Beclofor (Beclometasone/Formoterol 100/6 mcg)

What Is Beclofor and What Is It Used For?

Beclofor is a fixed-dose combination pressurised metered-dose inhaler (pMDI) containing beclometasone dipropionate 100 micrograms and formoterol fumarate dihydrate 6 micrograms per actuation. It is indicated for the regular maintenance treatment of asthma and COPD where the use of a combination product is appropriate.

Beclofor belongs to a class of medications known as inhaled corticosteroid/long-acting beta-2 agonist (ICS/LABA) combinations. These combination inhalers have become a cornerstone of modern respiratory medicine because they address two fundamental aspects of chronic airway disease simultaneously: inflammation and bronchoconstriction. The Global Initiative for Asthma (GINA) recommends ICS/LABA combinations as a preferred treatment option for patients whose asthma is not adequately controlled with inhaled corticosteroids alone.

The corticosteroid component, beclometasone dipropionate (BDP), is a potent anti-inflammatory agent. When inhaled, it is converted to its active metabolite beclometasone-17-monopropionate (B-17-MP) in the lungs. This metabolite suppresses the inflammatory cascade that drives airway hyperresponsiveness, mucus hypersecretion, and structural remodelling in asthma and COPD. Beclometasone reduces the number and activation of eosinophils, mast cells, lymphocytes, macrophages, and neutrophils in the airways, thereby decreasing oedema, mucus production, and airway wall thickening over time.

The bronchodilator component, formoterol fumarate dihydrate, is a selective long-acting beta-2 adrenergic agonist (LABA). Formoterol works by stimulating beta-2 receptors on airway smooth muscle cells, activating the enzyme adenylyl cyclase and increasing intracellular cyclic AMP levels. This leads to relaxation of bronchial smooth muscle and dilation of the airways. Uniquely among LABAs, formoterol has a rapid onset of action (within 1–3 minutes) while providing sustained bronchodilation for approximately 12 hours, making it particularly suitable for twice-daily dosing regimens.

Beclofor is indicated for the treatment of asthma in adults and adolescents (typically 18 years and older) whose disease is not adequately controlled with inhaled corticosteroids and as-needed short-acting beta-2 agonists. It is also indicated for the symptomatic treatment of patients with severe COPD (FEV1 <50% predicted normal) who experience repeated exacerbations despite regular therapy with long-acting bronchodilators. For COPD patients, the addition of inhaled corticosteroids to long-acting bronchodilators has been shown in large clinical trials, including the TORCH and INSPIRE studies, to reduce the frequency and severity of exacerbations compared to bronchodilator monotherapy.

What Should You Know Before Taking Beclofor?

Before starting Beclofor, inform your doctor about all medical conditions, allergies, and current medications. Certain conditions such as active tuberculosis, untreated fungal infections, and severe cardiovascular disorders may require special consideration. Your healthcare provider will assess whether Beclofor is suitable for you.

Contraindications

Do not use Beclofor if you are allergic (hypersensitive) to beclometasone dipropionate, formoterol fumarate, or any of the other ingredients in this medication (including the propellant norflurane/HFA-134a). Hypersensitivity to these substances, while rare, can manifest as skin rash, urticaria, pruritus, angioedema, bronchospasm, or anaphylaxis. If you experience any of these symptoms after using Beclofor, stop using the inhaler and seek immediate medical attention.

Beclofor is generally contraindicated in patients with active or quiescent pulmonary tuberculosis unless they are receiving appropriate anti-tuberculosis treatment. The immunosuppressive effects of inhaled corticosteroids can potentially allow latent tuberculosis to reactivate. Similarly, patients with untreated systemic fungal, viral, or bacterial infections should not use Beclofor until the infection is adequately treated, as corticosteroids may impair the immune response and worsen the infection.

Patients with known severe cardiovascular disorders, including idiopathic hypertrophic subaortic stenosis, hypertrophic obstructive cardiomyopathy, severe heart failure, tachyarrhythmias, or recent myocardial infarction, should use Beclofor with extreme caution. The formoterol component can potentially increase heart rate and blood pressure, although clinically significant cardiovascular effects are uncommon at recommended inhaled doses. Your doctor will carefully weigh the potential benefits against the cardiovascular risks before prescribing Beclofor in these situations.

