Fluticasone Furoate And Vilanterol Trifenatate (Breo Ellipta)

Trade Name : Breo Ellipta

GlaxoSmithKline LLC

POWDER

Strength 10025 ug/1ug/1

FLUTICASONE FUROATE; VILANTEROL TRIFENATATE Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]

Delivery Process

Submit a Request

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

We’ll Get in Touch

Once we review your request, we’ll send you an estimated price for the medicine within 2-5 days.

Confirmation and Payment

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Submit a Request

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Product information is meant for

Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Fluticasone Furoate And Vilanterol Trifenatate (Breo Ellipta) which is also known as Breo Ellipta and Manufactured by GlaxoSmithKline LLC. It is available in strength of 100; 25 ug/1; ug/1 per ml. Read more

Fluticasone Furoate And Vilanterol Trifenatate (Breo Ellipta) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

Inquire directly from our website and get 5% off on any medicine!

About GNH

No data

No data

BREO ELLIPTA is a combination of fluticasone furoate, an inhaled corticosteroid (ICS), and vilanterol, a long-acting beta-adrenergic agonist (LABA), indicated for:
Important limitation of use: Not indicated for relief of acute bronchospasm. (, , )

BREO ELLIPTA should be administered as 1 inhalation once daily by the orally inhaled route only.
BREO ELLIPTA should be used at the same time every day. Do not use BREO ELLIPTA more than 1 time every 24 hours.
After inhalation, the patient should rinse his/her mouth with water without swallowing to help reduce the risk of oropharyngeal candidiasis.
More frequent administration or a greater number of inhalations (more than 1 inhalation daily) of the prescribed strength of BREO ELLIPTA is not recommended as some patients are more likely to experience adverse effects with higher doses. Patients using BREO ELLIPTA should not use additional LABA for any reason. n

Inhalation powder: Disposable light grey and pale blue plastic inhaler containing 2 foil blister strips of powder intended for oral inhalation only. One strip contains fluticasone furoate (100 or 200u00a0mcg per blister), and the other strip contains vilanterol (25u00a0mcg per blister).
Inhalation powder: Inhaler containing 2 foil blister strips of powder formulation for oral inhalation. One strip contains fluticasone furoate 100 or 200 mcg per blister and the other contains vilanterol 25u00a0mcg per blister. ()

The use of BREO ELLIPTA is contraindicated in the following conditions:

No data

Candida albicans

Use of LABA may result in the following:
Systemic and local corticosteroid use may result in the following:
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.
To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

No data

Hepatic impairment: Fluticasone furoate systemic exposure may increase in patients with moderate or severe impairment. Monitor for systemic corticosteroid effects. (, )

No human overdosage data has been reported for BREO ELLIPTA.
BREO ELLIPTA contains both fluticasone furoate and vilanterol; therefore, the risks associated with overdosage for the individual components described below apply to BREO ELLIPTA. Treatment of overdosage consists of discontinuation of BREO ELLIPTA together with institution of appropriate symptomatic and/or supportive therapy. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medicine can produce bronchospasm. Cardiac monitoring is recommended in cases of overdosage.

