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Fluticasone Furoate/Umeclidinium/Vilanterol is available as an inhalation powder that contains one of the following:

• 100 mcg fluticasone furoate, 62.5 mcg umeclidinium, and 25 mcg vilanterol (100/62.5/25 mcg) per actuation
• 200 mcg fluticasone furoate, 62.5 mcg umeclidinium, and 25 mcg vilanterol (200/62.5/25 mcg) per actuation

Fluticasone Furoate/Umeclidinium/Vilanterol is an ICS / LAMA / LABA and is used for the following:

• Chronic obstructive pulmonary disease (COPD)
• Asthma

Fluticasone Furoate/Umeclidinium/Vilanterol is a combination of three medications used for COPD and asthma that work together to relax and open up the airways in your lungs to help you breathe easier. Fluticasone is an inhaled corticosteroid (ICS). It lowers inflammation (swelling) in your lungs, which helps control COPD and asthma symptoms and helps you breathe easier. Umeclidinium is a long-acting muscarinic antagonist (LAMA). In your lungs, the medication blocks the activity of a natural chemical in your body called acetylcholine. This helps open up your airways in your lungs, which helps you breathe easier. Vilanterol is a long-acting beta-2 agonist (LABA) that helps relax the muscles in your airways and make it easier to breathe.

Fluticasone Furoate/Umeclidinium/Vilanterol is dosed as follows:

• COPD: The maintenance (long-term) dose is 1 inhalation (or puff) by mouth once daily. Each puff contains 100 mcg/62.5 mcg/25 mcg (fluticasone/umeclidinium/vilanterol)
• Asthma: The maintenance dose is 1 inhalation (or puff) by mouth once daily. Each puff contains 100 mcg/62.5 mcg/25 mcg or 200 mcg/62.5 mcg/25 mcg (fluticasone/umeclidinium/vilanterol)

Fluticasone Furoate/Umeclidinium/Vilanterol is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Fluticasone Furoate/Umeclidinium/Vilanterol will not be safe for you to take. Using Fluticasone Furoate/Umeclidinium/Vilanterol for the treatment of sudden COPD or asthma attacks that require intensive measures
Allergy to milk proteins

Common side effects of Fluticasone Furoate/Umeclidinium/Vilanterol:

• Headache
• Back pain
• Abnormal sense of taste
• Diarrhea
• Asthma:
• Common cold or sore throat
• Upper respiratory tract infection
• Headache
• Bronchitis
• Viral respiratory tract infection
• Sinus infection
• Back pain

Serious side effects are rare with Fluticasone Furoate/Umeclidinium/Vilanterol. Contact your healthcare provider immediately if you experience any of the following.

• Sudden breathing problems: sudden shortness of breath, difficulty breathing, coughing, wheezing
• Allergic reactions: hives, swelling (lips, tongue, throat), rash, difficulty breathing, anaphylaxis (allergic reaction)
• Overdose: heart attack, chest pain, fast or abnormal heart rate, dizziness, nervousness, anxiety, headache, tremor, dry mouth, muscle spasms, nausea, tiredness, trouble sleeping (insomnia)

The following medications may interact with Fluticasone Furoate/Umeclidinium/Vilanterol:

• Strong cytochrome P450 3A4 inhibitors (e.g., ketoconazole): Use with caution. May cause systemic corticosteroid and cardiovascular effects
• Monoamine oxidase inhibitors and tricyclic antidepressants: Use with extreme caution. May potentiate effect of vilanterol on cardiovascular system
• Beta-blockers: Use with caution. May block bronchodilatory effects of beta-agonists and produce severe bronchospasm
• Diuretics: Use with caution. Electrocardiographic changes and/or hypokalemia associated with non–potassium-sparing diuretics may worsen with concomitant beta-agonists
• Anticholinergics: May interact additively with concomitantly usedanticholinergic medications. Avoid administration

Various FDA-approved generic manufacturers

It is not known if Fluticasone Furoate/Umeclidinium/Vilanterol can harm your unborn baby. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

• Trelegy Ellipta