Inuxair

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Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Inuxair

Property Description
Active ingredient Beclometasone dipropionate and Formoterol fumarate dihydrate
Form Pressurised inhalation solution or inhalation powder
Pharmacological class Adrenergics and corticosteroids (combination agent)
General use Maintenance therapy for obstructive airway diseases
Origin Synthetic

Inuxair: Defining the Combination Medicine

Inuxair is a fixed-dose combination product containing two distinct synthetic active substances, classifying it within the pharmacological class of Adrenergics and corticosteroids. This medicinal entity is a single-inhaler system designed to provide consistent, simultaneous therapy from both a long-term preventive component and a long-acting quick-acting component. This type of combination therapy is clinically recognized for its efficacy in providing sustained therapeutic support for compromised air passages. The fixed-dose strategy offers a unified approach to the management of chronic breathing conditions, often being marketed under the trade names Fostair or Innovair in various regions.

Composition and Physical Form of Inuxair

The preparation's core composition consists of Beclometasone dipropionate and Formoterol fumarate dihydrate as the active ingredients. Beclometasone dipropionate is a potent inhaled corticosteroid (ICS), acting as a prodrug to an active anti-inflammatory metabolite, while Formoterol fumarate dihydrate is a long-acting beta2 agonist (LABA). A differentiating feature is its formulation as an extra-fine aerosol, designed to ensure delivery of the particles deep into the peripheral small airways. Inuxair is supplied as a pressurised inhalation solution or an inhalation powder, with the required Route of administration strictly by local inhalation, ensuring the medicine is delivered directly to the target tissue.

General Purpose: How the Dual Action Benefits the Airways

The primary purpose of this fixed combination is to provide sustained therapeutic support by delivering complementary physiological actions. The Beclometasone component provides a glucocorticoid anti-inflammatory action that works to suppress and reduce the underlying chronic swelling and irritation within the air passages. Concurrently, the Formoterol component provides a bronchodilator effect by relaxing the muscles that constrict the airways, resulting in sustained widening and improved airflow. This dual mechanism is crucial for maintaining stable lung function and offering continuous control over difficulty breathing, serving as a typical maintenance therapy for patients with obstructive airway diseases.

What side effects are possible with Inuxair?

Possible Side Effects and Safety Information

The safety profile for Inuxair (reslizumab) is organized by the severity and frequency of adverse reactions observed in controlled clinical studies, as documented in regulatory sources.

Serious Adverse Reactions

Official regulatory documentation highlights that Anaphylaxis is a serious and potentially life-threatening adverse reaction. This reaction has been reported to occur during or shortly after the infusion. Administration of the medicine is restricted to a healthcare setting by professionals prepared to manage anaphylaxis. Additionally, Malignancy (cancer) was observed in a small number of patients receiving the medicine in clinical trials.

Most Common Adverse Reaction

Side effects are categorized by frequency, which is based on their incidence in clinical trials. The most common adverse reaction, defined by a regulatory threshold of ge 2%, is oropharyngeal pain.

System-Organ Class Affected Examples of Adverse Reactions
General Disorders / Oropharyngeal Oropharyngeal pain
Immune System Disorders Anaphylaxis (Serious)

Safety-Related Restrictions and Considerations

The following safety notes from official documents structure the use of this medicine:

  • Hypersensitivity: The medicine is contraindicated in patients with a known hypersensitivity to the drug or its components.
  • Parasitic Infection: Patients with pre-existing helminth (parasitic) infections should be treated before beginning therapy. If an infection is acquired and does not resolve with treatment, the medicine should be discontinued until the parasitic infection is resolved.
  • Corticosteroid Use: Patients receiving systemic or inhaled corticosteroids must not abruptly discontinue them upon initiation of this therapy; any reduction must be gradual.

The official safety documentation structures the understanding of risks by clearly separating common, expected adverse reactions from serious, critical events like anaphylaxis and malignancy, which require specific risk mitigation measures.

