BiResp Spiromax: Uses, Dosage & Side Effects
A combination inhaler containing budesonide (corticosteroid) and formoterol (long-acting bronchodilator) for the maintenance treatment of asthma and COPD
BiResp Spiromax is a prescription combination inhaler containing budesonide (160 micrograms), an inhaled corticosteroid (ICS) that reduces airway inflammation, and formoterol fumarate dihydrate (4.5 micrograms), a long-acting beta2-adrenergic agonist (LABA) that relaxes bronchial smooth muscle and opens the airways. It is indicated for the regular maintenance treatment of asthma in adults aged 18 years and older where both an inhaled corticosteroid and a long-acting bronchodilator are appropriate, and for the symptomatic treatment of chronic obstructive pulmonary disease (COPD) in adults with a post-bronchodilator FEV1 less than 70% predicted and a history of frequent exacerbations. BiResp Spiromax uses the Spiromax breath-actuated dry powder inhaler device, designed for intuitive use and consistent dose delivery.
Quick Facts: BiResp Spiromax
Key Takeaways
- BiResp Spiromax combines budesonide (an anti-inflammatory corticosteroid) with formoterol (a fast-onset, long-acting bronchodilator) in a single breath-actuated dry powder inhaler for the maintenance treatment of asthma and COPD.
- The Spiromax device is designed for intuitive use with a simple open-inhale-close technique, making it easier for patients to achieve correct inhaler technique compared to some other dry powder inhalers.
- Formoterol provides rapid bronchodilation within 1–3 minutes of inhalation, while budesonide delivers sustained anti-inflammatory effects with regular use, reducing the frequency and severity of exacerbations.
- Common side effects include oral thrush (candidiasis), headache, and tremor; rinsing the mouth with water after each inhalation significantly reduces the risk of oral fungal infections.
- BiResp Spiromax must be used regularly every day as prescribed, even when asymptomatic, and is not intended as the sole treatment for acute asthma attacks — a separate rapid-acting reliever inhaler should be available at all times.
What Is BiResp Spiromax and What Is It Used For?
BiResp Spiromax contains two active substances that work together to manage chronic respiratory conditions: budesonide and formoterol fumarate dihydrate. These two drugs belong to different pharmacological classes and have complementary mechanisms of action, which is why they are combined in a single inhaler to provide both anti-inflammatory and bronchodilatory effects simultaneously.
Budesonide is a glucocorticosteroid (corticosteroid) that acts locally in the airways to reduce inflammation. When inhaled regularly, budesonide suppresses the inflammatory cascade that underlies asthma and COPD. It works by binding to intracellular glucocorticoid receptors, which then translocate to the cell nucleus and modulate the transcription of numerous genes involved in the inflammatory response. This leads to decreased production of inflammatory mediators such as cytokines, chemokines, and leukotrienes, reduced recruitment and activation of inflammatory cells (eosinophils, mast cells, T lymphocytes, macrophages, and neutrophils), decreased mucus secretion, and reduced airway hyperresponsiveness. The anti-inflammatory effects of budesonide are not immediately apparent; regular daily use over days to weeks is required to achieve and maintain optimal asthma and COPD control. This is why BiResp Spiromax must be used consistently, even during periods when the patient feels well.
Formoterol fumarate dihydrate is a selective long-acting beta2-adrenergic agonist (LABA). It works by stimulating beta2-adrenergic receptors in the smooth muscle of the airways, leading to activation of adenylyl cyclase, increased intracellular cyclic adenosine monophosphate (cAMP) levels, and subsequent relaxation of bronchial smooth muscle. This results in bronchodilation — a widening of the airways that allows more air to flow in and out of the lungs. A distinguishing feature of formoterol compared to other LABAs (such as salmeterol) is its rapid onset of action. Formoterol begins to work within 1–3 minutes of inhalation, providing prompt symptom relief, while its bronchodilatory effect lasts for at least 12 hours. This dual characteristic of fast onset and long duration makes formoterol particularly suitable for combination with an ICS in a maintenance inhaler.