BREO ELLIPTA 100/25 and BREO ELLIPTA 200/25 are inhalation powders for oral inhalation that contain a combination of fluticasone furoate (an ICS) and vilanterol (a LABA).
One active component of BREO ELLIPTA is fluticasone furoate, a synthetic trifluorinated corticosteroid having the chemical name (6u03b1,11u03b2,16u03b1,17u03b1)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure:
Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is CHFOS. It is practically insoluble in water.
The other active component of BREO ELLIPTA is vilanterol trifenatate, a LABA with the chemical name triphenylacetic acid-4-{(1)-2-[(6-{2-[2,6-dicholorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol (1:1) and the following chemical structure:
Vilanterol trifenatate is a white powder with a molecular weight of 774.8, and the empirical formula is CHClNOu2022CHO. It is practically insoluble in water.
BREO ELLIPTA is a light grey and pale blue plastic inhaler containing 2 foil blister strips. Each blister on one strip contains a white powder mix of micronized fluticasone furoate (100 or 200u00a0mcg) and lactose monohydrate (12.4u00a0mg), and each blister on the other strip contains a white powder mix of micronized vilanterol trifenatate (40u00a0mcg equivalent to 25u00a0mcg of vilanterol), magnesium stearate (125u00a0mcg), and lactose monohydrate (12.34u00a0mg). The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within both blisters is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece.
Under standardized in vitro test conditions, BREO ELLIPTA delivers 92 and 184 mcg of fluticasone furoate and 22 mcg of vilanterol per blister when tested at a flow rate of 60u00a0L/min for 4 seconds.
In adult subjects with obstructive lung disease and severely compromised lung function (COPD with FEV/FVC <70% and FEV <30% predicted or FEV <50% predicted plus chronic respiratory failure), mean peak inspiratory flow through the ELLIPTA inhaler was 66.5u00a0L/min (range: 43.5 to 81.0u00a0L/min).
In adult subjects with severe asthma, mean peak inspiratory flow through the ELLIPTA inhaler was 96.6u00a0L/min (range: 72.4 to 124.6u00a0L/min).
The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.

No data

BREO ELLIPTA
No studies of carcinogenicity, mutagenicity, or impairment of fertility were conducted with BREO ELLIPTA; however, studies are available for the individual components, fluticasone furoate and vilanterol, as described below.
Fluticasone Furoate
Fluticasone furoate produced no treatment-related increases in the incidence of tumors in 2-year inhalation studies in rats and mice at inhaled doses up to 9 and 19u00a0mcg/kg/day, respectively (approximately 0.5 times the MRHDID in adults on a mcg/m basis).
Fluticasone furoate did not induce gene mutation in bacteria or chromosomal damage in a mammalian cell mutation test in mouse lymphoma L5178Y cells inu00a0vitro There was also no evidence of genotoxicity in the inu00a0vivo micronucleus test in rats.
No evidence of impairment of fertility was observed in male and female rats at inhaled fluticasone furoate doses up to 29 and 91u00a0mcg/kg/day, respectively (approximately 3 and 8u00a0times, respectively, the MRHDID based on AUC) .
Vilanterol
In a 2-year carcinogenicity study in mice, vilanterol caused a statistically significant increase in ovarian tubulostromal adenomas in females at an inhalation dose of 29,500 mcg/kg/day (approximately 8,750 times the MRHDID in adults on an AUC basis). No increase in tumors was seen at an inhalation dose of 615 mcg/kg/day (approximately 530 times the MRHDID in adults on an AUC basis).
In a 2-year carcinogenicity study in rats, vilanterol caused statistically significant increases in mesovarian leiomyomas in females and shortening of the latency of pituitary tumors at inhalation doses greater than or equal to 84.4 mcg/kg/day (greater than or equal to approximately 45 times the MRHDID in adults on an AUC basis). No tumors were seen at an inhalation dose of 10.5 mcg/kg/day (approximately 2 times the MRHDID in adults on an AUC basis).
These tumor findings in rodents are similar to those reported previously for other beta-adrenergic agonist drugs. The relevance of these findings to human use is unknown.
Vilanterol tested negative in the following genotoxicity assays: the in vitro Ames assay, in vivo rat bone marrow micronucleus assay, in vivo rat unscheduled DNA synthesis (UDS) assay, and in vitro Syrian hamster embryo (SHE) cell assay. Vilanterol tested equivocal in the in vitro mouse lymphoma assay.
No evidence of impairment of fertility was observed in male and female rats at inhaled vilanterol doses up to 31,500 and 37,100 mcg/kg/day, respectively (approximately 5,490 times the MRHDID based on AUC).

