Fluticasone, umeclidinium, and vilanterol

Fluticasone, umeclidinium, and vilanterol is a combination medicine used to prevent airflow blockage and reduce flare-ups in adults with COPD (chronic obstructive pulmonary disease), which includes bronchitis and emphysema.

Fluticasone, umeclidinium, and vilanterol is also used to prevent and control asthma symptoms in adults.

Fluticasone, umeclidinium, and vilanterol is not for treating an asthma or bronchospasm attack.

Using vilanterol alone may increase the risk of death for people with asthma. However, this risk does not increase when vilanterol is used as part of a combination product with fluticasone and umeclidinium.

Fluticasone, umeclidinium, and vilanterol may also be used for purposes not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed. Using this medicine improperly can cause death or serious side effects on the heart.

Use the medicine at the same time each day, and not more than once in a 24-hour period.

Read and follow all patient instructions provided with the inhaler device. Ask your doctor or pharmacist if you do not understand these instructions.

To prevent a yeast infection in your mouth, rinse with water (but do not swallow) after using this medicine.

Fluticasone, umeclidinium, and vilanterol is not a rescue medicine for asthma or bronchospasm attacks. Use only fast-acting inhalation medicine for an attack. Seek medical attention if your breathing problems get worse quickly, or if you think your medications are not working as well.

Your dose needs may change due to surgery, illness, stress, or worsened COPD. Do not change your dose or dosing schedule without your doctor's advice.

You may need frequent medical 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 you are 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.

Fluticasone, umeclidinium, and vilanterol is not a rescue medicine for asthma or bronchospasm attacks. Use only fast-acting inhalation medicine for an attack. Seek medical attention if your breathing problems get worse quickly, or if you think your medications are not working as well.

You should not use this medicine if you are allergic to fluticasone, umeclidinium, vilanterol, or milk proteins.

Tell your doctor if you have ever had:

• heart disease, high blood pressure;
• a seizure;
• a weak immune system;
• any type of bacterial, fungal, or viral infection, or an infection caused by parasites;
• liver disease;
• glaucoma, cataracts, or other vision problems;
• diabetes (or ketoacidosis);
• osteoporosis;
• a thyroid disorder; or
• an enlarged prostate, bladder obstruction, or urination problems.

If you have been using an oral steroid medication, you should not stop using it suddenly. Follow your doctor's instructions about tapering your dose.

Tell your doctor if you are pregnant or breastfeeding.

This medicine is not approved for use by anyone younger than 18 years old.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Fluticasone, umeclidinium, and vilanterol may cause serious side effects. Call your doctor right away if you have:

• tremors, nervousness, chest pain, fast or pounding heartbeats;
• sores or white patches in your mouth and throat, pain when swallowing;
• wheezing, choking, or other breathing problems after using this medicine;
• painful or difficult urination;
• blurred vision, tunnel vision, eye pain or redness, or seeing halos around lights;
• a lung infection--fever, chills, cough with mucus, feeling short of breath;
• high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor;
• low potassium level--leg cramps, constipation, irregular heartbeats, fluttering in your chest, numbness or tingling, muscle weakness or limp feeling; or
• signs of a hormonal disorder--tiredness or weakness, feeling light-headed, nausea, vomiting.

Common side effects of fluticasone, umeclidinium, and vilanterol may include:

• cold or flu symptoms such as runny or stuffy nose, sinus pain, sore throat, cough, chest tightness;
• a lung infection;
• nausea, vomiting, constipation, diarrhea;
• urination problems;
• joint pain;
• mouth sores, hoarse voice;
• headache, back pain; or
• mouth pain, 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.

Usual Adult Dose for Chronic Obstructive Pulmonary Disease -- Maintenance:

1 inhalation (fluticasone/umeclidinium/vilanterol 100 mcg-62.5 mcg-25 mcg) orally once a dayMaximum dose: 1 inhalation every 24 hoursComments:-More frequent administration or a greater number of inhalations than the recommended dose should not be used, as adverse effects are more likely to occur with higher doses.-Use with caution when transferring from systemically active corticosteroid therapy.-Patients requiring oral corticosteroids should be weaned slowly from systemic corticosteroid use after transferring to this drug.Uses: -Long-term maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema-Reduce exacerbations of COPD in patients with a history of exacerbations.

Usual Adult Dose for Asthma -- Maintenance:

1 inhalation (fluticasone/umeclidinium/vilanterol 100 mcg-62.5 mcg-25 mcg or 200 mcg-62.5 mcg-25 mcg) orally once a dayMaximum dose: 1 inhalation (fluticasone/umeclidinium/vilanterol 200 mcg-62.5 mcg-25 mcg) every 24 hoursComments:-When choosing starting dose, consider disease severity, previous asthma therapy (including inhaled corticosteroid use), current symptom control and risk of future exacerbations.-Patients with inadequate response to fluticasone/umeclidinium/vilanterol 100 mcg-62.5 mcg-25 mcg may gain additional improvement with fluticasone/umeclidinium/vilanterol 200 mcg-62.5 mcg-25 mcg.-Consider reevaluation and other therapies if response to fluticasone/umeclidinium/vilanterol 200 mcg-62.5 mcg-25 mcg is inadequate.-If asthma symptoms arise between doses, use and inhaled short-acting beta-2 agonist (e.g. albuterol) for immediate relief.

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

Do not use more than 1 inhalation in a single day.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222.

Signs of an overdose may include chest pain, a fast heart rate, and feeling shaky or short of breath.

Do not use a second inhaled bronchodilator that has vilanterol or a similar medicine (like formoterol, arformoterol, indacaterol, olodaterol, or salmeterol).

Stay away from people who are sick or have infections. Contact your doctor for preventive treatment if you come into contact with chickenpox or measles. These illnesses can be serious or even deadly for those taking a medicine that contains fluticasone (a steroid).

Tell your doctor about all your other medicines, especially:

• atropine;
• antifungal or antiviral medicine;
• medicine to treat depression, anxiety, mood disorders, or mental illness;
• cold or allergy medicine (Benadryl and others);
• medicine to treat Parkinson's disease;
• medicine to treat stomach problems, motion sickness, or irritable bowel syndrome;
• medicine to treat overactive bladder; or
• other bronchodilator medication.

This list is not complete. Other drugs may affect fluticasone, umeclidinium, and vilanterol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.