Feboral: Uses, Dosage & Side Effects
A fixed-dose combination inhalation spray containing beclometasone dipropionate and formoterol fumarate for the maintenance treatment of asthma and COPD
Feboral is a prescription inhalation spray that combines two active substances – beclometasone dipropionate (100 micrograms), an inhaled corticosteroid (ICS) that reduces airway inflammation, and formoterol fumarate dihydrate (6 micrograms), a long-acting beta2-agonist (LABA) that relaxes the muscles surrounding the airways to improve breathing. This fixed-dose combination is used for the regular maintenance treatment of asthma in patients who require both anti-inflammatory therapy and long-acting bronchodilation, and for the symptomatic treatment of severe chronic obstructive pulmonary disease (COPD) in patients with a history of repeated exacerbations. The extrafine particle formulation ensures deep penetration into both large and small airways, optimizing drug delivery throughout the respiratory tract.
Quick Facts: Feboral
Key Takeaways
- Feboral is a fixed-dose combination inhalation spray containing beclometasone dipropionate (100 mcg) and formoterol fumarate dihydrate (6 mcg) per actuation, delivering both anti-inflammatory and bronchodilator effects in a single inhaler.
- It is indicated for the maintenance treatment of asthma (GINA Step 3 and above) when an ICS alone is insufficient, and for severe COPD (GOLD Group E) with a history of repeated exacerbations despite long-acting bronchodilator therapy.
- The extrafine particle formulation (mass median aerodynamic diameter <2 microns) achieves higher lung deposition than conventional inhalers, delivering medication effectively to both large and small airways.
- Common side effects include oral candidiasis (thrush), hoarseness, headache, and tremor – most are mild and manageable with proper inhaler technique and mouth rinsing after use.
- Feboral should not be used as a rescue inhaler for acute bronchospasm; patients must always have a separate short-acting beta2-agonist (e.g., salbutamol) available for emergency symptom relief.
What Is Feboral and What Is It Used For?
Feboral belongs to a class of medications known as fixed-dose inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) combinations. These medications represent a cornerstone of modern respiratory therapy and are recommended by major international guidelines, including the Global Initiative for Asthma (GINA) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD), for patients whose symptoms are not adequately controlled by a single-agent therapy. Feboral delivers two complementary active substances simultaneously through a single pressurized metered-dose inhaler (pMDI), simplifying treatment regimens and improving adherence.
The first active component, beclometasone dipropionate (100 micrograms per actuation), is an inhaled corticosteroid (ICS) that has been used in respiratory medicine for over four decades. Once inhaled and deposited in the airways, beclometasone dipropionate is converted by esterase enzymes to its active metabolite, beclometasone-17-monopropionate (B-17-MP), which has a high binding affinity for the glucocorticoid receptor. Activation of this receptor leads to the suppression of multiple inflammatory pathways: it inhibits the transcription of pro-inflammatory cytokines such as interleukin-4 (IL-4), IL-5, IL-13, and tumour necrosis factor-alpha (TNF-α); reduces the recruitment and activation of eosinophils, mast cells, and T-lymphocytes; decreases mucus hypersecretion; and restores the integrity of the airway epithelium. These anti-inflammatory effects reduce airway hyperresponsiveness, decrease the frequency and severity of asthma exacerbations, and help prevent the progressive airway remodelling that occurs with chronic, uncontrolled inflammation.
The second active component, formoterol fumarate dihydrate (6 micrograms per actuation), is a selective long-acting beta2-adrenergic agonist (LABA). Formoterol acts by binding to beta2-adrenergic receptors on airway smooth muscle cells, activating the intracellular enzyme adenylyl cyclase, which increases the production of cyclic adenosine monophosphate (cAMP). Elevated cAMP levels trigger a cascade of events that lead to relaxation of bronchial smooth muscle, resulting in bronchodilation and improved airflow. Formoterol has a rapid onset of action (within 1–3 minutes), distinguishing it from other LABAs such as salmeterol (onset 15–20 minutes), and provides sustained bronchodilation for at least 12 hours after a single inhalation. This rapid onset combined with long duration of action offers both prompt symptom relief and prolonged protection against bronchoconstriction.
