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Fluticasone / Umeclidinium / Vilanterol Dosage

Medically reviewed by Drugs.com. Last updated on Nov 3, 2020.

Applies to the following strengths: 100 mcg-62.5 mcg-25 mcg/inh; 200 mcg-62.5 mcg-25 mcg/inh

Usual Adult Dose for Chronic Obstructive Pulmonary Disease - Maintenance

1 inhalation (fluticasone/umeclidinium/vilanterol 100 mcg-62.5 mcg-25 mcg) orally once a day
Maximum dose: 1 inhalation every 24 hours

Comments:
-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 day
Maximum dose: 1 inhalation (fluticasone/umeclidinium/vilanterol 200 mcg-62.5 mcg-25 mcg) every 24 hours

Comments:
-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.

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

Mild to moderate liver dysfunction: No adjustment recommended.
Severe liver dysfunction: Safety has not been evaluated.

Precautions

US FDA requires a medication guide to assure safe use. For additional information: www.fda.gov/drugs/drug-safety-and-availability/medication-guides

CONTRAINDICATIONS:
-Hypersensitivity to any of the ingredients
-Primary treatment of status asthmaticus or other acute episodes of COPD or asthma where intensive measures are required
-Severe hypersensitivity to milk proteins


Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
-For oral inhalation only.
-Use at the same time every day.
-After each inhalation, rinse mouth with water without swallowing to reduce the risk of oropharyngeal candidiasis.
-The inhaler is not reusable. Do not attempt to take the inhaler apart.
-Discard 6 weeks after opening the foil tray or when the counter reads zero, whichever comes first.
-The manufacturer's product information should be consulted for instruction on how to use the inhaler device.

Storage requirements:
-Store at room temperature between 68F and 77F (20C and 25C).
-Store in the unopened protective foil tray in a dry place away from direct heat or sunlight, and only open when ready to use.

Limitations of use: This drug is not indicated for the relief of acute bronchospasm or for the treatment of asthma.

Patient advice:
-Consult a healthcare provider immediately if signs and symptoms of acute narrow-angle glaucoma (e.g., eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion and corneal edema) develop.
-Consult a healthcare provider immediately if any signs or symptoms of urinary retention (e.g., difficulty passing urine, painful urination) develop.
-Patients should not use other medicines containing a long-acting beta2 agonists (LABA).
-Patients should carry a warning card indicating their need of supplementary systemic corticosteroids during periods of stress or a severe COPD exacerbation.

Frequently asked questions

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.