No data

BREO ELLIPTA is supplied as a disposable light grey and pale blue plastic inhaler containing 2 foil strips, each with 30 blisters (or 14 blisters for the institutional pack). One strip contains fluticasone furoate (100 or 200u00a0mcg per blister), and the other strip contains vilanterol (25u00a0mcg per blister). A blister from each strip is used to create 1 dose. The inhaler is packaged within a moisture-protective foil tray with a desiccant and a peelable lid in the following packs:
Store at room temperature between 68u00b0F and 77u00b0F (20u00b0C and 25u00b0C); excursions permitted from 59u00b0F to 86u00b0F (15u00b0C to 30u00b0C) [See USP Controlled Room Temperature]. Store in a dry place away from direct heat or sunlight. Keep out of reach of children.
BREO ELLIPTA should be stored inside the unopened moisture-protective foil tray and only removed from the tray immediately before initial use. Discard BREO ELLIPTA 6 weeks after opening the foil tray or when the counter reads u201c0u201d (after all blisters have been used), whichever comes first. The inhaler is not reusable. Do not attempt to take the inhaler apart.

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
Serious Asthma-Related Events
Inform patients with asthma that LABA when used alone increases the risk of asthma-related hospitalization or asthma-related death. Available data show that when ICS and LABA are used together, such as with BREO ELLIPTA, there is not a significant increase in the risk of these events.
Not for Acute Symptoms
Inform patients that BREO ELLIPTA is not meant to relieve acute symptoms of COPD or asthma and extra doses should not be used for that purpose. Advise patients to treat acute symptoms with an inhaled, short-acting beta-agonist such as albuterol. Provide patients with such medication and instruct them in how it should be used.
Instruct patients to seek medical attention immediately if they experience any of the following:
Tell patients they should not stop therapy with BREO ELLIPTA without physician/provider guidance since symptoms may recur after discontinuation.
Do Not Use Additional Long-acting Beta-agonists
Instruct patients not to use other LABA for COPD and asthma.
Local Effects
Inform patients that localized infections with occurred in the mouth and pharynx in some patients. If oropharyngeal candidiasis develops, treat it with appropriate local or systemic (i.e., oral) antifungal therapy while still continuing therapy with BREO ELLIPTA, but at times therapy with BREO ELLIPTA may need to be temporarily interrupted under close medical supervision. Advise patients to rinse the mouth with water without swallowing after inhalation to help reduce the risk of thrush.
Pneumonia
Patients with COPD have a higher risk of pneumonia; instruct them to contact their healthcare providers if they develop symptoms of pneumonia.
Immunosuppression
Warn patients who are on immunosuppressant doses of corticosteroids to avoid exposure to chickenpox or measles and, if exposed, to consult their physicians without delay. Inform patients of potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex.
Hypercorticism and Adrenal Suppression
Advise patients that BREO ELLIPTA may cause systemic corticosteroid effects of hypercorticism and adrenal suppression. Additionally, inform patients that deaths due to adrenal insufficiency have occurred during and after transfer from systemic corticosteroids. Patients should taper slowly from systemic corticosteroids if transferring to BREO ELLIPTA.
Reduction in Bone Mineral Density
Advise patients who are at an increased risk for decreased BMD that the use of corticosteroids may pose an additional risk.
Glaucoma and Cataracts
Advise patients that long-term use of ICS may increase the risk of some eye problems (cataracts or glaucoma); consider regular eye examinations.
Risks Associated with Beta-agonist Therapy
Inform patients of adverse effects associated with beta-agonists, such as palpitations, chest pain, rapid heart rate, tremor, or nervousness.
Hypersensitivity Reactions, Including Anaphylaxis
Advise patients that hypersensitivity reactions (e.g., anaphylaxis, angioedema, rash, urticaria) may occur after administration of BREO ELLIPTA. Instruct patients to discontinue BREO ELLIPTA if such reactions occur. There have been reports of anaphylactic reactions in patients with severe milk protein allergy after inhalation of other powder medications containing lactose; therefore, patients with severe milk protein allergy should not use BREO ELLIPTA.
Trademarks are owned by or licensed to the GSK group of companies.
BREO ELLIPTA was developed in collaboration with Innoviva.
GlaxoSmithKline
Research Triangle Park, NC 27709
u00a92019 GSK group of companies or its licensor.
BRE:10PI