Warnings and Precautions

Talk to your doctor or pharmacist before using Beclofor if you have any of the following conditions or circumstances:

• Thyrotoxicosis (overactive thyroid): Formoterol may exacerbate thyrotoxic symptoms including tachycardia and tremor
• Phaeochromocytoma: Beta-2 agonists may precipitate a hypertensive crisis in patients with catecholamine-secreting tumours
• Diabetes mellitus: Formoterol may increase blood glucose levels; more frequent blood sugar monitoring may be needed when initiating treatment
• Hypokalaemia: Beta-2 agonists can cause a decrease in serum potassium; this effect may be potentiated by concurrent use of corticosteroids, theophylline, or diuretics
• Prolonged QT interval: Formoterol may prolong the QTc interval; use with caution in patients at risk for cardiac arrhythmias
• Osteoporosis: Long-term use of inhaled corticosteroids may reduce bone mineral density; patients at risk should be monitored and receive appropriate preventive therapy
• Glaucoma or cataracts: Systemic and topical corticosteroids may increase intraocular pressure or accelerate cataract formation; regular ophthalmological assessment is advisable for long-term users
• Adrenal suppression: Prolonged use of high-dose inhaled corticosteroids can suppress the hypothalamic-pituitary-adrenal (HPA) axis; patients transferring from oral corticosteroids to inhaled therapy require careful monitoring

If you experience worsening asthma symptoms or need your rescue inhaler more frequently while using Beclofor, this may indicate deteriorating disease control. Do not increase the dose of Beclofor beyond what is prescribed. Contact your doctor, who may need to add additional medication, adjust your treatment regimen, or investigate alternative diagnoses. Sudden and progressive deterioration of asthma control is potentially life-threatening and requires urgent medical assessment.

Patients should be advised that inhaled corticosteroids may cause local side effects in the oropharynx, including oral candidiasis (thrush) and dysphonia (hoarseness). Rinsing the mouth with water after each inhalation significantly reduces the incidence of these effects. If oral thrush develops, it can be treated with topical antifungal agents such as nystatin or miconazole without discontinuing Beclofor.

Pregnancy and Breastfeeding

If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor before using Beclofor. There is limited data on the use of Beclofor in pregnant women. However, the individual components have been more extensively studied. Beclometasone dipropionate has been used in pregnant women for decades, and inhaled corticosteroids are generally considered the preferred controller therapy for asthma during pregnancy according to GINA guidelines and the National Asthma Education and Prevention Program (NAEPP). Uncontrolled asthma during pregnancy carries greater risks to both mother and foetus (including pre-eclampsia, preterm birth, and low birth weight) than the use of inhaled corticosteroids.

Animal studies with formoterol have shown reproductive toxicity at very high systemic exposure levels. However, there are no adequate and well-controlled studies of formoterol in pregnant women. The potential benefit of maintaining asthma control during pregnancy should be weighed against the theoretical risks of LABA exposure. In clinical practice, many respiratory physicians continue ICS/LABA combinations during pregnancy when they are needed to maintain disease control, as the risks of uncontrolled asthma generally outweigh the potential medication risks.

It is not known whether beclometasone or formoterol are excreted in human breast milk. Given the low systemic bioavailability of both components when administered by inhalation, the amount likely to reach breast milk is expected to be very small. Your doctor will help you decide whether the benefits of breastfeeding and the benefits of Beclofor therapy outweigh any potential risks to the nursing infant.

How Does Beclofor Interact with Other Drugs?

Beclofor may interact with beta-blockers, strong CYP3A4 inhibitors (such as ketoconazole and ritonavir), QT-prolonging medications, other sympathomimetic agents, and potassium-lowering drugs. Always inform your doctor about all medicines you are currently taking to avoid potentially harmful drug interactions.

Drug interactions with Beclofor can be broadly categorised into those affecting the corticosteroid component (beclometasone) and those affecting the bronchodilator component (formoterol). Understanding these interactions is essential for safe and effective use of the medication. The following sections detail the most clinically significant interactions, although this list is not exhaustive.

Beclometasone dipropionate is metabolised primarily by esterases to its active metabolite B-17-MP, rather than by cytochrome P450 enzymes. However, at high systemic exposures, some metabolism via CYP3A4 may occur. Strong CYP3A4 inhibitors, such as ritonavir, ketoconazole, itraconazole, and cobicistat, may increase systemic exposure to beclometasone, potentially amplifying corticosteroid-related side effects including adrenal suppression, Cushing-like features, and osteoporosis. While the clinical significance of this interaction is generally lower for inhaled beclometasone than for inhaled fluticasone (which is more extensively metabolised by CYP3A4), caution is still warranted.

Formoterol is metabolised mainly by direct glucuronidation and O-demethylation via CYP2D6 and CYP2C enzymes. Clinically significant pharmacokinetic interactions with formoterol are uncommon. However, pharmacodynamic interactions are more relevant. Concomitant use of other sympathomimetic agents (e.g., other beta-2 agonists, pseudoephedrine, phenylephrine) may enhance the cardiovascular effects of formoterol and should be used with caution.

