Quick Facts

• Regular Treatment: Used for the maintenance treatment of asthma and Chronic Obstructive Pulmonary Disease (COPD) in adults.
• Symptom Management: Supports the management of symptoms associated with these conditions, such as shortness of breath, cough, and wheezing.
• Combination Therapy: Appropriate for adult patients whose asthma is not adequately controlled by other specific inhaled medications, or for those already maintained on a combination regimen.

Fostair (beclometasone/formoterol) is indicated for the regular, long-term therapeutic management of certain respiratory conditions in adult patients. Its primary use is in the maintenance treatment of asthma, specifically in individuals whose disease control requires a combination approach of an inhaled corticosteroid and a long-acting bronchodilator. This combination helps to address both underlying inflammation and airway constriction.

Fostair is also used for the symptomatic treatment of severe Chronic Obstructive Pulmonary Disease (COPD) in patients who continue to experience significant symptoms and have a history of repeated exacerbations despite receiving standard bronchodilator therapy. The medication may support the reduction of symptoms such as wheezing, cough, and feelings of breathlessness related to these chronic conditions. The initiation of Fostair for asthma management may be considered when the condition is not adequately controlled by an inhaled corticosteroid and an as-needed rapid-acting bronchodilator.

Fostair's official regulatory labeling defines who is eligible for use, focusing primarily on age, clinical state, and pre-existing health conditions. Use is strictly limited to adults aged 18 years and above for maintenance therapy. It is not recommended or contraindicated in children and adolescents under 18 due to insufficient safety and efficacy data. The medicine is contraindicated (absolutely must not be used) in patients with known hypersensitivity to the active ingredients (beclometasone or formoterol) or any excipients. Furthermore, Fostair is explicitly forbidden for the primary treatment of an acute asthma attack or a sudden, severe worsening of COPD, as it is designed for chronic, long-term maintenance. Use is also not recommended during pregnancy and lactation unless the potential benefits clearly outweigh the unknown risks. Additionally, caution is required for patients with certain comorbidities, including severe cardiovascular disorders (e.g., cardiac arrhythmias, severe heart failure), diabetes mellitus, and specific infectious conditions like active or quiescent pulmonary tuberculosis, as these conditions may require careful monitoring during therapy. There are no specific data available for use in patients with severe hepatic or renal impairment, requiring use in these populations to be approached with caution.

Interactions with other medicines and products

The official regulatory profile for Fostair (Beclometasone/Formoterol) structures its interactions based on the effects of its two active components, leading to pharmacokinetic (PK) and pharmacodynamic (PD) constraints.

Contraindicated and High-Risk Combinations

The co-administration of Fostair with other Long-Acting Beta-2-Agonists (LABAs) is restricted in prescribing information due to the potential for excessive sympathetic stimulation and related severe cardiovascular effects. Extreme caution is also advised for co-treatment with Monoamine Oxidase Inhibitors (MAOIs), Tricyclic Antidepressants (TCAs), and other drugs that prolong the QTc interval, as these may potentiate the cardiovascular action of the Formoterol component.

Interactions Affecting Drug Levels

Fostair's Beclometasone component is cleared by the CYP3A4 enzyme system. Co-administration with potent CYP3A4 Inhibitors, such as Ritonavir or Ketoconazole, is expected to increase the systemic exposure of Beclometasone. Regulatory documents advise avoiding this co-treatment or separating administrations by the longest possible time interval.

Other Pharmacodynamic Interactions

The efficacy of the Formoterol component may be reduced by the pharmacodynamic antagonism of Beta-blockers. Furthermore, co-treatment with Non-Potassium Sparing Diuretics, Xanthine Derivatives, or other steroids can potentiate the risk of hypokalemia and associated ECG changes.

Fostair's mechanism of action involves the distinct and coordinated biological functions of its two active components, formoterol and beclometasone.

Formoterol functions as a highly selective agonist at the beta2-Adrenergic Receptor (beta2-AR), predominantly on airway smooth muscle cells. Binding to this receptor initiates an intracellular signaling cascade that increases cyclic adenosine monophosphate (cAMP), which subsequently modulates the activity of the contractile machinery. This action is exerted within autonomic signaling pathways, resulting in the immediate and sustained relaxation of the muscle bands around the bronchial tubes and the subsequent increase in the functional diameter of the airways.

Beclometasone mediates its anti-inflammatory mechanism by targeting the intracellular Glucocorticoid Receptor (GR). The activated beclometasone/GR complex translocates to the cell nucleus where it engages in Transrepression, physically inhibiting transcription factors like NF-kappaB that drive the production of pro-inflammatory mediators. This gene-driven effect serves to modulate excessive activity within chronic inflammatory processes, leading to a gradual reduction in airway wall edema and hyperresponsiveness. Furthermore, the corticosteroid component upregulates the gene expression of the beta2-AR, protecting the receptor from agonist-induced desensitization, which supports the maintenance of functional responsiveness.

Fostair is administered solely by the oral inhalation route using a pressurised metered dose inhaler (pMDI) or dry powder inhaler (DPI) device to deliver the dose into the lungs.

Official Dosing Rules

The maximum daily maintenance dose is 4 inhalations. When using the Maintenance and Reliever (MART) regimen, the total maximum daily dose is 8 inhalations (including maintenance and as-needed doses). Fostair is generally not recommended for patients under 18 years of age.