Overdose and Emergency Response

Overdose and when to seek help — Official Regulatory Information for Inuxair


Overdose Scope

Property Official Regulatory Statement
Documented overdose presentations Overdose primarily presents with signs of excessive beta2-adrenergic stimulation due to Formoterol, including tachycardia, palpitations, tremor, and headache. Metabolic abnormalities such as hypokalaemia and hyperglycaemia are also documented.
Physiological systems affected (as stated in label) Cardiovascular system, Metabolic system, and the Hypothalamic-Pituitary-Adrenal (HPA) axis (for chronic high-dose exposure).
Dose-related or exposure-related factors (if applicable) Acute overdose relates to high Formoterol exposure. Chronic overdose involves prolonged high doses of Beclometasone, risking adrenal suppression.
Population-specific overdose notes (if applicable) No specific population is noted in regulatory sections as having unique or disproportionately severe overdose outcomes.
Emergency-response statements (as written in official documents) Management should be symptomatic and supportive. Cardioselective beta-blocking agents may be considered, maintaining caution due to the risk of inducing bronchospasm.
When immediate medical help is required (label-derived phrasing only) Urgent medical assessment must be undertaken for sudden and progressive deterioration in control of the underlying respiratory condition.

Overdose Classifications (High-Level)

Property Official Regulatory Statement
Severity classification (as defined in official documents) The potential for cardiac arrhythmias and severe metabolic imbalance defines the overdose as potentially severe or life-threatening under certain conditions.
Regulatory basis (EMA / FDA / etc.) Summary of Product Characteristics (SmPC) / Prescribing Information.
Overdose-context constraints (as defined in official documents) Management focuses on supportive care, as no specific antidote is known for the combination.

Resulting Overdose Structure

Official overdose statements:

  • Overdose may result in clinical signs including tachycardia, palpitations, and tremor.
  • Mandated monitoring of serum potassium and blood glucose levels is required due to the risk of hypokalaemia and hyperglycaemia.
  • Urgent medical assessment is required for sudden and progressive deterioration in symptoms.

Connection to the overall overdose profile

Regulatory documentation defines the overdose profile by separating acute Formoterol-driven sympathomimetic effects from chronic Beclometasone-driven HPA axis suppression. This structure details the required response, emphasizing close observation of cardiovascular and metabolic status, and mandates that specific clinical signs of worsening respiratory control trigger an urgent call for medical assessment.

Therapeutic Uses of Inuxair

What Inuxair Treats: Main Uses and Benefits

Inuxair is a combination treatment commonly used across conditions involving chronic respiratory issues, primarily to help manage asthma and COPD (Chronic Obstructive Pulmonary Disease). The medication is applied in clinical settings that require additional symptomatic support for conditions presenting with chronic, episodic, or fluctuating symptom patterns.

It is relevant for managing symptoms related to physical discomfort and systemic imbalance, such as shortness of breath, tightness in the chest, and wheezing. The core purpose is long-term management to help maintain stability, especially during phases when symptoms become temporarily overwhelming or more noticeable. This provides support that helps ease the overall symptom burden and contributes to easing the overall symptom load during periods of heightened symptoms.

“The treatment may assist in maintaining functional stability for patients dealing with disruptive symptom manifestations.”


Quick Fact: Support for Symptoms of Breathlessness

Eligibility and Restrictions for Use

Who Can and Cannot Use Inuxair?

The population eligibility for Inuxair is strictly defined by regulatory documents and depends on age, pre-existing health conditions, and physiological status.


Populations Allowed or Not Recommended

Category Eligibility Rule (Official Labeling)
Eligible Age Group Adults (18 years and older) are the approved population for maintenance therapy.
Geriatric Patients No dose adjustment is typically required for older adults (65+).
Pediatric Use Not recommended for children and adolescents under 18 years of age.

Absolute Contraindications

Inuxair must not be used in the following situations:

  • Hypersensitivity: In patients with known allergy to the active substances (beclometasone dipropionate or formoterol fumarate dihydrate) or any excipients.
  • Acute Episodes: It is contraindicated for treating an acute episode of bronchospasm or an acute exacerbation; it is not a rescue inhaler.