The combination of these two active substances in BiResp Spiromax provides complementary benefits that are greater than either component alone. The ICS component (budesonide) addresses the underlying inflammatory process, reducing airway swelling, mucus production, and hyperreactivity. The LABA component (formoterol) provides sustained bronchodilation, keeping the airways open and making breathing easier. International guidelines, including the Global Initiative for Asthma (GINA) 2024 report and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2024 report, recommend ICS/LABA combination therapy as a cornerstone of treatment for patients whose symptoms are not adequately controlled by an ICS alone.
Indications
BiResp Spiromax is indicated for the following conditions:
- Asthma: Regular treatment of asthma in adults (18 years and older) where the use of a combination product (inhaled corticosteroid and long-acting beta2-agonist) is appropriate. This includes patients who are not adequately controlled with inhaled corticosteroids and as-needed short-acting beta2-agonists, or patients who are already adequately controlled on both an inhaled corticosteroid and a long-acting beta2-agonist.
- Chronic Obstructive Pulmonary Disease (COPD): Symptomatic treatment of patients with severe COPD (post-bronchodilator FEV1 <70% of predicted normal) and a history of repeated exacerbations despite optimal therapy with long-acting bronchodilators. In COPD, the ICS component helps reduce the frequency of exacerbations, while the LABA provides sustained bronchodilation and symptom relief.
The Spiromax Device
BiResp Spiromax is delivered via the Spiromax dry powder inhaler, a multi-dose, breath-actuated device. The Spiromax inhaler was designed with a focus on intuitive use. Its key features include a simple three-step operation (open the cap, inhale, close the cap), a dose counter that counts down from 60 doses, and a built-in mechanism that loads the dose automatically when the mouthpiece cover is opened. The device delivers a consistent and reliable dose across a range of inspiratory flow rates, which is important for patients who may have difficulty generating high flow rates, particularly those with more severe airway obstruction.
Studies comparing the Spiromax device with other dry powder inhalers, including the Turbuhaler, have shown that patients find the Spiromax easier to use and make fewer critical errors during inhalation. Correct inhaler technique is a fundamental factor in achieving optimal drug delivery to the lungs and, consequently, effective disease control. In clinical practice, inhaler misuse is a significant and common problem, contributing to poor disease control and unnecessary healthcare utilization. The intuitive design of the Spiromax device aims to address this challenge.
International guidelines (GINA, GOLD) strongly recommend against using a LABA alone (without an ICS) for the treatment of asthma, as monotherapy with a LABA has been associated with an increased risk of serious asthma-related adverse events, including hospitalization and death. BiResp Spiromax ensures that patients always receive the anti-inflammatory ICS component alongside the LABA, providing both symptom relief and control of the underlying disease process.
What Should You Know Before Taking BiResp Spiromax?
Contraindications
BiResp Spiromax is contraindicated in patients with known hypersensitivity (allergy) to budesonide, formoterol fumarate dihydrate, or to the excipient lactose monohydrate (which contains small amounts of milk proteins). If you have a known allergy to any of these substances, you must not use BiResp Spiromax. Allergic reactions to inhaled medications can manifest as bronchospasm (paradoxical tightening of the airways), skin rash, urticaria (hives), or angioedema (swelling of the face, lips, tongue, or throat). If you experience any of these symptoms after using BiResp Spiromax, stop using the inhaler and seek medical attention immediately.
Warnings and Precautions
BiResp Spiromax is a maintenance (preventer) inhaler. It should not be used to treat sudden attacks of breathlessness or wheezing (acute bronchospasm). Always keep a rapid-acting bronchodilator (reliever inhaler, such as salbutamol/albuterol) available for acute symptom relief. If your symptoms are worsening or you are using your reliever inhaler more frequently, contact your doctor promptly.
Before starting BiResp Spiromax, inform your healthcare provider about the following conditions, as they may require special monitoring, dose adjustments, or additional precautions:
- Cardiovascular disease: Formoterol, like other beta2-agonists, can cause cardiovascular effects including increased heart rate (tachycardia), palpitations, and changes in blood pressure. Patients with coronary artery disease, heart rhythm disorders (arrhythmias), hypertrophic cardiomyopathy, aortic stenosis, or other significant cardiovascular conditions should use BiResp Spiromax with caution and under close medical supervision.