A distinctive feature of Feboral is its extrafine particle formulation. Unlike conventional pressurized metered-dose inhalers, which produce particles with a mass median aerodynamic diameter (MMAD) of approximately 3–5 microns, Feboral generates particles with an MMAD of less than 2 microns. This extrafine formulation achieves significantly higher lung deposition (approximately 30–34% of the metered dose reaches the lungs, compared with 10–20% from conventional pMDIs) and enables effective drug delivery to both the large conducting airways and the small peripheral airways (those with a diameter of less than 2 mm). Research has increasingly recognized that small airway dysfunction plays a central role in the pathophysiology of both asthma and COPD, contributing to air trapping, hyperinflation, and overall symptom burden. By reaching these distal airways, Feboral addresses inflammation and bronchoconstriction throughout the entire bronchial tree.
Indications
Feboral is indicated for the following conditions:
- Asthma: Regular treatment of asthma where the use of a combination product (ICS plus LABA) is appropriate. This includes patients not adequately controlled with inhaled corticosteroids alone plus an as-needed short-acting beta2-agonist (corresponding to GINA Step 3 and above), or patients already adequately controlled on both an ICS and a LABA. According to GINA 2024 guidelines, combination ICS/LABA therapy is the preferred controller option at Steps 3–5 of asthma management, and low-dose ICS/formoterol combinations may also be used as both maintenance and reliever therapy (the MART approach) in appropriate patients.
- Chronic Obstructive Pulmonary Disease (COPD): Symptomatic treatment of patients with severe COPD (FEV1 <50% predicted normal) and a history of repeated exacerbations who have significant symptoms despite regular therapy with a long-acting bronchodilator alone. According to the GOLD 2024 report, ICS-containing combinations are recommended for patients with frequent exacerbations, particularly those with blood eosinophil counts ≥300 cells/μL or a concomitant diagnosis of asthma.
Beclometasone and formoterol exhibit molecular synergy beyond their individual effects. Corticosteroids upregulate the expression of beta2-adrenergic receptors on airway smooth muscle cells, enhancing the bronchodilator response to formoterol. Conversely, formoterol-induced activation of protein kinase A facilitates the nuclear translocation of the glucocorticoid receptor, augmenting the anti-inflammatory effects of beclometasone. This bidirectional enhancement means the combination delivers greater clinical benefit than either component used alone at the same doses.
What Should You Know Before Taking Feboral?
Contraindications
Feboral must not be used in patients with known hypersensitivity (allergy) to beclometasone dipropionate, formoterol fumarate dihydrate, or to any of the excipients in the formulation. The propellant used in Feboral is norflurane (HFA-134a), and while allergic reactions to this propellant are extremely rare, patients with a history of reactions to similar propellants should inform their doctor. The formulation also contains ethanol (a small amount as a co-solvent) and hydrochloric acid for pH adjustment.
There are no other absolute contraindications beyond hypersensitivity. However, Feboral is not indicated for the relief of acute bronchospasm or for the treatment of acute asthma attacks. It is a maintenance medication designed for regular, scheduled use, and patients must always have a separate short-acting bronchodilator (such as salbutamol or terbutaline) available for rapid relief of acute symptoms. Increasing reliance on rescue bronchodilator use is a warning sign of deteriorating disease control and should prompt a medical review.
Warnings and Precautions
Long-acting beta2-agonists (LABAs) should never be used as monotherapy for asthma without a concomitant inhaled corticosteroid, as LABA monotherapy has been associated with an increased risk of serious asthma-related events. Feboral contains both an ICS and a LABA in a fixed-dose combination, ensuring that the LABA component is always delivered with corticosteroid therapy. Do not discontinue the corticosteroid component separately.
Before starting Feboral, discuss the following conditions with your healthcare provider, as special caution or monitoring may be required:
- Cardiovascular disorders: Formoterol, like all beta2-agonists, can produce cardiovascular effects including increases in heart rate, blood pressure, and QTc interval prolongation. Patients with ischaemic heart disease, cardiac arrhythmias (particularly third-degree atrioventricular block), severe heart failure, hypertrophic obstructive cardiomyopathy, idiopathic subvalvular aortic stenosis, or uncontrolled hypertension should use Feboral with caution and under close medical supervision.
- Diabetes mellitus: Beta2-agonists may cause elevations in blood glucose levels through stimulation of glycogenolysis and gluconeogenesis. Patients with diabetes should monitor their blood glucose more frequently when starting Feboral, particularly during the initial weeks of treatment.
- Thyroid disorders: Formoterol should be used with caution in patients with thyrotoxicosis, as beta2-agonists may exacerbate symptoms of hyperthyroidism such as tremor, tachycardia, and heat intolerance.
- Hypokalaemia: Beta2-agonists can cause dose-related reductions in serum potassium levels through intracellular potassium shifting. This effect may be potentiated by concomitant use of xanthine derivatives (e.g., theophylline), systemic corticosteroids, or diuretics. Severe hypokalaemia can potentially lead to cardiac arrhythmias. Serum potassium levels should be monitored in patients at risk, particularly during acute severe asthma episodes.
