Fluticasone Furoate And Vilanterol
Pronunciation: floo-TIK-uh-sone + vye-LAN-ter-ol.
- Generic name
- Fluticasone furoate and Vilanterol
- Brand names
- Breo, Relvar Ellipta, Breo Ellipta, Relvar, Fluvil
- Drug class
- Inhaled corticosteroid and long-acting beta2-adrenergic agonist (LABA) combination
Availability and supply rules vary by country
Trade names by country: United Kingdom
Australia: · Full directory
What Fluticasone furoate and Vilanterol is and how it works
Uses, formulations, monitoring, and supply rules can differ by patient, product, and country. Follow the exact local product information and professional advice.
Mechanism of action: how Fluticasone furoate and Vilanterol works
Fluticasone furoate is a synthetic corticosteroid that inhibits multiple types of inflammatory cells and mediators, reducing airway inflammation. Vilanterol is a selective long-acting beta2-adrenergic agonist (LABA) that relaxes bronchial smooth muscle by stimulating intracellular adenyl cyclase, increasing cyclic AMP levels. The combination provides both anti-inflammatory and bronchodilatory effects, improving airflow and reducing exacerbations in asthma and COPD. (1)
What Fluticasone furoate and Vilanterol is used for
Maintenance treatment of asthma
Maintenance treatment of asthma (2)
Maintenance treatment of chronic obstructive pulmonary disease (COPD)
Maintenance treatment of chronic obstructive pulmonary disease (COPD) (2)
Reducing COPD exacerbations
Reducing COPD exacerbations (2)
Maintenance treatment of asthma in children 5 years and older
The FDA label extends the asthma indication down to age 5 using the lowest available strength (50 mcg/25 mcg); this pediatric detail and dose strength were missing from the DB record, which stated a general '18 years' pediatric restriction inconsistent with its own administration text (which already correctly mentioned ages 12+). (2)
Before taking Fluticasone furoate and Vilanterol
Do not take / not appropriate for
- do not use in patients with a severe hypersensitivity to milk proteins, since the inhaler powder contains lactose. (Contraindication) (2)
Tell your clinician about
(2)How to take Fluticasone furoate and Vilanterol
- General Instructions: Use Fluticasone + Vilanterol inhaler exactly as prescribed, usually once daily at the same time each day. Do not use more than the recommended dose.. Adult Dosing: For COPD: 100 mcg/25 mcg or 200 mcg/25 mcg (fluticasone/vilanterol) inhaled once daily. For asthma: 100 mcg/25 mcg or 200 mcg/25 mcg inhaled once daily, as directed by your doctor.. Pediatric Dosing: Not recommended for children for COPD (COPD indication is adults only). For asthma: ages 12 and older, 100 mcg/25 mcg once daily; ages 5-11, 50 mcg/25 mcg once daily (the lowest available strength). Safety and efficacy in children under 5 have not been established.. Administration: Inhale the powder deeply through the mouthpiece. Do not shake the inhaler. Rinse your mouth with water (do not swallow) after each use to reduce the risk of oral thrush.. When To Stop: Do not stop using this medication suddenly without your doctor's advice, as symptoms may worsen. Your doctor will guide you on how to discontinue if needed.. Storage: Store at room temperature, away from moisture, heat, and direct sunlight. Keep the inhaler in its original packaging until ready to use.
- This page does not provide a dose calculator. Dosing must follow the prescriber, pharmacist, or product label.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (2)
Missed dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose. Do not take two doses at once.
Overdose
In case of overdose, seek emergency medical attention. Symptoms may include chest pain, fast or irregular heartbeat, tremors, or severe headache. Supportive care is recommended. (2)
Side effects
Side effects and their urgency vary; report severe, persistent, or concerning symptoms to a healthcare professional.
