What is the most important information I should know about this medicine?
Fluticasone, umeclidinium, and vilanterol is for use only in people with chronic obstructive pulmonary disease (COPD) and should not be used to treat asthma.
This medicine will not work fast enough to treat a bronchospasm attack. Use only a fast acting inhalation medicine for an attack.
Vilanterol may increase the risk of death in people with asthma, but the risk in people with COPD is not known. Seek medical attention if your breathing problems do not improve, or if your symptoms get worse quickly.
What is fluticasone, umeclidinium, and vilanterol?
Fluticasone is a steroid that prevents the release of substances in the body that cause inflammation.
Umeclidinium is an anticholinergic. Vilanterol is a bronchodilator. These medications work by relaxing muscles in the airways to improve breathing.
Fluticasone, umeclidinium, and vilanterol is a combination medicine used to improve symptoms and prevent bronchospasm in adults with COPD (chronic obstructive pulmonary disease), including bronchitis and emphysema.
Fluticasone, umeclidinium, and vilanterol may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before using this medicine?
You should not use this medicine if you are allergic to fluticasone, umeclidinium, vilanterol, or milk proteins. Fluticasone, umeclidinium, and vilanterol is for use only in people with COPD and should not be used to treat asthma.
To make sure this medicine is safe for you, tell your doctor if you have ever had:
- heart disease, high blood pressure;
- a seizure;
- a weak immune system;
- any type of infection, including tuberculosis or herpes infection of the eyes;
- liver disease;
- glaucoma or cataracts;
- diabetes (or ketoacidosis);
- osteoporosis;
- a thyroid disorder; or
- an enlarge prostate, bladder obstruction, or urination problems.
Vilanterol may increase the risk of death in people with asthma, but the risk in people with COPD is not known. Talk with your doctor about your individual risks and benefits of using this medicine. Follow all patient instructions for safe use.
It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
It is not known whether fluticasone, umeclidinium, and vilanterol passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.
This medicine is not approved for use by anyone younger than 18 years old.
How should I use this medicine?
Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.
Using this medicine improperly can cause death or serious side effects on the heart.
Fluticasone, umeclidinium, and vilanterol is a powder that comes with a special inhaler device preloaded with blister packs containing measured doses of the medicine. The device opens and loads a blister of the medicine each time you use the inhaler. Follow the patient instructions provided with the inhaler device.
You may need to stop using other COPD medications you have been using in the past on a regular basis. Carefully follow your doctor's dosing instructions.
Fluticasone, umeclidinium, and vilanterol will not work fast enough to treat a bronchospasm attack. Use only a fast-acting inhalation medicine for an attack. Tell your doctor if any of your medicines seem to stop working as well in controlling your COPD.
The usual dose of this medicine is 1 inhalation per day. Use the medicine at the same time each day, and not more than once in a 24-hour period.
Seek medical attention if your breathing problems do not improve, or if your symptoms get worse quickly.
To reduce the chance of developing a yeast infection in your mouth, rinse with water (but do not swallow) after using this medicine.
While using this medicine, you may need frequent blood tests. Your vision and your bone mineral density may also need to be checked.
Store at room temperature away from moisture, heat, and light. Keep the inhaler device in the sealed foil tray until ready to start using it.
Throw the inhaler device away 6 weeks after you have taken it out of the foil pouch, or if the dose indicator shows a zero, whichever comes first.
What happens if I miss a dose?
Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose. Do not use more than 1 inhalation in a single day.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Overdose symptoms may include chest pain, fast heart rate, and feeling shaky or short of breath.
What should I avoid while using this medicine?
Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chickenpox or measles. These conditions can be serious or even fatal in people who are using medicine that contains a steroid.
Do not use a second inhaled bronchodilator similar to vilanterol, such as salmeterol (Advair, Serevent), indacaterol (Arcapta), formoterol or arformoterol (Foradil, Perforomist, Symbicort, Brovana).
What are the possible side effects of fluticasone, umeclidinium, and vilanterol?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- chest pain, fast or pounding heartbeats, pounding in your neck or ears;
- anxiety, tremors, nervousness;
- wheezing, choking, or other breathing problems after using this medication;
- painful or difficult urination;
- feeling very weak or tired, vomiting, and feeling like you might pass out;
- sores or white patches in your mouth and throat, pain when swallowing;
- fever, chills, cough with yellow or green mucus; or
- blurred vision, tunnel vision, eye pain, or seeing halos around lights.
Common side effects may include:
- cough;
- pain in you mouth or throat;
- nausea, vomiting, diarrhea;
- headache, back pain; or
- changes in your sense of taste.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect fluticasone, umeclidinium, and vilanterol?
Tell your doctor about all your current medicines and any you start or stop using, especially:
- atropine;
- antifungal or antiviral medicine;
- cold or allergy medicine that contains an antihistamine (Benadryl and others);
- medicine to treat Parkinson's disease;
- medicine to treat excess stomach acid, stomach ulcer, motion sickness, or irritable bowel syndrome;
-
bladder or urinary medicines --darifenacin, fesoterodine, oxybutynin, tolterodine, solifenacin; or
-
bronchodilators --aclidinium, ipratropium, tiotropium, umeclidinium.
Other drugs may interact with fluticasone, umeclidinium, and vilanterol, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.
Where can I get more information?
Your pharmacist can provide more information about fluticasone, umeclidinium, and vilanterol.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Copyright 1996-2018 Cerner Multum, Inc. Version: 1.01. Revision date: 11/15/2017.