- Phaeochromocytoma: Feboral should be administered with caution to patients with known or suspected phaeochromocytoma (a catecholamine-secreting adrenal tumour).
- Active or quiescent pulmonary tuberculosis, fungal or viral infections of the airways: Inhaled corticosteroids may mask or worsen these conditions. Patients with active pulmonary tuberculosis or untreated systemic fungal infections require appropriate antimicrobial treatment before starting Feboral.
Pregnancy and Breastfeeding
There are limited data on the use of Feboral specifically during pregnancy. However, the individual components have more extensive safety data. Beclometasone dipropionate has been widely used in pregnancy, and large observational studies have not demonstrated an increased risk of congenital malformations with inhaled corticosteroid use during pregnancy. International guidelines, including GINA 2024, strongly recommend that pregnant women with asthma continue their inhaled corticosteroid therapy, as poorly controlled asthma during pregnancy poses significant risks to both mother and fetus, including pre-eclampsia, gestational hypertension, premature birth, low birth weight, and perinatal mortality.
Animal reproduction studies with formoterol have shown some adverse effects at very high doses (reduced implantation rates, decreased early post-natal survival), but these doses are substantially higher than those achieved with inhaled administration in humans. Epidemiological data on formoterol use during pregnancy are limited but have not raised significant safety concerns when used at recommended inhaled doses.
As a precaution, Feboral should only be used during pregnancy when the expected benefit to the mother justifies the potential risk to the fetus. This is typically the case for women with moderate-to-severe asthma, where discontinuation of maintenance therapy would likely result in loss of disease control. Your doctor will help you weigh the risks and benefits and may adjust your treatment plan as needed throughout pregnancy.
It is not known whether beclometasone dipropionate or formoterol fumarate are excreted in human breast milk, although other corticosteroids have been detected in breast milk in small amounts. Given the low systemic bioavailability of inhaled beclometasone and formoterol at recommended doses, the risk to a breastfed infant is expected to be very low. The benefits of breastfeeding and the clinical need for the mother’s asthma or COPD treatment should be considered together in consultation with your healthcare provider.
Children and Adolescents
The use of Feboral in children depends on the specific product authorization in your country. Some formulations of beclometasone/formoterol are approved for adolescents aged 12 years and older for the treatment of asthma, but are generally not recommended for children under 12 due to insufficient data. Paediatric asthma management often involves different ICS doses and formulations, and the decision to use a combination ICS/LABA inhaler in younger patients should be made by a specialist following a careful assessment of disease severity and previous treatment response.
Driving and Operating Machinery
Feboral is not expected to affect your ability to drive or operate machinery. Neither beclometasone dipropionate nor formoterol fumarate at inhaled doses have been associated with clinically significant sedation, dizziness, or impairment of cognitive or motor function. However, if you experience any unusual symptoms such as dizziness, visual disturbances, or tremor that could affect your ability to drive safely, refrain from driving until the symptoms resolve and consult your doctor.
How Does Feboral Interact with Other Drugs?
Drug interactions with Feboral relate primarily to the pharmacological properties of its two active components. Understanding these interactions is important for safe and effective use of the medication, particularly in patients with multiple conditions who take several medicines concurrently. Below is a summary of the most clinically significant interactions, followed by a detailed table for reference.
Major Interactions
Beta-adrenergic blocking agents (beta-blockers): Non-selective beta-blockers such as propranolol, nadolol, and carvedilol may partially or completely block the bronchodilator effect of formoterol by antagonising beta2-adrenergic receptors on airway smooth muscle. In patients with asthma, beta-blocker use can also trigger acute bronchospasm, which may be severe and life-threatening. For this reason, non-selective beta-blockers are generally contraindicated in asthma and should be avoided in COPD patients taking Feboral whenever possible. Cardioselective beta-blockers (e.g., bisoprolol, metoprolol) may be used with caution under specialist supervision when there is a compelling cardiovascular indication, as they are less likely to antagonise beta2 receptors at therapeutic doses, though this selectivity is dose-dependent and not absolute. Importantly, this interaction also applies to beta-blocker eye drops (e.g., timolol) used for glaucoma, which can be absorbed systemically.