Headache
Incidence: Reported in the clinician-authored database; frequency not established
Nasopharyngitis
Incidence: Reported in the clinician-authored database; frequency not established
Upper respiratory tract infection
Incidence: Reported in the clinician-authored database; frequency not established
Oral candidiasis (thrush)
Incidence: Reported in the clinician-authored database; frequency not established
Bronchospasm
Incidence: Reported in the clinician-authored database; frequency not established
Pneumonia
Incidence: Reported in the clinician-authored database; frequency not established
Increased blood pressure
Incidence: Reported in the clinician-authored database; frequency not established
Signs of pneumonia: increased sputum production, fever, chills, or worsening respiratory symptoms
(2)Palpitations, chest pain, or a rapid/irregular heartbeat
(2)Eye pain or vision changes (possible glaucoma or cataracts with prolonged use)
(2)In children: signs of slowed growth — routine growth monitoring is recommended by the treating clinician
(2)Serious warnings
Not for relief of acute bronchospasm or asthma attacks — serious
Symptoms: Not for relief of acute bronchospasm or asthma attacks. Long-acting beta2-agonists (LABAs) such as vilanterol are associated, as a drug class, with an increased risk of asthma-related death when used as monotherapy without an inhaled corticosteroid; Breo Ellipta already combines vilanterol with the corticosteroid fluticasone furoate, but this class-wide LABA safety information still applies to how it must be used (regularly, as prescribed, alongside — never in place of — any other prescribed asthma controller). Risk of oral thrush; rinse mouth after use. May cause paradoxical bronchospasm (worsening breathing). Long-term use may affect bone density or cause adrenal suppression.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
Contraindications recorded in the clinician database — serious
Symptoms: Contraindications recorded in the clinician database: Contraindications include hypersensitivity to fluticasone, vilanterol, or milk proteins. Use with caution in patients with cardiovascular disorders, convulsive disorders, thyrotoxicosis, diabetes, active or latent tuberculosis, untreated infections, and ocular herpes simplex. Not for primary treatment of acute asthma or COPD exacerbations.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
The FDA label adds further warnings beyond the clinician database — serious
Symptoms: The FDA label adds further warnings beyond the clinician database: increased pneumonia risk has been observed in COPD patients; cardiovascular effects can occur with the beta-agonist component (report palpitations, chest pain, or rapid heartbeat); prolonged use of the inhaled corticosteroid component can be associated with glaucoma, cataracts, and reduced bone mineral density; growth velocity may be reduced in pediatric patients, so growth should be monitored regularly by the treating clinician; hyperglycemia and hypokalemia have been reported; and if transferring from a systemic (oral/injectable) corticosteroid, adrenal insufficiency can occur during and after the transfer, requiring careful clinician-directed tapering.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
Interactions
| Medicine or test | Effect | Action |
|---|---|---|
| Recorded interactions | Fluticasone + Vilanterol may interact with strong CYP3A4 inhibitors (such as ketoconazole, ritonavir), other long-acting beta-agonists, and certain antifungal or antiviral medications. These interactions can increase the risk of side effects or reduce effectiveness. Always inform your healthcare provider about all medicines and supplements you are taking. | (1) |
| Beta-blockers | May block the bronchodilating effect of vilanterol and can cause severe bronchospasm; if a beta-blocker is medically necessary, a cardioselective one is generally preferred, decided by the treating clinician. | (2) |
| MAOIs and tricyclic antidepressants | Use with extreme caution; these can potentiate the cardiovascular effects of vilanterol. | (2) |
| Non-potassium-sparing diuretics | May worsen ECG changes and low potassium (hypokalemia) caused by beta-agonists; use with caution and clinician monitoring. | (2) |
Pregnancy, breastfeeding, kidney/liver function, age
Pregnancy
The FDA label states there are insufficient human data on Breo Ellipta or its individual components in pregnancy to establish a drug-associated risk; animal studies did not show fetal structural abnormalities at clinically relevant exposures. Poorly controlled asthma during pregnancy increases risks to both mother and baby, so treatment is generally continued under close clinician monitoring rather than stopped — any change in therapy during pregnancy should be discussed with your prescriber. (2)
Breastfeeding
Low concentrations of inhaled corticosteroids have been detected in human milk with related products. The FDA label advises weighing the benefits of breastfeeding against the mother's clinical need for the medicine, in discussion with your healthcare provider. (2)
Children
Frequency: Not applicable.. Weight Based: Not recommended for pediatric use for COPD (adults only). For asthma: approved from age 5 (50 mcg/25 mcg strength for ages 5-11; 100 mcg/25 mcg for ages 12 and older). Max Daily Dose: One inhalation daily. Max Single Dose: One inhalation. Age Restrictions: Safety and effectiveness in asthma have not been established under age 5. -- CORRECTS the DB record, which stated a general 'safety not established in children under 18 years,' inconsistent with its own administration text (already correct for ages 12+) and omitting the FDA-approved 50/25 mcg strength for ages 5-11. (2)
Renal_impairment
Renal impairment: the FDA label states no dosage adjustment is needed; no clinically significant increase in exposure was seen in severe renal impairment. Hepatic impairment: fluticasone furoate exposure may increase up to 3-fold in moderate-to-severe hepatic impairment (vilanterol exposure is not significantly affected); use with caution and monitor for corticosteroid-related side effects. (2)
Hepatic_impairment
Renal impairment: the FDA label states no dosage adjustment is needed; no clinically significant increase in exposure was seen in severe renal impairment. Hepatic impairment: fluticasone furoate exposure may increase up to 3-fold in moderate-to-severe hepatic impairment (vilanterol exposure is not significantly affected); use with caution and monitor for corticosteroid-related side effects. (2)
Monitoring
(2)Storage
Store at room temperature, away from moisture, heat, and direct sunlight. Keep the inhaler in its original sealed packaging until ready to use, and discard as directed once the dose counter reaches zero.
Professional information
Clinician-facing context only. This section does not replace current product labeling.
General
Indication: Maintenance treatment of asthma / COPD
Dose summary: COPD (adults): 100/25 mcg once daily. Asthma (adults/12+): 100/25 mcg or 200/25 mcg once daily. Asthma (ages 5-11): 50/25 mcg once daily — the lowest available strength, not previously recorded in the DB.