Procedural and Administration Conditions

1. Preparation: Before first use, or if the inhaler has not been used for 14 days or more, one actuation must be released into the air to prime the device.
2. Technique: For pMDI devices, patients must inhale slowly and deeply immediately after pressing the canister. If taking more than one inhalation, wait approximately 30 seconds before repeating the process.
3. Oral Hygiene: To minimize the risk of oral fungal infection, the mouth must be rinsed or gargled with water or the teeth must be brushed immediately after inhalation and the water spat out.
4. Missed Dose: If a dose is missed, it should be taken as soon as possible, but the patient must not take the missed dose at the same time as the next scheduled dose; return to the regular schedule thereafter. Treatment must not be stopped abruptly.

Recent Clinical Evidence Overview

Fostair is a combination inhaler containing beclometasone dipropionate (an inhaled corticosteroid) and formoterol fumarate dihydrate (a long-acting beta2-agonist), formulated as an extra-fine particle solution. The small particle size is a key feature, as research has explored whether it facilitates more uniform distribution of the medication to both the central and peripheral airways.

Clinical Trial Findings

Clinical research has focused on the use of this combination for the regular maintenance treatment of both asthma and Chronic Obstructive Pulmonary Disease (COPD) in adults. Key areas of investigation have included efficacy in reducing exacerbations and improving lung function.

Asthma

Studies have assessed the use of Fostair for Maintenance and Reliever Therapy (MART) in patients with moderate to severe asthma. One significant 48-week randomized controlled trial reported that using the beclometasone-formoterol combination for both maintenance and as-needed relief was associated with an increase in the time to the first severe asthma exacerbation compared to a regimen using the combination for maintenance only plus a separate short-acting reliever. This difference suggested a reduced risk of exacerbation in the MART group.

COPD

Real-world effectiveness studies have been conducted comparing the extra-fine combination to other inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) combinations in patients with COPD. These historical cohort studies investigated the effect of initiating treatment with Fostair on the subsequent rate of moderate to severe COPD exacerbations over a one-year period. Findings indicated that the extra-fine formulation was non-inferior (comparable) to certain other commonly prescribed non-extrafine ICS/LABA combination inhalers in preventing these exacerbations.

Key Studies & References

1. Public Assessment Report National Procedure Luforbec 100/6 micrograms per actuation pressurised inhalation solution (beclometasone dipropionate and formoterol fumarate dihydrate)

Common questions about Fostair (FAQ)

Q: What are the symptoms of a serious allergic reaction to Fostair?

Regulatory labels for Fostair warn of rare but serious hypersensitivity reactions. These reactions may include severe symptoms such as swelling of the skin and mucous membranes (angioedema). If a serious allergic reaction is suspected, immediate medical attention should be sought.

Q: How long does it take for Fostair to start working to improve my breathing overall?

Fostair has two components: the Formoterol (bronchodilator) works very quickly to open your airways. However, the Beclometasone (anti-inflammatory) component takes longer to reduce swelling and improve underlying airway condition. Therefore, the full, sustained clinical benefit to breathing may take several weeks to fully develop.

Q: I'm on a blood pressure medication (a Beta-blocker); can I still take Fostair?

Official product information states that non-selective Beta-blockers should generally be avoided while taking Fostair. This is because they can counteract and reduce the effect of the Formoterol component. If a Beta-blocker is being considered, consulting with a healthcare professional about the co-treatment is recommended.

Q: What is paradoxical bronchospasm, and what should I do if it happens?

Paradoxical bronchospasm is a serious but rare adverse reaction characterized by a sudden and unexpected worsening of breathing immediately after inhalation. The medication's product label indicates that if this occurs, the medicine should be immediately discontinued, and urgent medical help for breathing should be sought.

Q: Does Fostair contain steroids, and if so, how is it different from oral steroids?

Yes, Fostair contains Beclometasone, which is an inhaled corticosteroid (ICS). ICSs are intended to deliver the medicine primarily to the airways to manage inflammation, which generally results in a lower systemic exposure compared to oral steroids, which affect the body systemically.

Q: How will I know if my Fostair inhaler is running low or empty?

Official instructions for use indicate that your Fostair inhaler is typically fitted with a dose counter on the back of the device. This counter tracks the number of remaining actuations (doses). The device should be discarded and replaced when the counter reaches '0' to ensure continued dosage accuracy.

Q: What is the difference between the Maintenance Only regimen and the MART regimen?

The Maintenance Only regimen uses Fostair for regular, twice-daily maintenance care only, requiring a separate short-acting inhaler for symptom relief. In contrast, the Maintenance and Reliever Therapy (MART) regimen uses the single Fostair inhaler for both regular maintenance and for as-needed symptom relief.

Q: Is it safe to drive or operate machinery while taking Fostair?

According to official product leaflets, Fostair is unlikely to affect the ability to drive or use machines. However, side effects such as dizziness or trembling are recognized as possible. If these effects are experienced, it is recognized that the ability to safely drive or operate equipment may be temporarily impaired.

Q: Can Fostair make me gain weight or affect my appetite?

Changes in weight or appetite are generally not listed as common or uncommon side effects of Fostair. However, the very rare, long-term risks associated with the corticosteroid component may include systemic effects, such as adrenal suppression, which can sometimes be associated with weight gain.

Storage and Disposal Instructions for Fostair

Fostair (beclometasone/formoterol) must be kept out of the sight and reach of children.

Storage Requirements

Disposal

Unused or expired Fostair must not be disposed of via waste water or household waste. All product must be returned to a pharmacist for proper disposal.