Strong CYP3A4 inhibitors: Beclometasone dipropionate is partially metabolised by the cytochrome P450 3A4 (CYP3A4) enzyme system. Co-administration with potent CYP3A4 inhibitors – such as ritonavir, cobicistat, itraconazole, ketoconazole, and certain macrolide antibiotics (e.g., clarithromycin) – can increase systemic exposure to beclometasone and its active metabolite, potentially leading to exaggerated corticosteroid side effects including adrenal suppression, Cushingoid features, reduced bone mineral density, and cataracts. If concomitant use with strong CYP3A4 inhibitors is necessary, patients should be monitored closely for systemic corticosteroid effects, and the lowest effective dose of the ICS should be used.
Other Important Interactions
QT-prolonging drugs: Formoterol, like other beta2-agonists, can prolong the QTc interval on electrocardiogram, particularly at doses higher than recommended. Concomitant use with other drugs known to prolong the QT interval – including certain antiarrhythmics (e.g., amiodarone, sotalol, disopyramide), tricyclic antidepressants (e.g., amitriptyline, nortriptyline), antihistamines (e.g., terfenadine, astemizole), macrolide antibiotics (e.g., erythromycin), fluoroquinolones (e.g., moxifloxacin), and certain antipsychotics (e.g., haloperidol, pimozide) – may increase the risk of ventricular arrhythmias and should be undertaken with caution.
Hypokalaemia-inducing agents: The hypokalaemic effect of formoterol may be potentiated by concomitant treatment with xanthine derivatives (e.g., theophylline, aminophylline), systemic corticosteroids (e.g., prednisolone, methylprednisolone), loop diuretics (e.g., furosemide), and thiazide diuretics (e.g., hydrochlorothiazide, bendroflumethiazide). Particular caution is advised in patients with acute severe asthma, as hypokalaemia in the context of hypoxia increases the risk of cardiac arrhythmias. Serum potassium levels should be monitored in patients receiving these combinations.
| Drug / Drug Class | Mechanism | Clinical Significance | Recommendation |
|---|---|---|---|
| Non-selective beta-blockers (propranolol, carvedilol) | Block beta2-receptors, antagonise bronchodilation | Major – risk of bronchospasm | Avoid in asthma; use with extreme caution in COPD |
| Strong CYP3A4 inhibitors (ritonavir, itraconazole, ketoconazole) | Increase systemic exposure to beclometasone | Major – risk of adrenal suppression | Monitor for systemic corticosteroid effects; consider dose reduction |
| QT-prolonging drugs (amiodarone, erythromycin, haloperidol) | Additive QTc prolongation with formoterol | Moderate – risk of arrhythmias | Use with caution; ECG monitoring if possible |
| Loop & thiazide diuretics (furosemide, hydrochlorothiazide) | Additive hypokalaemia with formoterol | Moderate – risk of arrhythmias | Monitor serum potassium; supplement if needed |
| Xanthine derivatives (theophylline, aminophylline) | Additive hypokalaemia and cardiac effects | Moderate | Monitor potassium and heart rate |
| Anticholinergic bronchodilators (tiotropium, ipratropium) | Complementary bronchodilation | Beneficial – additive effect | Can be used together; common in COPD triple therapy |
| Short-acting beta2-agonists (salbutamol, terbutaline) | Same receptor target as formoterol | Low – used as rescue therapy | Safe for rescue use; increasing need may indicate poor control |
Always inform your doctor, pharmacist, or respiratory nurse about all medications you are currently taking, including over-the-counter products, herbal supplements, and eye drops. Some beta-blocker eye drops used for glaucoma can interact with Feboral. Keep an up-to-date medication list and present it at every healthcare appointment.
What Is the Correct Dosage of Feboral?
Feboral should always be used exactly as prescribed by your doctor. Do not change the dose or stop using the inhaler without medical advice, even if you feel better. Abrupt discontinuation of inhaled corticosteroid therapy can lead to rapid loss of disease control and, in rare cases, adrenal crisis in patients who have been taking high doses for prolonged periods.
Adults (Asthma)
| Regimen | Dose per Inhalation | Puffs per Dose | Frequency | Max Daily Dose |
|---|---|---|---|---|
| Maintenance (low dose) | 100/6 mcg | 1 puff | Twice daily | 4 inhalations (400/24 mcg) |
| Maintenance (standard dose) | 100/6 mcg | 2 puffs | Twice daily | 4 inhalations (400/24 mcg) |
The starting dose depends on the severity of your asthma and your previous treatment. Patients stepping up from ICS monotherapy may begin with 1 inhalation twice daily, while those transferring from another ICS/LABA combination at equivalent doses may start with 2 inhalations twice daily. Your doctor will prescribe the lowest dose that maintains good symptom control and will reassess your treatment regularly (typically every 3 months) to determine whether step-down is appropriate.