No data

No data

PRINCIPAL DISPLAY PANEL
NDC 0173-0859-10
BREO ELLIPTA 100/25
(fluticasone furoate 100 mcg and vilanterol 25 mcg inhalation powder)
100 mcg/25 mcg
Rx Only
FOR ORAL INHALATION ONLY
BREO ELLIPTA contains 2 foil strips of 30 blisters each. Each blister on one strip contains 100 mcg of fluticasone furoate and lactose monohydrate. Each blister on the other strip contains 25 mcg of vilanterol, magnesium stearate, and lactose monohydrate.
1 ELLIPTA Inhaler containing 30 doses (60 blisters total)
Trademarks are owned by or licensed to the GSK group of Companies. BREO ELLIPTA was developed in collaboration with Innoviva, Inc.
u00a92018 GSK group of companies or its licensor.

PRINCIPAL DISPLAY PANEL
NDC 0173-0882-10
BREO ELLIPTA 200/25
(fluticasone furoate 200 mcg and vilanterol 25 mcg inhalation powder)
200 mcg/25 mcg
Rx Only
FOR ORAL INHALATION ONLY
BREO ELLIPTA contains 2 foil strips of 30 blisters each. Each blister on one strip contains 200 mcg of fluticasone furoate and lactose monohydrate. Each blister on the other strip contains 25 mcg of vilanterol, magnesium stearate, and lactose monohydrate.
1 ELLIPTA Inhaler containing 30 doses (60 blisters total)
Trademarks are owned by or licensed to the GSK group of Companies. BREO ELLIPTA was developed in collaboration with Innoviva, Inc.
u00a92018 GSK group of companies or its licensor.

Browse Our Services And Processes

Comparator Sourcing for Clinical Trials

GNH India brings over 10 years of experience in Comparator

Name Patient Supply

Today, the exact cause for many rare diseases remains unknown

Validated Cold Chain Shipment

With shifting of pharma industry from synthetic molecules to biologic

Clinical Trials Supply

STOP SOURCING..... START SMART SOURCING...... COME STRAIGHT TO THE SOURCE

Pharmaceutical Contract Manufacturing

GNH Provides Contract Manufacturing services for: Generic Medicines with following

Pricing

PRICING POLICY Terms of sales are typically prepaid, unless otherwise

Disclaimer

Please see the Legal Notice for detailed terms and disclaimers. The Legal Notice governs the use of this Website and by accessing and using this Website you agree to be bound by and accept the Legal Notice.

Browse from other international pharmaceuticals

General

64020 Products

GNH India Brings to over 64036 Product SKUs from India all at 1 place with easy access and global deliveries.

US NDC

71245 Products

GNH India Brings to over 71252 Product SKUs from India all at 1 place with easy access and global deliveries.

Canadian DIN

51046 Products

GNH India Brings to over 51047 Product SKUs from India all at 1 place with easy access and global deliveries.

Swiss Drugs

150 Products

GNH India Brings to over 150 Product SKUs from India all at 1 place with easy access and global deliveries.

NZ Drugs

13296 Products

GNH Brings to over 13298 Product SKUs from India all at 1 place with easy access and global deliveries.

FAQ

Check out our delivery process

Can’t find what
you’re looking for?

Get Price

Fluticasone Furoate And Vilanterol Trifenatate (Breo Ellipta)

Trade Name : Breo Ellipta

POWDER

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what
you’re looking for?

COMPANY

SERVICES

QUICK LINKS

CONTACT US

Fluticasone Furoate And Vilanterol Trifenatate (Breo Ellipta)

Trade Name : Breo Ellipta

POWDER

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what you’re looking for?

COMPANY

SERVICES

QUICK LINKS

CONTACT US

Can’t find what
you’re looking for?