- Diabetes mellitus: High doses of beta2-agonists can temporarily increase blood glucose levels due to glycogenolysis. Patients with diabetes should monitor their blood glucose more frequently when starting BiResp Spiromax, as dose adjustments of antidiabetic medications may be necessary.
- Thyroid disorders: Beta2-agonists can exacerbate symptoms of thyrotoxicosis (overactive thyroid). Patients with untreated or poorly controlled hyperthyroidism should be monitored carefully.
- Low potassium (hypokalemia): Beta2-agonists can cause a decrease in serum potassium levels. This effect may be compounded by concomitant treatment with xanthine derivatives (e.g., theophylline), corticosteroids, or diuretics. Severe hypokalemia can potentially lead to cardiac arrhythmias. Serum potassium levels should be monitored in patients at risk.
- Adrenal insufficiency: Patients transferring from systemic (oral) corticosteroids to inhaled corticosteroids may have suppressed adrenal function. The transition should be gradual, with careful monitoring for signs of adrenal insufficiency such as fatigue, weakness, nausea, and low blood pressure, particularly during periods of physiological stress (e.g., surgery, illness, severe trauma).
- Tuberculosis (TB): Patients with active or quiescent pulmonary tuberculosis, or untreated fungal, viral, or bacterial respiratory infections, should be monitored carefully, as inhaled corticosteroids may suppress local immune defenses in the airways.
- Osteoporosis: Long-term use of high doses of inhaled corticosteroids may reduce bone mineral density. Patients who are at risk for osteoporosis (e.g., postmenopausal women, elderly patients, those with a family history of osteoporosis) should discuss preventive measures with their doctor.
Pregnancy and Breastfeeding
If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor before using BiResp Spiromax. Uncontrolled asthma during pregnancy carries significant risks for both mother and baby, including pre-eclampsia, low birth weight, premature birth, and increased perinatal mortality. Maintaining adequate asthma control during pregnancy is therefore essential.
Budesonide is the most extensively studied inhaled corticosteroid in pregnancy. Data from large epidemiological studies and pregnancy registries involving thousands of exposed pregnancies have not demonstrated an increased risk of congenital malformations or adverse fetal outcomes with inhaled budesonide use during pregnancy. International guidelines, including GINA, recommend that pregnant women with asthma should continue their controller therapy (including ICS) to prevent exacerbations. Data on formoterol use during pregnancy are more limited. Animal reproductive studies have not shown adverse effects at clinically relevant doses, but human data are insufficient to fully assess the risk. As a precaution, BiResp Spiromax should be used during pregnancy only if the expected benefit to the mother justifies any potential risk to the fetus.
Budesonide is excreted in breast milk at concentrations much lower than therapeutic doses. At therapeutic inhaled doses, the amount of budesonide reaching the nursing infant is expected to be negligible. Formoterol excretion in human breast milk has not been studied, but it is found in the milk of lactating rats. A decision should be made whether to continue breastfeeding during BiResp Spiromax treatment, taking into account the benefit of breastfeeding to the child and the benefit of treatment to the mother.
Children and Adolescents
BiResp Spiromax 160/4.5 micrograms is indicated for use in adults aged 18 years and older only. It is not recommended for use in children and adolescents under 18 years of age. Children and adolescents with asthma should use age-appropriate ICS/LABA formulations as recommended by their healthcare provider.
Driving and Operating Machinery
BiResp Spiromax is not known to affect the ability to drive or operate machinery. However, if you experience side effects such as dizziness, tremor, or visual disturbances, you should refrain from driving or operating heavy machinery until these symptoms resolve.
How Does BiResp Spiromax Interact with Other Drugs?
Drug interactions with BiResp Spiromax can be clinically significant and fall into two main categories: interactions affecting the corticosteroid component (budesonide) and interactions affecting the beta2-agonist component (formoterol). Understanding these interactions is important for safe and effective use of the medication.