Use Requiring Caution

Patients with certain pre-existing conditions must use this medication under close monitoring, including those with specific cardiac arrhythmias, severe heart failure, thyrotoxicosis, diabetes mellitus, and untreated hypokalaemia. Regulatory information also notes that use is not established for patients with severe hepatic (liver) or renal (kidney) impairment due to a lack of data.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Inuxair contains budesonide (a corticosteroid) and formoterol (a long-acting beta-agonist), which are subject to specific interactions with other medicines and product categories. These interactions are categorized based on their mechanism and potential severity.


Pharmacokinetic and Pharmacodynamic Interactions

Interacting Medicine Category Interaction Mechanism & Effect Classification
Strong CYP3A4 Inhibitors (e.g., ketoconazole, ritonavir, clarithromycin) Inhibits budesonide metabolism, increasing its systemic exposure, which raises the risk of corticosteroid-related side effects. Avoid unless benefit outweighs risk
Beta-adrenergic Blocking Agents (Beta-blockers) Antagonizes formoterol’s beta2-agonist effect, which can reduce bronchodilation and may provoke severe bronchospasm. Use with Caution
Monoamine Oxidase Inhibitors (MAOIs) & Tricyclic Antidepressants (TCAs) Potentiates the cardiovascular effects of formoterol, increasing the risk of hypertension or cardiac arrhythmias. Use with Extreme Caution
Diuretics (especially non-potassium-sparing), Xanthine Derivatives, Other Steroids May potentiate the beta2-agonist-associated risk of hypokalemia (low potassium levels) or adverse changes in heart rhythm (ECG changes). Use with Caution
Other Adrenergic Drugs (Sympathomimetics) May have additive effects, increasing the overall sympathetic stimulation and associated risks. Use with Caution

Important Interaction Constraints

Do Not Combine: Patients must not use Inuxair with other medicinal products containing a long-acting beta-agonist (LABA) for any reason, as this increases the risk of an overdose of the LABA component. The combination with strong CYP3A4 inhibitors should also be avoided unless clinically necessary, due to the increased systemic exposure to budesonide. In such cases, close monitoring for systemic corticosteroid effects is required.

Mechanism of Action

Inuxair is a fixed-dose combination containing beclometasone dipropionate (BDP) and formoterol fumarate (FF), delivered as an extra-fine aerosol primarily targeting the respiratory tract, including the small airways.

BDP, a corticosteroid, acts as an agonist at intracellular glucocorticoid receptors (GRs). Upon binding, the activated GR complex translocates to the nucleus, modifying gene transcription. This modification involves the transrepression of pro-inflammatory genes encoding cytokines, chemokines, and adhesion molecules, and the transactivation of genes encoding anti-inflammatory proteins, such as annexin-A1. These intracellular consequences modulate the systemic inflammatory response in the lung tissue.

FF acts as a selective long-acting agonist at beta2-adrenergic receptors located on airway smooth muscle cells. Receptor binding activates the adenylyl cyclase enzyme via G s protein coupling, increasing intracellular cyclic adenosine monophosphate (cAMP) levels. Elevated cAMP concentration mediates the phosphorylation of downstream protein kinases, leading to smooth muscle relaxation. This cellular action results in bronchodilation, increasing the radius of the pulmonary airways and modulating system-level airflow dynamics.

Dosage and Administration Information

How to Use Inuxair: Official Administration Guidelines

Inuxair (beclometasone dipropionate and formoterol fumarate dihydrate) is intended solely for oral inhalation as a long-term, continuous maintenance therapy for chronic obstructive airway diseases. The medicine is supplied as either a pressurised metered dose inhaler (pMDI) solution or an inhalation powder in devices like the NEXThaler. This inhaled route ensures the active ingredients are delivered directly to the respiratory tract.

Standard Dosing and Frequency

Usage patterns for the medicine require it to be inhaled twice daily—once in the morning and once in the evening—for consistent control. The dose is typically initiated at the lower end and should be titrated (adjusted) to the minimum level necessary to maintain effective stability. The maximum daily dose for maintenance therapy across both indications is restricted to four inhalations.

