Fluticasone, umeclidinium, and vilanterol

Generic name: Fluticasone, Umeclidinium, And Vilanterol
Brand names: Trelegy Ellipta
Dosage form: inhalation powder (100 mcg-62.5 mcg-25 mcg/inh; 200 mcg-62.5 mcg-25 mcg/inh)
Drug class: Bronchodilator combinations

Usage of Fluticasone, umeclidinium, and vilanterol

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

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

fluticasone, umeclidinium, and vilanterol is not for use in treating an asthma or bronchospasm attack.

Vilanterol when used alone may increase the risk of death in people with asthma. However, this risk is not increased when vilanterol is used in a combination product with fluticasone and umeclidinium.

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

Fluticasone, umeclidinium, and vilanterol side effects

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 at once 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.

Before taking Fluticasone, umeclidinium, and vilanterol

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.

Relate drugs

How to use Fluticasone, umeclidinium, and vilanterol

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.

Warnings

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.

What other drugs will affect Fluticasone, umeclidinium, and vilanterol

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.

Disclaimer

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