In a large clinical study, more people who used an asthma medication similar to vilanterol experienced severe episodes of asthma that had to be treated in a hospital or caused death than patients who did not use the medication. Use of vilanterol inhalation may increase the risk of serious asthma problems or death in people who have asthma. Umeclidinium and vilanterol inhalation has not been approved by the Food and Drug Administration (FDA) for the treatment of asthma. There is not enough information to tell whether inhaling umeclidinium and vilanterol increases the risk of death in people who have chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways, which includes chronic bronchitis and emphysema).
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with umeclidinium and vilanterol and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website ( Web Site) to obtain the Medication Guide.
Talk to your doctor about the risks of using this medication.
The combination of umeclidinium and vilanterol is used in adults to control wheezing, shortness of breath, coughing, and chest tightness caused by chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways, which includes chronic bronchitis and emphysema). Umeclidinium is in a class of medications called anticholinergics. Vilanterol is in a class of medications called long-acting beta-agonists (LABAs). It works by relaxing and opening air passages in the lungs, making it easier to breathe.
The combination of umeclidinium and vilanterol comes as a powder to inhale by mouth using a special inhaler. It is usually inhaled once a day. Inhale umeclidinium and vilanterol at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use umeclidinium and vilanterol exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.
Do not use umeclidinium and vilanterol inhalation during a sudden COPD attack. Your doctor will prescribe a short-acting (rescue) inhaler to use during COPD attacks.
Umeclidinium and vilanterol inhalation should not be used to treat COPD that is quickly getting worse. Call your doctor or get emergency medical help if your breathing problems worsen, if you have to use your short-acting inhaler to treat attacks of COPD more often, or if your short-acting inhaler does not relieve your symptoms.
Umeclidinium and vilanterol inhalation controls COPD but does not cure it. Continue to use umeclidinium and vilanterol even if you feel well. Do not stop using umeclidinium and vilanterol without talking to your doctor. If you stop using umeclidinium and vilanterol inhalation, your symptoms may get worse.
Before you use umeclidinium and vilanterol inhalation for the first time, ask your doctor, pharmacist, or respiratory therapist to show you how to use the inhaler. Practice using your inhaler while he or she watches.
To use the inhaler, follow these steps:
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
Before using umeclidinium and vilanterol,
Unless your doctor tells you otherwise, continue your normal diet.
Inhale the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not use more than one dose in a day and do not inhale a double dose to make up for a missed one.
Umeclidinium and vilanterol may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
Some side effects can be serious. If you experience any of these symptoms, stop using umeclidinium and vilanterol and call your doctor immediately or get emergency medical treatment:
Umeclidinium and vilanterol may cause other side effects. Call your doctor if you have any unusual problems while using this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( Web Site ) or by phone (1-800-332-1088).
Keep this medication in the foil tray it came in, tightly closed, and out of reach of children. Store it at room temperature and away from sunlight, excess heat and moisture (not in the bathroom). Dispose of the inhaler 6 weeks after you remove it from the foil tray or after every blister has been used (when the dose counter reads 0), whichever comes first.
Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website ( Web Site) for more information if you do not have access to a take-back program.
It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. Web Site
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at Web Site. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
Symptoms of overdose may include the following:
Keep all appointments with your doctor.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
Selected Revisions: February 15, 2017.