Renal context: No dosage adjustment needed for renal impairment. Hepatic impairment: fluticasone furoate exposure may increase up to 3-fold in moderate-to-severe impairment; monitor for corticosteroid-related side effects. (1) (2)
Frequently asked questions
What is Fluticasone + Vilanterol (Breo Ellipta) used for?
It is used for long-term control of asthma and COPD symptoms, including chronic bronchitis and emphysema. It helps reduce inflammation and keep airways open.
How quickly does Breo Ellipta start working?
Some patients may notice improvement in breathing within a few days, but full benefits may take up to a week or longer. It is not for immediate relief of acute symptoms.
Can I use Breo Ellipta if I am pregnant or breastfeeding?
Discuss with your doctor. The safety of this medication during pregnancy and breastfeeding is not fully established. Use only if the potential benefit justifies the potential risk.
What should I do if I develop oral thrush?
Contact your healthcare provider. Rinsing your mouth after each use helps prevent this. If thrush develops, antifungal treatment may be needed.
Is Breo Ellipta a rescue inhaler?
No, it is not a rescue inhaler. It is for daily maintenance therapy. For sudden symptoms, use your prescribed rescue inhaler (such as albuterol).
Can children use Fluticasone + Vilanterol?
For asthma, it is FDA-approved from age 5: the 50 mcg/25 mcg strength for ages 5-11, and the 100 mcg/25 mcg strength for ages 12 and older. It is not approved for COPD in children (COPD treatment with this medicine is for adults only). Safety in children under 5 has not been established.
What should I do if I miss a dose?
Take the missed dose as soon as you remember, unless it is almost time for your next dose. Do not double up. Continue with your regular schedule.
What happens if I take too much Fluticasone + Vilanterol (Breo Ellipta)?
Taking too much Fluticasone + Vilanterol (Breo Ellipta) can lead to symptoms such as chest pain, rapid heart rate, tremors, and nervousness due to the vilanterol component, and potential systemic corticosteroid effects from fluticasone. If an overdose is suspected, seek emergency medical attention immediately. Do not exceed the prescribed dosage.
Can I drink alcohol while taking Fluticasone + Vilanterol (Breo Ellipta)?
While there are no specific contraindications for alcohol consumption with Fluticasone + Vilanterol (Breo Ellipta), alcohol can sometimes exacerbate respiratory symptoms or interact with other medications you might be taking. It is generally advisable to consume alcohol in moderation or discuss its use with your healthcare provider to ensure it does not interfere with your treatment or overall health.
Is Fluticasone + Vilanterol (Breo Ellipta) safe during pregnancy?
Fluticasone + Vilanterol (Breo Ellipta) is classified under a pregnancy category that requires careful consideration. The safety of this medication during pregnancy has not been definitively established. It is crucial to consult your doctor if you are pregnant, planning to become pregnant, or breastfeeding to weigh the potential benefits against any risks to the fetus or infant.
What is the mechanism of action of Fluticasone furoate and Vilanterol?
Fluticasone furoate is a synthetic corticosteroid that inhibits multiple types of inflammatory cells and mediators, reducing airway inflammation. Vilanterol is a selective long-acting beta2-adrenergic agonist (LABA) that relaxes bronchial smooth muscle by stimulating intracellular adenyl cyclase, increasing cyclic AMP levels. The combination provides both anti-inflammatory and bronchodilatory effects, improving airflow and reducing exacerbations in asthma and COPD. (1)
What is the generic name of Fluticasone Furoate And Vilanterol?
The generic name is Fluticasone furoate and Vilanterol. It is sold under brand names including Breo, Relvar Ellipta, Breo Ellipta, Relvar, Fluvil.
What class of drug is Fluticasone furoate and Vilanterol?
Fluticasone Furoate And Vilanterol is classed as: Inhaled corticosteroid and long-acting beta2-adrenergic agonist (LABA) combination.
References
- Fluticasone + Vilanterol (Breo Ellipta) Clinician RecordMedGuideGlobal · Global · accessed 2026-08-06 · source 1
- BREO ELLIPTA (fluticasone furoate and vilanterol) full prescribing informationU.S. Food and Drug Administration (DailyMed) · United States · accessed 2026-08-06 · source 2
- FLUTICASONE FUROATE AND VILANTEROL POWDER [PRASCO LABORATORIES] — US prescribing information (DailyMed SPL)U.S. National Library of Medicine (DailyMed) · US · accessed 2026-08-14 · source 3
- Fluticasone Furoate and Vilanterol — FDA approval record (Drugs@FDA NDA204275)U.S. Food and Drug Administration · US · accessed 2026-08-14 · source 4
Brand names by country
Single-ingredient Fluticasone furoate and Vilanterol names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
United Kingdom
- Relvar Ellipta 92 micrograms/22 micrograms inhalation powder, pre-dispensed92 micrograms/22 micrograms · GlaxoSmithKline UK
- Relvar Ellipta 184 micrograms/22 micrograms inhalation powder, pre-dispensed184 micrograms/22 micrograms · GlaxoSmithKline UK