Generic Name: aclidinium bromide and formoterol fumarate
Dosage Form: Powder for Oral Inhalation
Date of Approval: March 29, 2019
Company: Circassia Pharmaceuticals plc
Treatment for: Chronic Obstructive Pulmonary Disease
Medically reviewed by J. Stewart, BPharm. Last updated on Apr 15, 2019.
Read this Patient Information before you start treatment. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.
Important: Do not get Duaklir Pressair in your eyes.
What is Duaklir Pressair?
Duaklir Pressair combines an anticholinergic, aclidinium bromide, and a long-acting beta2-adrenergic agonist (LABA medicine) formoterol fumarate.
- Anticholinergic and LABA medicines help the muscles around the airways in your lungs stay relaxed to prevent symptoms such as wheezing, cough, chest tightness, and shortness of breath. These symptoms can happen when the muscles around the airways tighten. This makes it hard to breathe.
- Duaklir Pressair is a prescription medicine that is used to treat COPD. COPD is a chronic lung disease that includes chronic bronchitis, emphysema, or both.
- Duaklir Pressair is used long term as one inhalation two times each day to improve symptoms of COPD for better breathing and to reduce the number of flare-ups (the worsening of your COPD symptoms for several days).
- Duaklir Pressair is not for use to treat sudden symptoms of COPD. Always have a rescue inhaler (shortacting beta2 agonist medicine) with you to treat sudden symptoms of COPD. If you do not have a rescue inhaler, contact your healthcare provider to have one prescribed for you.
- Duaklir Pressair is not for the treatment of asthma. It is not known if Duaklir Pressair is safe and effective in people with asthma.
- Duaklir Pressair should not be used in children. It is not known if Duaklir Pressair is safe and effective in children.
Who should not use Duaklir Pressair?
Do not use Duaklir Pressair if you:
- have asthma and you use Duaklir Pressair without also using a medicine called an inhaled corticosteroid.
- have a severe allergy to milk proteins. Ask your healthcare provider if you are not sure.
- are allergic to aclidinium bromide, formoterol fumarate, or any of the other ingredients. See the bottom of this page for a complete list of ingredients.
Before using Duaklir Pressair
Before you use Duaklir Pressair tell your healthcare provider about all of your medical conditions, including if you:
- have heart problems
- have high blood pressure
- have seizures
- have thyroid problems
- have diabetes
- have eye problems especially glaucoma. Duaklir Pressair may make your glaucoma worse.
- have prostate or bladder problems, or problems passing urine. Duaklir Pressair may make these problems worse.
- are pregnant or plan to become pregnant. It is not known if Duaklir Pressair can harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if the medicines, aclidinium bromide and formoterol fumarate in Duaklir Pressair pass into your breast milk and if they can harm your baby.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Duaklir Pressair and certain other medicines may interact with each other. This may cause serious side effects. Especially tell your healthcare provider if you take:
- anticholinergics (including umeclidinium, tiotropium, ipratropium, aclidinium, glycopyrrolate).
- other LABA medicines (including formoterol, arformoterol, salmeterol, vilanterol, indacaterol, olodaterol).
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should I use Duaklir Pressair?
Read the step-by-step instruction leaflet that comes with your prescription.
- Do not use Duaklir Pressair unless your healthcare provider has taught you how to use the inhaler and you understand how to use it correctly.
- Use the inhaler exactly as prescribed. Do not use the inhaler more often than prescribed.
- Use one inhalation two times each day. Use the inhaler one time in the morning and one time in the evening.
- If you miss a dose, skip the missed dose. Take your next dose at your usual time. Do not take more than one inhalation two times each day. Do not take two doses at one time.
- If you take too much Duaklir Pressair, call your healthcare provider and get medical help right away if you have any unusual symptoms, such as worsening shortness of breath, chest pain, increased heart rate, or shakiness.
- Do not use other medicines that contain a LABA for any reason. Ask your healthcare provider or pharmacist if any of your other medicines are LABA medicines.
