What is the most important information I should know about fluticasone and vilanterol?
You should not use this medicine if you are allergic to fluticasone, vilanterol, or milk proteins.
Fluticasone and vilanterol is not a rescue medicine. It will not work fast enough to treat an asthma or bronchospasm 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 and vilanterol?
Fluticasone is a steroid that prevents the release of substances in the body that cause inflammation. Vilanterol is a bronchodilator that works by relaxing muscles in the airways to improve breathing.
Fluticasone and vilanterol is a once-daily combination medicine used in adults with asthma or COPD (chronic obstructive pulmonary disease), to improve symptoms and prevent bronchospasm or asthma attacks.
In people with COPD, fluticasone and vilanterol is for long-term treatment. In people with asthma, this medicine is for short-term treatment until symptoms are well-controlled with with other medicines.
Fluticasone and vilanterol may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before using fluticasone and vilanterol?
You should not use this medicine if you are allergic to fluticasone, vilanterol, or milk proteins.
Fluticasone can weaken your immune system, making it easier for you to get an infection or worsening an infection you already have or have recently had. Tell your doctor about any illness or infection you have had within the past several weeks.
To make sure fluticasone and vilanterol is safe for you, tell your doctor if you have:
- a weak immune system;
- heart disease, high blood pressure;
- liver disease;
- glaucoma or cataracts;
- a thyroid disorder;
- seizures;
- diabetes;
- any type of infection, including tuberculosis or herpes infection of the eyes; or
- a personal or family history of osteoporosis.
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 and vilanterol passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
Fluticasone and vilanterol is not approved for use by anyone younger than 18 years old.
How should I use fluticasone and vilanterol?
Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not use this medicine in larger or smaller amounts or for longer than recommended.
Fluticasone 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 fluticasone and vilanterol each time you use the inhaler. Follow the patient instructions provided with the inhaler device.
Fluticasone and vilanterol is not a rescue medicine. It will not work fast enough to treat an asthma or bronchospasm attack. Use only a fast acting inhalation medicine for an asthma attack. Tell your doctor if any of your medicines seem to stop working as well in controlling your symptoms.
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.
Your dose needs may change if you have surgery, are ill, are under stress, or have recently had an asthma attack. Do not change your medication dose or schedule without your doctor's advice.
To reduce the chance of developing a yeast infection in your mouth, rinse with water after using your inhaler. Do not swallow.
Seek medical attention if your breathing problems do not improve, or if your symptoms get worse quickly.
While using this medicine, you may need frequent blood tests. Your vision and your bone mineral density may also need to be checked.
Your doctor will need to check your lung function on a regular basis. Once your asthma is under control, your doctor may want you to stop using fluticasone and vilanterol. Keep all follow-up appointments and do not stop using the medicine unless your doctor tells you to.
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.
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 fluticasone and vilanterol?
Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using a steroid such as fluticasone.
Do not use a second inhaled bronchodilator similar to vilanterol, such as salmeterol (Advair, Serevent), formoterol or arformoterol (Foradil, Perforomist, Symbicort, Brovana) unless your doctor has told you to.
What are the possible side effects of fluticasone 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;
- wheezing, choking, or other breathing problems after using this medication;
- 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:
- headache, back pain, joint pain;
- fever, flu symptoms;
- runny or stuffy nose, sore throat; or
- a hoarse voice.
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 and vilanterol?
Many drugs can interact with fluticasone and vilanterol. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any you start or stop using, especially:
- an antibiotic or antifungal medication;
- an antidepressant;
- a diuretic or "water pill";
- medicine to treat HIV or AIDS;
-
a beta blocker --atenolol, carvedilol, labetalol, metoprolol, nadolol, nebivolol, propranolol, sotalol, and others; or
-
an MAO inhibitor --isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.
This list is not complete and many other drugs can interact with fluticasone and vilanterol. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.
Where can I get more information?
Your pharmacist can provide more information about fluticasone 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.
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