Fixed-dose combination
Fluticasone furoate and Vilanterol is a fixed-dose combination of a corticosteroid and a beta2-adrenergic agonist indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), among other approved uses. MedsAcross supplies Fluticasone furoate and Vilanterol for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
Fluticasone Furoate/Vilanterol ELLIPTA is a combination of fluticasone furoate, a corticosteroid, and vilanterol, a long‑acting beta 2 -adrenergic agonist (LABA), indicated for: • the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). • the maintenance treatment of asthma in patients aged 5 years and older. Limitations of Use: Not indicated for relief of acute bronchospasm.
Source: US FDA prescribing information
Fluticasone Furoate/Vilanterol ELLIPTA Fluticasone Furoate/Vilanterol ELLIPTA contains both fluticasone furoate and vilanterol. The mechanisms of action described below for the individual components apply to Fluticasone Furoate/Vilanterol ELLIPTA. These drugs represent 2 different classes of medications (an ICS and a LABA), each having different effects on clinical and physiological indices. Fluticasone Furoate Fluticasone furoate is a synthetic trifluorinated corticosteroid with anti-inflammatory activity. Fluticasone furoate has been shown in vitro to exhibit a binding affinity for the human glucocorticoid receptor that is approximately 29.9 times that of dexamethasone and 1.7 times that of fluticasone propionate. The clinical relevance of these findings is unknown. The precise mechanism through which fluticasone furoate affects COPD and asthma symptoms is not known.
Source: US FDA prescribing information
• For oral inhalation only. • Maintenance treatment of COPD: 1 actuation of Fluticasone Furoate/Vilanterol ELLIPTA 100/25 mcg once daily administered by oral inhalation. • Maintenance treatment of asthma in adult patients aged 18 years and older: 1 actuation of Fluticasone Furoate/Vilanterol ELLIPTA 100/25 mcg or Fluticasone Furoate/Vilanterol ELLIPTA 200/25 mcg once daily administered by oral inhalation. • Maintenance treatment of asthma in pediatric patients aged 12 to 17 years: 1 actuation of Fluticasone Furoate/Vilanterol ELLIPTA 100/25 mcg once daily administered by oral inhalation. • Maintenance treatment of asthma in pediatric patients aged 5 to 11 years: 1 actuation of fluticasone furoate/vilanterol ELLIPTA 50/25 mcg once daily administered by oral inhalation.
Source: US FDA prescribing information
Fluticasone Furoate/Vilanterol ELLIPTA is contraindicated in the following conditions: • Primary treatment of status asthmaticus or other acute episodes of COPD or asthma where intensive measures are required. • Severe hypersensitivity to milk proteins or demonstrated hypersensitivity to fluticasone furoate, vilanterol, or any of the excipients. • Primary treatment of status asthmaticus or acute episodes of COPD or asthma requiring intensive measures. • Severe hypersensitivity to milk proteins or any ingredients.
Source: US FDA prescribing information
• LABA monotherapy increases the risk of serious asthma-related events. • Do not initiate in acutely deteriorating COPD or asthma. Do not use to treat acute symptoms. • Do not use in combination with additional therapy containing a LABA because of risk of overdose. • Candida albicans infection of the mouth and pharynx may occur. Monitor patients periodically. Advise the patient to rinse his/her mouth with water without swallowing after inhalation to help reduce the risk. • Increased risk of pneumonia in patients with COPD. Monitor patients for signs and symptoms of pneumonia. • Potential worsening of infections (e.g., existing tuberculosis, fungal, bacterial, viral, or parasitic infections, ocular herpes simplex). Use with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients.
Source: US FDA prescribing information
The following clinically significant adverse reactions are described elsewhere in labeling: • Serious Asthma-Related Events – Hospitalizations, Intubations, Death • Oropharyngeal Candidiasis • Pneumonia • Immunosuppression and Risk of Infections • Hypercorticism and Adrenal Suppression • Paradoxical Bronchospasm • Cardiovascular Effects • Reduction in Bone Mineral Density • Growth Effects • Glaucoma and Cataracts Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Source: US FDA prescribing information
• 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.
Source: US FDA prescribing information
Store at room temperature between 68°F and 77°F (20°C and 25°C), excursions permitted from 59°F to 86°F (15°C to 30°C). Store in a dry place away from direct heat or sunlight. Fluticasone Furoate/Vilanterol ELLIPTA should be stored inside the unopened moisture‑protective foil tray and only removed from the tray immediately before initial use.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
5 presentations of Fluticasone furoate and Vilanterol, sorted by availability.
| Medicine | Active ingredient | Manufacturer | Register | Availability |
|---|---|---|---|---|
| Breo Ellipta 100 mcg/25 mcg inhalation powderInhalation | Fluticasone furoate and Vilanterol | GlaxoSmithKline | US FDA | Available on request |
| Breo Ellipta 200 mcg/25 mcg inhalation powderInhalation | Fluticasone furoate and Vilanterol | GlaxoSmithKline | US FDA | Available on request |
| Breo Ellipta 50 mcg/25 mcg inhalation powderInhalation | Fluticasone furoate and Vilanterol | GlaxoSmithKline | US FDA | Available on request |
| Fluticasone furoate and Vilanterol 100 mcg/25 mcg inhalation powderInhalationGeneric name | Fluticasone furoate and Vilanterol | — | US FDA | Available on request |
| Fluticasone furoate and Vilanterol 200 mcg/25 mcg inhalation powderInhalationGeneric name | Fluticasone furoate and Vilanterol | — | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 5 presentations of Fluticasone furoate and Vilanterol and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Fluticasone furoate and Vilanterol, including Breo Ellipta.
Yes. The US FDA first approved Fluticasone furoate and Vilanterol on 10 May 2013, according to Drugs@FDA.
Yes. Fluticasone furoate and Vilanterol has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Fluticasone furoate and Vilanterol is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Fluticasone furoate and Vilanterol is classified under ATC code R03AK10 (Fluticasone furoate and Vilanterol).
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