Some clinical guidelines support the use of low-dose beclometasone/formoterol as a maintenance and reliever therapy (MART) approach, where the same inhaler is used both as a scheduled maintenance treatment and for relief of breakthrough symptoms. Under the MART regimen, patients take 1 inhalation twice daily as maintenance and may take additional inhalations as needed for symptom relief, up to a maximum of 8 inhalations per day (though the long-term daily maintenance dose should not exceed 4 inhalations). Your doctor will determine whether the MART approach is suitable for you based on your asthma phenotype and exacerbation history.
Adults (COPD)
COPD Maintenance Dose
2 inhalations twice daily (morning and evening), delivering a total daily dose of beclometasone dipropionate 400 mcg and formoterol fumarate 24 mcg. The dose should not be increased beyond this level. Regular review of COPD treatment should be performed at least every 12 months, and more frequently if exacerbations occur.
Children and Adolescents
The suitability of Feboral for adolescents (aged 12 years and over) depends on the specific product authorization. Where approved, the dose for adolescents with asthma is typically 1–2 inhalations twice daily, as for adults. Feboral is generally not recommended for children under 12 years of age due to limited data in this population. Paediatric asthma management should follow age-specific guidelines, and the choice of inhaler device and formulation should be made by a specialist experienced in treating childhood respiratory disease.
Elderly Patients
No dose adjustment is required for elderly patients. However, elderly patients may be more susceptible to certain adverse effects of both corticosteroids (such as osteoporosis and skin thinning) and beta2-agonists (such as tachycardia and tremor). Regular monitoring, including assessment of bone density in patients receiving long-term high-dose inhaled corticosteroids, is recommended. Inhaler technique should be regularly reviewed, as coordination difficulties are more common in older patients and can significantly reduce drug delivery to the lungs.
Missed Dose
If you miss a dose of Feboral, take it as soon as you remember. However, if it is nearly time for your next scheduled dose, skip the missed dose and continue with your regular schedule. Do not take a double dose to make up for a missed one. If you frequently forget doses, consider setting a daily alarm or using a medication reminder app to help maintain consistency. Consistent twice-daily use is important for optimal disease control.
Overdose
Overdose of the formoterol component may produce typical beta2-agonist effects including tremor, headache, palpitations, tachycardia, nausea, hypokalaemia, and hyperglycaemia. In severe cases, metabolic acidosis and cardiac arrhythmias may occur. Overdose of the beclometasone component is unlikely to cause acute clinical problems with a single overdose event, but prolonged administration of excessively high doses can lead to adrenal suppression. Treatment of overdose is supportive and symptomatic: cardioselective beta-blockers may be considered for severe beta2-agonist-related cardiac symptoms (used with extreme caution in patients with asthma), and potassium levels should be monitored and supplemented as necessary.
How to Use the Inhaler Correctly
Correct inhaler technique is essential for effective drug delivery. Poor technique is one of the most common reasons for inadequate symptom control in patients using inhaled medications. Follow these steps each time you use Feboral:
- Remove the mouthpiece cap and check the inhaler for foreign objects or damage.
- Shake the inhaler well (at least 5 seconds) to ensure thorough mixing of the formulation.
- Hold the inhaler upright with your thumb on the base and your index finger on the top of the canister.
- Breathe out gently (away from the inhaler) until your lungs feel comfortably empty. Do not force all the air out.
- Place the mouthpiece between your lips, sealing them around it without biting.
- Begin to breathe in slowly and deeply through your mouth, and simultaneously press down firmly on the canister to release one dose.
- Continue breathing in steadily and deeply for 4–5 seconds to draw the medication deep into your lungs.
- Remove the inhaler from your mouth and hold your breath for about 10 seconds, or as long as is comfortable, to allow the medication to settle in your airways.
- Breathe out slowly through your nose. If a second puff is prescribed, wait at least 30 seconds before repeating steps 2–8.
- Rinse your mouth with water and spit it out (do not swallow) to reduce the risk of oral candidiasis and hoarseness.
- Replace the mouthpiece cap after use.
If you find it difficult to coordinate pressing the canister and breathing in at the same time, your doctor may recommend using a spacer device (also called a valved holding chamber). A spacer attaches to the inhaler mouthpiece and creates a reservoir that holds the medication, allowing you to breathe it in at your own pace. Spacers also reduce the amount of medication deposited in the mouth and throat, which can further lower the risk of local side effects such as oral thrush.
What Are the Side Effects of Feboral?