- Do not stop using Duaklir Pressair unless told to do so by your healthcare provider because your symptoms might get worse. Your healthcare provider will change your medicines as needed.
- Duaklir Pressair does not relieve sudden symptoms. Always have a rescue inhaler with you to treat sudden symptoms. If you do not have a rescue inhaler, call your healthcare provider to have one prescribed for you.
- Call your healthcare provider or get medical care right away if your breathing problems get worse, you need to use your rescue inhaler more often than usual, your rescue inhaler does not work as well to relieve your symptoms.
Duaklir Pressair side effects
Duaklir Pressair can cause serious side effects including:
- people with asthma who take LABA medicines, such as formoterol fumarate (one of the medicines in Duaklir Pressair), without also using a medicine called an inhaled corticosteroid, have an increased risk of serious problems from asthma, including being hospitalized, needing a tube placed in their airway to help them breathe or death.
- Call your healthcare provider if breathing problems worsen over time with using Duaklir Pressair. You may need a different treatment.
- Get emergency medical care if:
- your breathing problems worsen quickly
- you use your rescue inhaler, but it does not relieve your breathing problems
- COPD symptoms that get worse over time. If your COPD symptoms worsen over time, do not increase your dose of Duaklir Pressair, call your healthcare provider.
- using too much of a LABA medicine may cause:
- chest pain
- fast and irregular heartbeat
- increased blood pressure
- sudden breathing problems immediately after use of Duaklir Pressair. These sudden breathing problems may be life-threatening. If you have sudden breathing problems immediately after inhaling Duaklir Pressair, stop using the inhaler and call your healthcare provider right away or go to the nearest hospital emergency room.
- serious allergic reactions. Call your doctor or get emergency medical care if you get any symptoms of a serious allergic reaction.
- swelling of the face, mouth and tongue
- breathing problems
- effects on your heart:
- chest pain
- increased blood pressure
- fast or irregular heartbeat
- changes in laboratory blood levels: high blood sugar (hyperglycemia) and low blood potassium (hypokalemia), this last may cause symptoms of muscle spasms, muscle weakness, or abnormal heart rhythm.
- new or worsened increased pressure in your eyes (acute narrow-angle glaucoma). Acute narrow-angle glaucoma can lead to permanent loss of vision if not treated. Symptoms of acute narrow-angle glaucoma may include:
- eye pain or discomfort
- seeing halos or bright colors around lights
- nausea or vomiting
- red eyes
- blurred vision
- new or worsened urinary retention. Urinary retention can be caused by blockage in your bladder or, if you are a male, a larger than normal prostate. Symptoms of urinary retention may include:
- difficulty urinating
- painful urination
- urinating frequently
- urination in a weak stream or drips
The most common side effects of Duaklir Pressair include: upper respiratory tract infection and headache.
Tell your healthcare provider about any side effect that bothers you or does not go away.
These are not all the possible side effects. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Duaklir Pressair?
- Store Duaklir Pressair at room temperature between 68°F to 77°F (20°C to 25°C) in the sealed bag that it comes in until you are ready to use the inhaler. Do not open the sealed bag until you are ready to use a dose.
- Keep Duaklir Pressair in a dry place.
- Do not store the inhaler on a vibrating surface.
- Throw away (dispose of) Duaklir Pressair and use a new one:
- when the marking “0” with a red background shows in the middle of the dose indicator,
- if your inhaler is empty and locks out, or
- 2 months after the date you opened the sealed bag that the inhaler comes in, whichever comes first.
Keep all medicines out of the reach of children and pets.
General information about the safe and effective use of Duaklir Pressair
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use this medicine for a condition for which it was not prescribed. Do not give your inhaler to other people, even if they have the same symptoms that you have. It may harm them.
You can ask your doctor or pharmacist for information that is written for healthcare professionals.
What are the ingredients in Duaklir Pressair?
Active ingredient: aclidinium bromide and formoterol fumarate
Inactive ingredient: lactose monohydrate