Major Interactions
The following drug interactions are considered clinically significant and may require dose adjustments, additional monitoring, or avoidance of concomitant use:
| Drug/Class | Interaction | Clinical Significance |
|---|---|---|
| CYP3A4 inhibitors (ketoconazole, itraconazole, ritonavir, nelfinavir, cobicistat) | Inhibit the metabolism of budesonide, increasing systemic exposure up to 7-fold | Increased risk of systemic corticosteroid effects (Cushing syndrome, adrenal suppression). Avoid concomitant use if possible; if required, use lowest effective dose and monitor closely. |
| Beta-adrenergic blockers (propranolol, carvedilol, timolol) | Block beta2-receptors, reducing or abolishing the bronchodilatory effect of formoterol | Non-selective beta-blockers are contraindicated in asthma. Cardioselective beta-blockers (e.g., bisoprolol, metoprolol) should be used with caution if necessary. |
| QTc-prolonging drugs (sotalol, amiodarone, certain antipsychotics, macrolide antibiotics) | Additive effect on QTc interval prolongation with formoterol | Increased risk of ventricular arrhythmias. Use with caution; ECG monitoring may be warranted. |
| MAO inhibitors and tricyclic antidepressants | May potentiate cardiovascular effects of formoterol (increased heart rate, blood pressure effects) | Use with caution. Monitor cardiovascular parameters. |
Other Interactions
| Drug/Class | Interaction | Clinical Significance |
|---|---|---|
| Diuretics (furosemide, hydrochlorothiazide) | May enhance the potassium-lowering effect of beta2-agonists | Monitor serum potassium, particularly in patients receiving high doses or concomitant xanthine derivatives. |
| Xanthine derivatives (theophylline, aminophylline) | Additive hypokalemic effect with formoterol; may also increase heart rate | Monitor potassium levels and cardiac rhythm when used together. |
| Other sympathomimetics (salbutamol, terbutaline) | Additive beta2-adrenergic effects (tremor, tachycardia, hypokalemia) | Short-acting beta2-agonists may be used as rescue medication, but excessive use should be avoided. |
| L-dopa, L-thyroxine, oxytocin, alcohol | May reduce cardiac tolerance to sympathomimetic agents | Use with caution in patients receiving these medications. |
It is important to inform your doctor or pharmacist about all medications you are currently taking, including over-the-counter medicines, herbal supplements, and vitamins. This is especially relevant for BiResp Spiromax because its two active components can interact with different drug classes through different mechanisms. Your healthcare provider can assess the potential for interactions and adjust your treatment plan accordingly.
Budesonide is metabolized primarily by the cytochrome P450 enzyme CYP3A4. Potent inhibitors of this enzyme (such as the antifungal drugs ketoconazole and itraconazole, and the HIV protease inhibitors ritonavir and nelfinavir) can dramatically increase systemic exposure to budesonide, potentially leading to Cushing syndrome and adrenal suppression. In a pharmacokinetic study, concomitant administration of ketoconazole 200 mg once daily increased plasma budesonide levels by an average of 7-fold. If concomitant use cannot be avoided, the time interval between the CYP3A4 inhibitor and budesonide should be as long as possible, and a reduction in the budesonide dose should be considered.
What Is the Correct Dosage of BiResp Spiromax?
BiResp Spiromax should always be used exactly as your doctor has instructed. The dosage depends on the severity of your condition, your current level of disease control, and the specific treatment regimen prescribed. BiResp Spiromax is a maintenance (preventer) inhaler and should be used regularly every day, even during periods when you have no symptoms. Do not stop using it suddenly without consulting your doctor, as this may lead to a worsening of your condition.
