium in patients with moderate to severe COPD. Chest. 2012;141(3):745–752. doi:10.1378/chest.11-0406
Editorial Team
This article has been developed and reviewed by the iMedic Medical Editorial Team, which includes licensed physicians specializing in respiratory medicine, clinical pharmacology, and pulmonary care. Our content follows the GRADE evidence framework and is based on the highest quality of available evidence (Level 1A: systematic reviews and randomized controlled trials).
Written by iMedic Medical Editorial Team – specialists in respiratory medicine and clinical pharmacology with extensive experience in COPD management.
Reviewed by iMedic Medical Review Board – an independent panel of medical experts ensuring content accuracy according to EMA, GOLD, WHO, and BNF guidelines.
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