Major Interactions

The table above is not exhaustive. Many other medications may potentially interact with Beclofor. Always carry a complete list of all your medications (including over-the-counter products and dietary supplements) and share it with every healthcare provider you visit. This helps prevent potentially harmful drug interactions and ensures you receive the safest and most effective treatment possible.

What Is the Correct Dosage of Beclofor?

The usual adult dose of Beclofor for asthma is 1–2 inhalations twice daily. For COPD, the recommended dose is 2 inhalations twice daily. The maximum recommended dose is 2 inhalations twice daily (total daily dose: beclometasone 400 mcg + formoterol 24 mcg). Dosage should be individualised and regularly reviewed by your doctor.

The dose of Beclofor should be individualised based on disease severity, previous therapy, and the patient's response to treatment. The aim of treatment is to achieve and maintain asthma control or reduce COPD exacerbations using the lowest effective dose. Once stable control is achieved, your doctor should periodically review your treatment and attempt to step down the dose to the minimum that maintains adequate disease control.

Adults (Asthma)

Adults (COPD)

Elderly Patients

No dose adjustment is required in elderly patients. However, elderly patients may be more susceptible to certain adverse effects of both inhaled corticosteroids (such as osteoporosis and skin thinning) and beta-2 agonists (such as tachycardia and tremor). Renal and hepatic function should be considered, and regular monitoring for side effects is advisable. Elderly patients may also benefit from using a spacer device to improve drug delivery and reduce oropharyngeal deposition.

Children and Adolescents

The safety and efficacy of Beclofor in children under 18 years of age have not been established for all formulations. The use of combination ICS/LABA inhalers in paediatric patients should follow GINA guidelines and be under the supervision of a specialist in paediatric respiratory medicine. Some ICS/LABA combinations are approved for children aged 12 and above; however, the specific age indication depends on the formulation and regulatory jurisdiction. Always consult a paediatrician or respiratory specialist before prescribing Beclofor to patients under 18.

Correct Inhaler Technique

Correct inhaler technique is critical for effective drug delivery. Studies show that up to 70–80% of patients use their pressurised metered-dose inhalers (pMDIs) incorrectly, significantly reducing the amount of medication reaching the lower airways. Follow these steps for proper Beclofor use:

1. Shake the inhaler well (3–4 seconds) before each use to ensure uniform drug suspension
2. Remove the mouthpiece cap and inspect the mouthpiece for foreign objects
3. Breathe out gently and completely (away from the inhaler, not into it)
4. Hold the inhaler upright and place the mouthpiece between your teeth, sealing your lips around it
5. Begin to breathe in slowly and deeply through your mouth, and press the canister down firmly once to release one dose
6. Continue to breathe in slowly and deeply (the inhalation should take about 3–5 seconds)
7. Remove the inhaler from your mouth and hold your breath for about 10 seconds (or as long as comfortable)
8. Breathe out slowly through your nose
9. If a second inhalation is prescribed, wait at least 30 seconds before repeating steps 1–8
10. Rinse your mouth with water and spit it out after use

If you have difficulty coordinating the button press with inhalation, a spacer device (also known as a valved holding chamber) can be used with Beclofor. A spacer creates a reservoir that holds the medication, allowing you to inhale it over several breaths without needing perfect timing. Spacers also reduce oropharyngeal deposition, decreasing the risk of oral thrush and hoarseness. Ask your pharmacist or doctor about compatible spacer devices.

Missed Dose

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. Consistent twice-daily use is important for maintaining optimal airway control. If you frequently forget doses, consider setting a daily alarm or associating inhaler use with a regular daily routine (such as brushing your teeth).

Overdose

In the event of an overdose, symptoms are primarily related to the formoterol component and may include tremor, headache, palpitations, tachycardia, nausea, and hypokalaemia. In severe cases, metabolic acidosis, hyperglycaemia, and cardiac arrhythmias may occur. Excessive doses of inhaled beclometasone taken over a prolonged period may lead to suppression of the hypothalamic-pituitary-adrenal (HPA) axis, adrenal insufficiency, and reduced bone mineral density.

There is no specific antidote for Beclofor overdose. Treatment is supportive and symptomatic. Cardioselective beta-blockers may be considered for the management of severe formoterol-related cardiovascular effects, but should be used with extreme caution in patients with a history of bronchospasm. Serum potassium levels should be monitored, and electrolyte replacement given as necessary. Contact your local poison control centre or seek emergency medical attention if you suspect an overdose.

What Are the Side Effects of Beclofor?