Adults – Asthma
| Treatment Approach | Dose | Frequency | Max Daily Dose |
|---|---|---|---|
| Maintenance therapy | 1–2 inhalations | Twice daily (morning and evening) | 4 inhalations (640/18 mcg) |
| Maintenance & reliever (MART) | 2 inhalations maintenance + additional as needed | Twice daily + as needed for symptoms | 8 inhalations total (including reliever doses) |
In the maintenance therapy approach, BiResp Spiromax is used as a fixed daily preventer, and a separate rapid-acting bronchodilator (such as salbutamol) is used as needed for acute symptom relief. In the maintenance and reliever therapy (MART) approach, BiResp Spiromax serves as both the daily preventer and the as-needed reliever. When used in MART, patients take their regular maintenance dose plus additional inhalations as needed for symptom relief. The maximum total dose should not exceed 8 inhalations per day on a temporary basis, and patients should be advised to seek medical attention if they regularly need more than their maintenance dose.
Adults – COPD
COPD Maintenance Dose
2 inhalations twice daily (morning and evening), providing a total daily dose of budesonide 640 micrograms and formoterol 18 micrograms. This is the recommended and maximum dose for COPD.
In COPD, BiResp Spiromax is used as a maintenance preventer and is not intended as reliever therapy. Patients should continue to have a separate rapid-acting bronchodilator available for acute symptom relief. The benefit of ICS-containing therapy in COPD is primarily a reduction in the frequency of exacerbations. Patients should be reviewed regularly, and if the COPD remains stable over a prolonged period, the treating physician may consider whether the ICS component remains necessary.
Children and Adolescents
BiResp Spiromax 160/4.5 micrograms is not indicated for use in children and adolescents under 18 years of age. Alternative budesonide/formoterol formulations with appropriate strengths and devices are available for pediatric patients and should be prescribed as appropriate.
Elderly Patients
No dose adjustment is required for elderly patients. However, elderly patients may be more susceptible to systemic effects of inhaled corticosteroids (e.g., osteoporosis, cataracts, glaucoma) and the cardiovascular effects of beta2-agonists (e.g., tachycardia, tremor). Regular monitoring, including periodic bone density assessments and eye examinations, should be considered for elderly patients on long-term therapy.
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 take your next dose at the usual time. Do not take a double dose to make up for a forgotten dose. If you frequently forget doses, consider setting a daily alarm or using a medication reminder application to help maintain a consistent dosing schedule. Consistent daily use is essential for achieving and maintaining optimal disease control.
Overdose
An overdose of formoterol may cause tremor, headache, palpitations, tachycardia, nausea, and in severe cases, metabolic acidosis, hypokalemia, and hyperglycemia. An overdose of budesonide is unlikely to cause acute clinical problems. Chronic overuse of inhaled budesonide at very high doses may lead to systemic corticosteroid effects such as adrenal suppression. If overdose occurs, treatment is supportive and symptomatic. Serum potassium levels should be monitored. There is no specific antidote for formoterol or budesonide overdose. Contact your doctor, pharmacist, or local poison control center for advice.
How to Use the Spiromax Inhaler
Correct inhaler technique is critical for ensuring that the medication reaches the lungs effectively. The Spiromax is a breath-actuated dry powder inhaler, meaning that the dose is released automatically when you breathe in through the device. Follow these steps carefully:
- Open: Hold the inhaler upright with the mouthpiece cover at the bottom. Open the mouthpiece cover by folding it down fully until you hear a click. The inhaler is now loaded with one dose. Do not shake the inhaler.
- Breathe out: Breathe out gently, away from the inhaler. Do not breathe out into the mouthpiece, as moisture can affect the powder.
- Inhale: Place the mouthpiece between your lips and seal your lips firmly around it. Breathe in deeply and forcefully through the mouth. The powder is taste-free and odorless, so you may not feel or taste the dose — this is normal.
- Hold your breath: Remove the inhaler from your mouth. Hold your breath for approximately 5–10 seconds, or as long as is comfortable, to allow the medication to settle in the lungs.
- Close: Breathe out slowly through the nose. Close the mouthpiece cover. If a second inhalation is required, repeat all steps from step 1.
- Rinse: After the final inhalation, rinse your mouth with water and spit it out. Do not swallow the rinse water. This helps prevent oral thrush (candidiasis) and hoarseness.
The Spiromax inhaler has a dose counter on the back that shows how many doses are remaining. It starts at 60 and counts down with each inhalation. When the counter reaches 0, the inhaler is empty and should be replaced. Do not try to take further doses from an empty inhaler, as you will not receive the correct amount of medication. Keep a spare inhaler available so you do not run out unexpectedly.
