What is DuoResp Spiromax and what is it used for?

• DuoResp Spiromax is a medicine that contains the active substances budesonide and formoterol. It is used for the treatment of asthma in adults for whom a combination product is considered appropriate. It can be used in patients whose disease is not adequately controlled by treatment with other asthma medicines called corticosteroids and ‘short-acting beta-2 agonists’ taken by inhalation, or in patients whose disease is adequately controlled by treatment with corticosteroids and ‘long-acting beta-2 agonists’ taken by inhalation.
• DuoResp Spiromax is also used to relieve the symptoms of severe chronic obstructive pulmonary disease (COPD) in adults who have had exacerbations (flare–ups) of the disease in the past despite regular treatment. COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty in breathing.

How is DuoResp Spiromax used?

The medicine can only be obtained with a prescription. It is available as an inhalation powder in a portable inhaler device, and each inhalation provides a fixed dose of the medicine. DuoResp Spiromax 160/4.5 microgram (160 micrograms of budesonide and 4.5 micrograms of formoterol) can be used for the regular treatment of asthma and when needed as a reliever. It can also be used for the treatment of COPD. The higher strength, DuoResp Spiromax 320/9 microgram (320 micrograms of budesonide and 9 micrograms of formoterol), can only be used for the regular treatment of asthma and for the treatment of COPD.

• For the regular treatment of asthma, the recommended dose is 1 to 4 inhalations twice a day, depending on the strength being used and the severity of the asthma. As asthma reliever therapy, patients can take 1 or 2 additional inhalations of DuoResp Spiromax 160/4.5 microgram only to relieve their symptoms. If patients need to take more than 8 inhalations per day, it is recommended they speak to their doctor to have their asthma therapy reconsidered.
• For the treatment of COPD, the recommended dose is 1 or 2 inhalations twice a day, depending on the strength being used.
• For further information, see the package leaflet.

How does DuoResp Spiromax work?

• The two active substances in DuoResp Spiromax are well known and are present in several medicines used to treat asthma and COPD, either alone or in combination with other medicines.
• Budesonide belongs to a group of anti-inflammatory medicines known as corticosteroids. It works in a similar way to naturally occurring corticosteroid hormones, reducing the activity of the immune system by attaching to receptors in various types of immune cell. This leads to a reduction in the release of substances that are involved in the inflammation process, such as histamine, thereby helping to keep the airways clear and allowing the patient to breathe more easily.
• Formoterol is a long-acting beta-2 agonist. It works by attaching to receptors known as beta-2 receptors found in the muscles of the airways. When it attaches to these receptors, it causes the muscles to relax, which keeps the airways open and helps with the patient’s breathing.

Before you use DuoResp Spiromax

When you must not use it

Do not use DuoResp Spiromax if you have an allergy to:

• any medicine containing formoterol or budesonide
• any of the ingredients in this medicine

Some of the symptoms of an allergic reaction may include:

• rash, itching or hives on the skin
• shortness of breath, wheezing or difficulty breathing
• swelling of the face, lips, tongue or other parts of the body

Do not give DuoResp Spiromax to a child or adolescent under 18 years.
Do not use DuoResp Spiromax after the expiry date (EXP) printed on the pack.

Before you start to use it

• If you have asthma, ask your doctor or pharmacist if you have any questions about your Asthma Action Plan.
• Your doctor should give you a personal Asthma Action Plan to help manage your asthma. This plan will include what medicines to take regularly to control your asthma, as well as what "reliever" medicines to use when you have sudden attacks of asthma.
• Your doctor may have prescribed DuoResp for you to use as both a "preventer" and "reliever" medicine.
• Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have or have had any of the following medical conditions:

• thyroid or adrenal gland problems
• diabetes
• heart problems
• liver problems
• tuberculosis (TB)
• low levels of potassium in the blood

It may not be safe for you to take DuoResp Spiromax if you have, or have had, any of these conditions.
Tell your doctor if you currently have an infection.
If you take DuoResp Spiromax while you have an infection, the medicine may hide some of the signs of an infection. This may make you think, mistakenly, that you are better or that it is not serious.
Tell your doctor if you are pregnant or intend to become pregnant or breastfeeding.
Your doctor will discuss the possible risks and benefits of using DuoResp Spiromax during pregnancy and while breastfeeding.
If you have not told your doctor or pharmacist about any of the above, tell them before you start using DuoResp Spiromax.

Taking other medicines

Tell your doctor or pharmacist if you are using any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and DuoResp Spiromax may interfere with each other. These include:

• medicines used to treat heart problems or high blood pressure such as beta-blockers, diuretics and antiarrhythmics (disopyramide, procainamide and quinidine)
• medicines used to treat glaucoma such as beta-blockers
• medicines used to treat depression or other mood/mental disorders such as tricyclic antidepressants, monoamine oxidase inhibitors and phenothiazines
• medicines used to treat hayfever, coughs, colds and runny nose such as antihistamines
• medicines used to treat fungal infections (e.g. ketoconazole, itraconazole, voriconazole))
• xanthine derivatives (e.g. theophylline) which are a class of medicines used to treat asthma and COPD.
• Medicines like digoxin used to treat heart failure
• Medicines used to treat HIV infection
• Medicines for Parkinson's disease (e.g. L-dopa)
• Medicines for thyroid problems (e.g. thyroxine

These medicines may be affected by DuoResp Spiromax, or may affect how well it works. You may need different amounts of your medicine, or you may need to use different medicines. Your doctor or pharmacist will advise you.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while using DuoResp Spiromax.

How to use DuoResp Spiromax

Checklist for Spiromax

• Check dose counter
• Hold upright with red mouthpiece cover at the bottom. Do not shake the inhaler.
• Open cover downwards until it clicks.
• Breathe out gently (away from inhaler)
• Put mouthpiece between teeth (without biting) and close lips to form good seal. (Do not cover air vents).
• Breathe in strongly and deeply.
• Remove inhaler from mouth (without breathing out).
• Hold breath for 5 seconds or as long as comfortable.
• Breathe out gently (away from the inhaler).
• Close mouthpiece cover.

If more than one dose is needed, repeat all steps I have just mentioned.

Notes

• It's important to inhale forcefully and deeply ensure the medicine reaches the airways.
• The mouthpiece should not be opened and closed unless a dose is being taken, because each time the mouthpiece is closed, the dose indicator counts down, so it is harder to know when the inhaler is empty.
• The inhaler looks similar to a pressurised metered-dose inhaler – however it is actually different type and the important steps are different.
• The mothpiece cover will still 'click' even when the Spiromax is empty.

References:

https://www.medicines.org.uk/emc/product/3323/pil

https://www.medicines.org.uk/emc/product/3323/smpc

https://www.ema.europa.eu/en/documents/overview/duoresp-spiromax-epar-summary-public_en.pdf

https://www.ema.europa.eu/en/documents/rmp-summary/duoresp-spiromax-epar-risk-management-plan-summary_en.pdf

https://www.news-medical.net/drugs/DuoResp-Spiromax.aspx

https://www.nps.org.au/medicine-finder/duo-resp-spiromax-200-6-powder-for-inhalation

https://www.healthdirect.gov.au/medicines/brand/amt,1103001000168108/duoresp-spiromax-400-12