Like all medicines, Beclofor can cause side effects, although not everybody gets them. The most common side effects are oral thrush (candidiasis), hoarseness, headache, and tremor. Most side effects are mild and can be managed by rinsing the mouth after use and correct inhaler technique. Serious side effects are rare but require immediate medical attention.

The side effects of Beclofor reflect the pharmacological profiles of its two active ingredients. The inhaled corticosteroid component (beclometasone) is mainly associated with local oropharyngeal effects, while systemic effects are uncommon at recommended doses but may occur with long-term high-dose use. The beta-2 agonist component (formoterol) is primarily associated with sympathomimetic effects such as tremor and palpitations.

Clinical trials and post-marketing surveillance data for beclometasone/formoterol combination inhalers have established the following side effect profile. The frequency categories are defined according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), and rare (<1/1,000).

If you experience paradoxical bronchospasm (a sudden increase in wheezing, chest tightness, and shortness of breath immediately after using the inhaler), stop using Beclofor, use your rescue inhaler, and contact your doctor. Paradoxical bronchospasm is a rare but potentially serious adverse reaction that requires immediate assessment. The cause may be related to the propellant, excipients, or the drug itself. Your doctor may need to switch you to an alternative inhaler device or formulation.

Long-term use of inhaled corticosteroids at high doses can lead to systemic effects including adrenal suppression, decreased bone mineral density, and increased susceptibility to infections. Regular monitoring (including periodic bone density scans for patients at risk of osteoporosis, regular eye examinations, and monitoring of growth in children and adolescents) is recommended for patients on long-term ICS therapy. These systemic effects are dose-dependent and are much less common with inhaled corticosteroids than with oral corticosteroids.

How Should You Store Beclofor?

Store Beclofor at room temperature below 25°C (77°F), away from direct heat, sunlight, and frost. Do not freeze. The pressurised canister contains a flammable propellant – do not expose to temperatures above 50°C or puncture the canister. Keep out of reach of children.

Proper storage of Beclofor is essential to ensure the medication remains effective and safe throughout its shelf life. The pressurised metered-dose inhaler should be stored at room temperature, not exceeding 25°C (77°F). Avoid exposure to direct sunlight, radiators, or other sources of heat. Do not refrigerate or freeze the inhaler, as extreme temperatures can affect the performance of the pressure vessel and the consistency of the drug formulation.

The canister contains a pressurised liquid propellant (norflurane, also known as HFA-134a). As with all pressurised containers, the canister should not be punctured, broken, or incinerated, even when apparently empty. Do not expose the canister to temperatures exceeding 50°C (122°F), as excessive heat may cause the canister to burst. The aerosol is flammable and should be kept away from open flames and sources of ignition.

Do not use Beclofor after the expiry date printed on the canister and outer packaging. The expiry date refers to the last day of that month. If your pharmacist has noted a date to discard the inhaler after first opening (some formulations have a shorter in-use shelf life), follow this date even if it is earlier than the printed expiry date. Do not dispose of medications via wastewater or household waste – ask your pharmacist about proper disposal methods to help protect the environment.

Keep Beclofor and all medicines out of the sight and reach of children. Store the inhaler with the mouthpiece cap on to protect it from dust and debris. If the inhaler has not been used for more than 7 days (or for the first time), prime it by releasing 1–2 sprays into the air away from the face before use, to ensure the valve mechanism delivers a full dose.

What Does Beclofor Contain?

Each actuation of Beclofor delivers 100 micrograms of beclometasone dipropionate and 6 micrograms of formoterol fumarate dihydrate. The excipients include ethanol and the propellant norflurane (HFA-134a). Beclofor is a solution-based pressurised metered-dose inhaler.

The active substances in Beclofor are beclometasone dipropionate (100 micrograms per metered dose) and formoterol fumarate dihydrate (6 micrograms per metered dose). These represent the ex-valve doses (the amount released from the valve); the ex-actuator doses (the amount delivered from the mouthpiece that is available for inhalation by the patient) are slightly lower due to losses within the device.

The other ingredients (excipients) include ethanol (anhydrous) and norflurane (HFA-134a) as propellant. Unlike older chlorofluorocarbon (CFC) propellants, norflurane is a hydrofluoroalkane that does not deplete the ozone layer. The formulation is a solution formulation, meaning the active ingredients are dissolved in the propellant/ethanol mixture rather than being suspended as particles. Solution formulations tend to produce a finer aerosol with smaller particle size, which may improve lung deposition and reduce oropharyngeal impaction compared to traditional suspension-based pMDIs.

Beclofor does not contain any lactose, sucrose, or other sugars. It does not contain gluten. Patients with known hypersensitivity to any of the listed excipients should inform their doctor before using this inhaler. The ethanol content per actuation is very small and is not expected to cause any clinical effects.