What Are the Side Effects of BiResp Spiromax?
Like all medicines, BiResp Spiromax can cause side effects, although not everyone experiences them. The side effects are related to its two active components: budesonide (corticosteroid) and formoterol (beta2-agonist). Many of the side effects listed below are class effects of these drug categories and are well characterized from decades of clinical experience with inhaled corticosteroids and long-acting beta2-agonists.
The following side effects have been reported with BiResp Spiromax and budesonide/formoterol combination products in clinical trials and post-marketing surveillance. They are organized by frequency according to the standard Medical Dictionary for Regulatory Activities (MedDRA) classification.
Very Common
May affect more than 1 in 10 people
- Oral candidiasis (thrush) — fungal infection of the mouth and throat caused by the ICS component
Common
May affect up to 1 in 10 people
- Headache
- Tremor (shakiness, especially of the hands)
- Palpitations (awareness of heartbeat)
- Hoarseness (dysphonia) — caused by ICS deposition on the vocal cords
- Mild sore throat (pharyngitis)
- Cough after inhalation
- Nausea
Uncommon
May affect up to 1 in 100 people
- Tachycardia (rapid heartbeat)
- Muscle cramps
- Dizziness
- Sleep disturbances (insomnia)
- Restlessness, nervousness, agitation
- Skin bruising
- Candidiasis of the esophagus
Rare
May affect up to 1 in 1,000 people
- Paradoxical bronchospasm (sudden worsening of breathing immediately after inhalation)
- Cardiac arrhythmias (including atrial fibrillation, supraventricular tachycardia, extrasystoles)
- Angioedema (swelling of the face, lips, tongue, or throat)
- Skin rash, urticaria (hives)
- Depression or behavioral changes
Not Known
Frequency cannot be estimated from available data
- Adrenal suppression (with prolonged high-dose use)
- Growth retardation in children and adolescents
- Decreased bone mineral density
- Glaucoma and cataracts (with long-term high-dose ICS use)
- Hyperglycemia (elevated blood sugar)
- Hypokalemia (low potassium)
- Pneumonia (particularly in COPD patients receiving ICS)
- Psychiatric effects: psychomotor hyperactivity, anxiety, sleep disorders, aggression (particularly in children)
Oral candidiasis is the most commonly reported side effect with budesonide-containing inhalers. It occurs because the corticosteroid deposited in the oral cavity suppresses local immune defenses, allowing the fungus Candida albicans to proliferate. The risk of oral candidiasis can be significantly reduced by rinsing the mouth with water (and spitting it out) after each inhalation. If oral thrush develops despite mouth rinsing, it can usually be treated effectively with an antifungal mouthwash or oral antifungal medication prescribed by your doctor.
Tremor and palpitations are common class effects of beta2-agonists like formoterol. These effects are typically mild, dose-related, and tend to diminish with continued regular use as the body develops tolerance. If tremor or palpitations are bothersome, discuss with your doctor whether a dose adjustment may be appropriate.
Pneumonia has been observed at an increased rate in clinical trials of COPD patients receiving inhaled corticosteroids, including budesonide. The GINA and GOLD guidelines acknowledge this risk and recommend that clinicians weigh the benefits of ICS therapy (reduced exacerbations) against the potential risk of pneumonia in individual COPD patients. COPD patients should be monitored for signs of pneumonia, and the diagnosis of COPD exacerbation versus pneumonia can be clinically challenging.
In rare cases, inhalation of BiResp Spiromax may cause paradoxical bronchospasm — a sudden tightening of the airways immediately after inhalation, with worsening wheezing and shortness of breath. If this occurs, stop using BiResp Spiromax immediately, use your rapid-acting reliever inhaler, and seek medical attention. Paradoxical bronchospasm may be related to the powder excipient or to an idiosyncratic reaction. Your doctor will assess whether an alternative inhaler device or formulation should be used.