Like all medicines, Feboral can cause side effects, although not everyone experiences them. Most side effects associated with ICS/LABA combination inhalers are predictable from the known pharmacology of the individual components and are dose-dependent. The side effects of the ICS component (beclometasone) relate primarily to local deposition in the oropharynx and, at higher doses, to systemic absorption. The side effects of the LABA component (formoterol) relate to beta2-adrenergic stimulation. The following frequency categories are based on data from clinical trials and post-marketing surveillance of beclometasone/formoterol combination products.
Common
- Oral candidiasis (thrush) – white patches in the mouth
- Hoarseness or voice changes (dysphonia)
- Throat irritation or pharyngitis
- Headache
- Tremor (usually of the hands)
- Palpitations (awareness of heartbeat)
Uncommon
- Influenza-like illness
- Fungal infections of the mouth, throat, or oesophagus
- Oral discomfort including mouth and tongue ulceration
- Dyspepsia (indigestion) or nausea
- Muscle cramps or myalgia
- Dizziness
- Agitation, anxiety, restlessness
- Sleep disturbances (insomnia)
- Tachycardia (fast heart rate)
- Prolongation of the QTc interval on ECG
- ECG changes (such as T-wave flattening, ST segment depression)
- Increased blood glucose levels
- Decreased serum potassium levels
- Skin reactions (rash, itching, urticaria)
Rare
- Paradoxical bronchospasm (worsening wheezing immediately after inhalation)
- Angioedema (swelling of face, lips, tongue, or throat)
- Hypersensitivity reactions including anaphylaxis
- Adrenal suppression (with prolonged high-dose use)
- Reduced bone mineral density (with prolonged high-dose use)
- Growth retardation in children (with prolonged high-dose use)
- Posterior subcapsular cataracts
- Glaucoma (increased intraocular pressure)
- Behavioural changes including hyperactivity and irritability (more common in children)
- Depression or psychomotor agitation
- Cardiac arrhythmias (atrial fibrillation, ventricular extrasystoles)
- Angina pectoris
- Peripheral oedema
Not Known
- Pneumonia (in COPD patients receiving inhaled corticosteroids)
- Cushing syndrome or Cushingoid features (very prolonged high-dose use)
- Blurred vision
Stop using Feboral and seek emergency medical care if you experience: sudden worsening of wheezing or breathing difficulty immediately after inhaling (paradoxical bronchospasm); severe allergic reaction with swelling of the face, lips, tongue, or throat; severe chest pain or irregular heartbeat; or signs of adrenal crisis (severe weakness, confusion, low blood pressure, collapse). Paradoxical bronchospasm should be treated immediately with a fast-acting rescue inhaler and Feboral should be discontinued pending medical review.
Reducing the Risk of Side Effects
Many of the common local side effects of Feboral can be minimized through simple practical measures:
- Mouth rinsing: Always rinse your mouth thoroughly with water (and spit it out) after each use to reduce the risk of oral candidiasis and hoarseness. Gargling briefly may also help clear medication from the throat.
- Spacer use: Using a spacer (valved holding chamber) can significantly reduce oropharyngeal deposition, lowering the incidence of thrush and dysphonia while maintaining effective lung delivery.
- Correct technique: Proper inhaler coordination ensures the medication reaches the lungs rather than being deposited predominantly in the mouth and throat. Ask your healthcare provider to check your technique at each visit.
- Lowest effective dose: Your doctor should prescribe the lowest dose that maintains good asthma or COPD control, reviewing your treatment regularly and stepping down if appropriate.
Pneumonia Risk in COPD
Clinical studies and meta-analyses have consistently demonstrated that the use of inhaled corticosteroids in COPD is associated with a small but statistically significant increase in the incidence of pneumonia. This is a class effect observed across all ICS products, not specific to Feboral. Patients with COPD who use Feboral should be alert to symptoms that might indicate pneumonia, such as fever, increased sputum production, purulent (yellow-green) sputum, increased breathlessness, or chest pain. The decision to use ICS-containing inhalers in COPD should be based on a careful risk-benefit assessment, considering the patient’s exacerbation history, eosinophil count, and overall clinical picture. International GOLD guidelines recommend ICS-containing combinations primarily for patients with frequent exacerbations and elevated blood eosinophil counts.
How Should You Store Feboral?
Proper storage of Feboral ensures the medication remains effective and safe throughout its shelf life. As a pressurized metered-dose inhaler containing a propellant gas (norflurane/HFA-134a), Feboral requires specific storage conditions to maintain the stability of the formulation and the integrity of the canister and valve system.