Usage Regimen Standard Adult Dose Strength Examples (Beclometasone/Formoterol per actuation)
Fixed Maintenance 1 to 2 inhalations twice daily 100 mu g/6 mu g or 200 mu g/6 mu g
Maximum Daily Total 4 inhalations total N/A

Special Administration Conditions

To ensure proper use and to minimize local residue, patients are directed to rinse their mouth or gargle with water, or brush their teeth, immediately after inhaling a dose. The pMDI device also requires a mandatory priming step before first use or after a period of non-use. While no dose adjustment is required for older adults, the higher strength (200 mu g/6 mu g) is generally not authorised for use in individuals under 18 years of age.

Recent Clinical Evidence

The information below summarizes the clinical research and evidence structure for the beclometasone and formoterol combination (Inuxair), relying on data from regulatory sources and peer-reviewed scientific studies. This summary focuses only on the scope and nature of the research, not on providing personal medical advice or instructions.

Research Evidence for Asthma Maintenance Treatment

Clinical research was studied for studies exploring long-term symptom patterns in persistent asthma. This evidence base primarily consists of randomized controlled trials (RCTs), which were applied in studies examining patient-reported experiences against other therapies, along with meta-analyses. Research was studied for changes in objective measures of lung function, such as FEV1. Studies also explored outcomes capturing phases of heightened symptom activity, focusing on the frequency and severity of asthma flare-ups. This research focused on adults and adolescents (typically 12 years and older) who had been previously receiving inhaled treatments but still had persistent symptoms.

Research Evidence for Chronic Obstructive Pulmonary Disease (COPD)

The evaluation of this combination in COPD is concentrated on studies examining the medicine in the context of long-term stability, particularly for patients with more functional limitations and a history of frequent, acute episodes. Long-term RCTs were central to this research. Research was evaluated in studies comparing the rate of COPD exacerbations between the combination and using the long-acting bronchodilator component alone. The research describes populations of adults who had compromised airflow and a documented history of acute episodes requiring extra medical attention.

Gaps and Areas of Uncertainty in the Research

One key limitation is that comparative evidence is lacking for a direct head-to-head comparison between this extra-fine formulation and all other non-extrafine ICS/LABA products available on the market, meaning comparative evidence is incomplete. Data for certain groups, such as children under 12 or populations not typically represented in large, controlled trials, remain insufficient. Research does not determine whether an individual will respond similarly to the group patterns described, and the results apply only to the populations studied.

Key Studies & References

  1. Effectiveness and safety of extrafine beclomethasone/formoterol in patients with asthma or COPD: a systematic review and meta-analysis of randomized controlled trials

Frequently Asked Questions (FAQ)

Common questions about Inuxair (FAQ)

Q: What are the storage requirements for Inuxair?

Official product information, based on regulatory labeling, states that Inuxair should typically be stored at room temperature.

Regulatory labeling indicates that the medication should be kept away from excessive moisture and direct heat, as improper storage may affect product quality. Specific storage details are always provided in the official patient information leaflet.


Q: Does taking Inuxair cause drowsiness or sleepiness?

Official regulatory documents indicate that Inuxair has been associated with certain side effects, such as dizziness or sleepiness, which are classified as effects on the central nervous system.

Because these effects may occur, regulatory documents typically advise exercising caution when performing activities that require alertness, such as driving or operating machinery. This information should be considered by all users.

How should Inuxair be stored and disposed of?

Inuxair must be stored according to regulatory requirements to ensure its stability and effectiveness.

Storage Conditions

The medicine must be kept out of the sight and reach of children.

After the foil pouch is first opened, the product must not be stored above 25°C and must be used within 6 months of that date. Before the pouch is opened, the product should be stored in the original package.

Handling of the pressurised canister requires care: it must not be exposed to temperatures higher than 50°C, and it should not be pierced or burned, even when empty.

Disposal

Expired or unused Inuxair must not be thrown away via wastewater or household waste. Disposal must occur according to local requirements and environmental protection measures, typically by returning the medicine to a pharmacist or an authorized waste disposal service.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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