Contact your doctor immediately if you experience: sudden worsening of breathlessness after inhalation, swelling of the face, lips, tongue or throat, severe skin rash or hives, chest pain or irregular heartbeat, signs of pneumonia (fever, increased cough, purulent sputum, shortness of breath), or signs of adrenal insufficiency (extreme tiredness, weakness, nausea, dizziness).
How Should You Store BiResp Spiromax?
Proper storage is essential to maintain the quality and effectiveness of BiResp Spiromax. As a dry powder inhaler, the medication is particularly sensitive to moisture, which can cause the powder to clump and reduce dose delivery. Follow these storage guidelines:
- Temperature: Store below 25°C (77°F). Do not expose to extreme heat or direct sunlight. There is no need to refrigerate BiResp Spiromax.
- Do not freeze: Freezing can damage the inhaler mechanism and the medication.
- Protect from moisture: Always keep the mouthpiece cover closed when the inhaler is not in use. Do not store the inhaler in humid environments such as bathrooms.
- Keep out of reach of children: Store BiResp Spiromax in a safe location where children cannot access it.
- Expiration date: Do not use BiResp Spiromax after the expiration date printed on the label and carton. The expiration date refers to the last day of that month.
- Shelf life after first opening: Once removed from the foil pouch (if applicable), use the inhaler within the timeframe specified on the packaging, typically within 3 months.
- Disposal: Do not throw away the inhaler via household waste. Ask your pharmacist about proper disposal of unused or expired medications.
When traveling with BiResp Spiromax, keep it in your hand luggage where temperatures are more controlled. Avoid leaving the inhaler in a car during hot weather. The Spiromax device is robust and does not contain propellants, but the dry powder can be affected by extreme humidity. If you are traveling to tropical or humid climates, consider carrying the inhaler in a small sealed plastic bag to provide additional moisture protection.
What Does BiResp Spiromax Contain?
Active Ingredients
BiResp Spiromax contains two active substances that work together to treat asthma and COPD:
| Ingredient | Role | Amount per Inhalation |
|---|---|---|
| Budesonide | Inhaled corticosteroid (ICS) — reduces airway inflammation | 160 micrograms (delivered dose) |
| Formoterol fumarate dihydrate | Long-acting beta2-agonist (LABA) — relaxes bronchial smooth muscle | 4.5 micrograms (delivered dose) |
| Lactose monohydrate | Carrier excipient — improves powder flow and dose consistency | Contains small amounts of milk proteins |
Lactose monohydrate is a sugar derived from milk that serves as a carrier for the fine drug particles, helping them to flow through the device and be deposited consistently in the lungs during inhalation. The lactose used in dry powder inhalers contains trace amounts of milk proteins. Although the quantity is very small, patients with severe lactose intolerance or known allergy to milk proteins should discuss this with their doctor before using BiResp Spiromax.
Appearance and Pack Sizes
BiResp Spiromax is a white to off-white inhalation powder contained within a white plastic inhaler with a semi-transparent wine-red mouthpiece cover. Each inhaler contains 60 metered doses. The device features a dose counter on the back panel. BiResp Spiromax is available in packs of 1, 2, or 3 inhalers. Not all pack sizes may be marketed in every country.
Marketing Authorization
BiResp Spiromax is developed and manufactured by Teva Pharmaceuticals. It received marketing authorization from the European Medicines Agency (EMA) via the decentralized procedure and is available in multiple European countries. BiResp Spiromax is bioequivalent to the budesonide/formoterol combination delivered via the Turbuhaler device (marketed as Symbicort Turbuhaler), meaning it delivers the same active substances to the lungs at the same doses and produces similar clinical effects.
Frequently Asked Questions About BiResp Spiromax
BiResp Spiromax is a combination inhaler used for the regular maintenance treatment of asthma in adults aged 18 years and older, and for the symptomatic treatment of severe chronic obstructive pulmonary disease (COPD) in adults with a history of frequent exacerbations. It contains budesonide, an inhaled corticosteroid that reduces airway inflammation, and formoterol, a long-acting bronchodilator that relaxes the muscles in the airways. Together, these two substances help to control symptoms, improve lung function, prevent exacerbations, and maintain quality of life.