- Temperature: Store at a temperature below 25°C (77°F). Do not refrigerate or freeze, as extreme cold can affect the propellant pressure and valve function, leading to inconsistent dose delivery.
- Sunlight and heat: Protect from direct sunlight and heat sources. The pressurized canister must not be exposed to temperatures above 50°C (122°F), as this could cause the canister to rupture. Do not leave the inhaler in a car on a hot day or near radiators, ovens, or open flames.
- Canister integrity: Do not puncture or burn the canister, even when it appears empty, as residual propellant may still be under pressure.
- Children: Keep out of the sight and reach of children. Store in a secure location that children cannot access.
- Expiry date: Do not use Feboral after the expiry date printed on the label and packaging. After first use, the inhaler should be used within the timeframe specified in the patient information leaflet (typically 3–5 months, depending on the specific product).
- Disposal: Do not dispose of Feboral in household waste or wastewater. Return used or expired inhalers to your pharmacy for safe disposal. Pressurized metered-dose inhalers contain greenhouse gases, and proper disposal through pharmacy take-back programmes helps minimize environmental impact.
Unlike dry powder inhalers, pressurized metered-dose inhalers like Feboral do not have a built-in dose counter on all models. If your inhaler does not have a dose counter, keep track of the number of actuations used and replace the inhaler when the labelled number of doses has been reached. Using an inhaler beyond its rated number of actuations may result in receiving less medication than intended, as the canister content decreases. Some devices feature a dose counter integrated into the actuator that shows the remaining doses.
What Does Feboral Contain?
Active Ingredients
Feboral contains two active pharmaceutical ingredients per metered dose (ex-valve):
- Beclometasone dipropionate: 100 micrograms per actuation. Beclometasone dipropionate is a synthetic halogenated glucocorticosteroid with potent anti-inflammatory activity. It is a prodrug that is converted in the lungs to its active metabolite, beclometasone-17-monopropionate (B-17-MP), which has approximately 25–30 times the binding affinity for the glucocorticoid receptor compared to the parent compound. This local activation in the lung tissue contributes to the favorable systemic safety profile of inhaled beclometasone.
- Formoterol fumarate dihydrate: 6 micrograms per actuation. Formoterol is a potent, selective, long-acting beta2-adrenergic receptor agonist with a rapid onset of action. It is formulated as the fumarate dihydrate salt, which provides optimal stability in the pressurized metered-dose inhaler formulation. Formoterol has an intrinsic activity at the beta2-receptor that is substantially higher than salbutamol, contributing to its efficacy as a bronchodilator.
Inactive Ingredients (Excipients)
- Norflurane (HFA-134a): The propellant gas used to create the aerosol spray. HFA-134a (1,1,1,2-tetrafluoroethane) replaced older chlorofluorocarbon (CFC) propellants in metered-dose inhalers due to environmental concerns regarding ozone depletion. HFA-134a has a significantly lower global warming potential than some alternatives and is considered safe for inhalation.
- Ethanol (anhydrous): Used as a co-solvent to dissolve the active ingredients in the propellant, creating a solution-based formulation. This solution formulation is key to achieving the extrafine particle size that characterizes Feboral. The amount of ethanol per actuation is very small and is not considered clinically significant.
- Hydrochloric acid: Used in minute quantities for pH adjustment of the formulation to ensure stability and compatibility of the active ingredients.
Physical Description
Feboral is supplied as a pressurized inhalation solution in a small aluminum canister fitted with a metering valve, housed within a plastic actuator with a mouthpiece and protective cap. The solution is colourless to slightly yellow and does not contain any suspended particles. Each canister contains a specified number of actuations (typically 120 or 180 metered doses, depending on the specific product presentation). The extrafine aerosol produced on actuation consists of particles predominantly less than 2 microns in diameter, enabling deep lung penetration.
Frequently Asked Questions
Feboral is a maintenance (preventer) inhaler designed for regular, scheduled use to control underlying airway inflammation and provide sustained bronchodilation. It should be used every day, typically twice daily, regardless of whether you have symptoms. A rescue (reliever) inhaler, such as salbutamol (albuterol), is a short-acting bronchodilator used only when needed to provide rapid relief from acute symptoms such as sudden breathlessness, wheezing, or chest tightness. You must always carry a rescue inhaler alongside your Feboral treatment. If you find yourself using your rescue inhaler more than twice a week, it may indicate that your asthma is not well controlled, and you should contact your doctor for a treatment review.
The formoterol component of Feboral provides bronchodilation (opening of the airways) within 1–3 minutes of inhalation, with peak effect at approximately 15–30 minutes. This rapid onset is faster than some other LABAs such as salmeterol. However, the anti-inflammatory effect of the beclometasone component takes longer to develop: you may begin to notice improvement in overall symptom control within a few days, but the full anti-inflammatory benefit typically requires 1–2 weeks of consistent, regular use. It is important to continue using Feboral daily as prescribed, even if you feel well, as the corticosteroid component works by gradually reducing the underlying airway inflammation.
No, you should not stop using Feboral without consulting your doctor, even if you feel well. The reason your symptoms have improved is precisely because the medication is controlling the underlying airway inflammation and bronchoconstriction. Abruptly stopping an ICS/LABA inhaler can lead to a rapid worsening of symptoms, increased risk of exacerbations, and in rare cases, acute adrenal insufficiency (if high-dose corticosteroids have been used for prolonged periods). If your asthma has been well controlled for a sustained period (typically 3 months or longer), your doctor may consider a gradual step-down in treatment, reducing the dose in a controlled manner while monitoring your symptoms and lung function.
Oral candidiasis (thrush) – presenting as white patches on the tongue, inner cheeks, or roof of the mouth, sometimes with soreness or altered taste – is one of the most common side effects of inhaled corticosteroids. If you develop thrush, continue using Feboral and contact your doctor or pharmacist. Treatment typically involves an antifungal medication such as nystatin oral suspension or miconazole oral gel for 7–14 days. To prevent recurrence, ensure you rinse your mouth thoroughly with water (spit, do not swallow) and ideally gargle after every use of the inhaler. Using a spacer device can also substantially reduce the amount of medication deposited in the mouth, lowering the risk of thrush.
Yes, Feboral is safe to use during normal daily activities including exercise. In fact, regular use of an ICS/LABA combination inhaler helps to control the underlying airway inflammation and hyperresponsiveness that contribute to exercise-induced bronchoconstriction. Many patients find that their exercise tolerance improves with regular Feboral use. However, if you experience significant breathlessness during exercise despite regular maintenance therapy, discuss this with your doctor. You may benefit from using your short-acting rescue inhaler 15–20 minutes before exercise as additional protection. Staying physically active is an important part of managing asthma and COPD.
Yes, Feboral contains beclometasone dipropionate, which is a corticosteroid (often colloquially called a “steroid”). However, it is an inhaled corticosteroid, meaning it is delivered directly to the airways at a very low dose, with minimal absorption into the bloodstream. This is fundamentally different from oral (systemic) corticosteroids like prednisolone, which are associated with weight gain, fluid retention, and other significant side effects when used long-term. At the doses used in Feboral, systemic effects such as weight gain are extremely unlikely. The benefits of inhaled corticosteroids in controlling asthma inflammation far outweigh the minimal systemic risks at recommended doses.
References
- Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention. Updated 2024. Available at: GINA Reports.
- Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global Strategy for the Diagnosis, Management, and Prevention of COPD. 2024 Report. Available at: GOLD Reports.
- European Medicines Agency (EMA). Summary of Product Characteristics for beclometasone dipropionate / formoterol fumarate dihydrate pressurised inhalation solution. 2025.
- British Thoracic Society / Scottish Intercollegiate Guidelines Network (BTS/SIGN). British Guideline on the Management of Asthma. SIGN 158. Updated 2024.
- Papi A, Corradi M, Pigeon-Francisco C, et al. Beclometasone-formoterol as maintenance and reliever treatment in patients with asthma: a double-blind, randomised controlled trial. Lancet Respir Med. 2013;1(1):23–31. doi:10.1016/S2213-2600(13)70012-2.
- Singh D, Nicolini G, Bindi E, et al. Extrafine beclomethasone/formoterol compared to fluticasone/salmeterol combination therapy in COPD. BMC Pulm Med. 2014;14:43. doi:10.1186/1471-2466-14-43.
- Usmani OS, Barnes PJ. Assessing and treating small airways disease in asthma and chronic obstructive pulmonary disease. Ann Med. 2012;44(2):146–156. doi:10.3109/07853890.2011.585656.
- National Institute for Health and Care Excellence (NICE). Asthma: diagnosis, monitoring and chronic asthma management. NICE guideline NG80. Updated 2024.
- World Health Organization (WHO). Chronic Respiratory Diseases – Asthma. Available at: WHO Asthma Fact Sheet.
- British National Formulary (BNF). Beclometasone with formoterol. National Institute for Health and Care Excellence (NICE). 2025.
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