BiResp Spiromax and Symbicort Turbuhaler contain the same active ingredients (budesonide and formoterol) at the same doses. The primary difference is the inhaler device: BiResp Spiromax uses the Spiromax dry powder inhaler, while Symbicort uses the Turbuhaler device. Clinical studies have shown that the two products are bioequivalent, meaning they deliver the same amount of medication to the lungs. Some patients may find one device easier to use than the other. The Spiromax device uses a simple open-inhale-close technique and has been shown in studies to result in fewer critical inhaler technique errors compared to some other devices. Your doctor or respiratory nurse can help you determine which device is most appropriate for you.
BiResp Spiromax is primarily a maintenance (preventer) inhaler and is not designed as a stand-alone rescue inhaler for acute asthma attacks. You should always carry a separate rapid-acting bronchodilator (reliever inhaler, such as salbutamol/albuterol) for emergency use. However, your doctor may prescribe BiResp Spiromax as part of a maintenance and reliever therapy (MART) regimen, in which case additional inhalations can be taken for acute symptom relief on top of your regular maintenance dose, up to a maximum of 8 inhalations per day. Always follow your doctor’s specific instructions.
Oral thrush (candidiasis) is the most common side effect of inhaled corticosteroids like budesonide. You can significantly reduce the risk by rinsing your mouth thoroughly with water after each inhalation session and spitting the water out (do not swallow). Some patients also find it helpful to use the inhaler before meals, so that eating and drinking afterward helps to clear residual medication from the mouth and throat. If you develop white patches in your mouth, soreness, or difficulty swallowing, consult your doctor, who may prescribe an antifungal treatment.
If you miss a dose, take it as soon as you remember. If it is almost time for your next scheduled dose, skip the missed dose and continue with your normal routine. Do not take a double dose to make up for a forgotten one. Consistent daily use of BiResp Spiromax is important for maintaining stable asthma and COPD control. Setting a daily alarm or using a medication reminder app can help you remember to take your doses at the same time each day.
The BiResp Spiromax inhaler has a dose counter on the back of the device that counts down from 60 with each inhalation. When the counter reaches 0, the inhaler is empty and should be replaced. The last 10 doses are indicated in red on the dose counter to give you advance warning. It is advisable to have a replacement inhaler available before your current one runs out. Do not attempt to take doses from an empty inhaler, and do not try to open or modify the device.
References
- European Medicines Agency (EMA). BiResp Spiromax – Summary of Product Characteristics. Last updated 2025. Available at: www.ema.europa.eu
- Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention, 2024 Update. Available at: ginasthma.org
- Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global Strategy for the Diagnosis, Management, and Prevention of COPD, 2024 Report. Available at: goldcopd.org
- British National Formulary (BNF). Budesonide with formoterol. National Institute for Health and Care Excellence (NICE), 2025.
- Virchow JC, et al. “A Review of the Value of Inhaler Device Standardization in Asthma and COPD.” Journal of Aerosol Medicine and Pulmonary Drug Delivery. 2019;32(5):311–323.
- Chrystyn H, et al. “Inhaler competence in asthma: Common errors, barriers to use and recommended solutions.” Respiratory Medicine. 2017;119:22–31.
- World Health Organization (WHO). Model List of Essential Medicines, 23rd list, 2023. Budesonide and formoterol listed for respiratory conditions.
- Kew KM, Dahri K. “Long-acting muscarinic antagonists (LAMA) added to combination long-acting beta2-agonists and inhaled corticosteroids (LABA/ICS) versus LABA/ICS for adults with asthma.” Cochrane Database of Systematic Reviews. 2016;(1):CD011721.
- Lipworth BJ, et al. “Pharmacokinetics, efficacy, and safety of the Spiromax dry powder inhaler.” Expert Opinion on Drug Delivery. 2016;13(2):281–293.
- Norjävaara E, et al. “Budesonide in pregnancy: Registry-based study of over 24,000 pregnancies.” Journal of Allergy and Clinical Immunology. 2003;111(4):736–742.
Medical Editorial Team
Medical Content
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