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Fixed-dose combination

Fluticasone propionate and Salmeterol

Also known as fluticasone propionate, salmeterol xinafoate
Available on requestRespiratory
Presentations
24
Brands
6
Manufacturers
5
Available from stock
0

Fluticasone propionate and Salmeterol is a fixed-dose combination of a corticosteroid and a beta2-adrenergic agonist indicated for twice-daily treatment of asthma in patients aged 4 years and older, among other approved uses. MedsAcross supplies Fluticasone propionate and Salmeterol 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

Key facts

Pharmacological class
Beta2-Adrenergic Agonist, Corticosteroid, Adrenergic beta2-Agonists, Corticosteroid Hormone Receptor Agonists
ATC classification
R03AK06 Fluticasone propionate and Salmeterol · Asthma and COPD medicines, subgroup R03A, subgroup R03AK
US FDA first approval
24 August 2000
EU status
Authorised
Orphan designation
No
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Inhalation
Dosage forms
Inhalation powder, Inhaler
Fixed-dose combination of
Fluticasone propionate, Salmeterol

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

ADVAIR DISKUS is a combination product containing a corticosteroid and a long-acting beta 2 -adrenergic agonist (LABA) indicated for: • Twice-daily treatment of asthma in patients aged 4 years and older. • Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). Important limitation of use: Not indicated for relief of acute bronchospasm.

Source: US FDA prescribing information

How it works

ADVAIR DISKUS ADVAIR DISKUS contains both fluticasone propionate and salmeterol. The mechanisms of action described below for the individual components apply to ADVAIR DISKUS. These drugs represent 2 different classes of medications (a synthetic corticosteroid and a LABA) that have different effects on clinical, physiologic, and inflammatory indices. Fluticasone Propionate Fluticasone propionate is a synthetic trifluorinated corticosteroid with anti-inflammatory activity. Fluticasone propionate has been shown in vitro to exhibit a binding affinity for the human glucocorticoid receptor that is 18 times that of dexamethasone, almost twice that of beclomethasone-17-monopropionate (BMP), the active metabolite of beclomethasone dipropionate, and over 3 times that of budesonide. Data from the McKenzie vasoconstrictor assay in man are consistent with these results.

Source: US FDA prescribing information

Dosing overview

ADVAIR DISKUS should be administered as 1 inhalation twice daily by the orally inhaled route only. 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 twice daily) of the prescribed strength of ADVAIR DISKUS is not recommended as some patients are more likely to experience adverse effects with higher doses of salmeterol. Patients using ADVAIR DISKUS should not use additional LABA for any reason. • For oral inhalation only. • Treatment of asthma in patients aged 12 years and older: 1 inhalation of ADVAIR DISKUS 100/50, ADVAIR DISKUS 250/50, or ADVAIR DISKUS 500/50 twice daily. Starting dosage is based on asthma severity.

Source: US FDA prescribing information

Contraindications

The use of ADVAIR DISKUS is contraindicated in the following conditions: • Primary treatment of status asthmaticus or other acute episodes of asthma or COPD where intensive measures are required. • Severe hypersensitivity to milk proteins or demonstrated hypersensitivity to fluticasone propionate, salmeterol, or any of the excipients. • Primary treatment of status asthmaticus or acute episodes of asthma or COPD requiring intensive measures. • Severe hypersensitivity to milk proteins or demonstrated hypersensitivity to fluticasone propionate, salmeterol, or any of the excipients.

Source: US FDA prescribing information

Warnings and precautions

• LABA monotherapy increases the risk of serious asthma-related events. • Do not initiate in acutely deteriorating asthma or COPD. Do not use to treat acute symptoms. • Do not use in combination with an additional medicine 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

Side effects

Use of LABA may result in the following: • Serious asthma-related events – hospitalizations, intubations, death • Cardiovascular and central nervous system effects Systemic and local corticosteroid use may result in the following: • Candida albicans infection • Pneumonia in patients with COPD • Immunosuppression • Hypercorticism and adrenal suppression • 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

Interactions

ADVAIR DISKUS has been used concomitantly with other drugs, including short-acting beta 2 -agonists, methylxanthines, and intranasal corticosteroids, commonly used in patients with asthma or COPD without adverse drug reactions. No formal drug interaction trials have been performed with ADVAIR DISKUS. • Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir, ketoconazole): Use not recommended. May increase risk of systemic corticosteroid and cardiovascular effects. • Monoamine oxidase inhibitors and tricyclic antidepressants: Use with extreme caution. May potentiate effect of salmeterol on vascular system. • Beta-blockers: Use with caution. May block bronchodilatory effects of beta-agonists and produce severe bronchospasm. • Diuretics: Use with caution.

Source: US FDA prescribing information

Storage

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. ADVAIR DISKUS should be stored inside the unopened moisture-protective foil pouch and only removed from the pouch 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.

All presentations

24 presentations of Fluticasone propionate and Salmeterol, sorted by availability.

MedicineActive ingredientManufacturerRegisterAvailability
Fluticasone propionate and Salmeterol 100 mcg/50 mcg inhalation powderInhalationGeneric nameFluticasone propionate and Salmeterol—US FDAAvailable on request
Fluticasone propionate and Salmeterol 250 mcg/50 mcg inhalation powderInhalationGeneric nameFluticasone propionate and Salmeterol—US FDAAvailable on request
Fluticasone Propionate and Salmeterol DISKUS 250 mcg/50 mcg inhalation powderInhalationFluticasone propionate and SalmeterolA-S Medication SolutionsUS FDAAvailable on request
Fluticasone Propionate and Salmeterol DISKUS 100 mcg/50 mcg inhalation powderInhalationFluticasone propionate and SalmeterolA-S Medication SolutionsUS FDAAvailable on request
Advair HFA 115 mcg/21 mcg inhalerInhalationFluticasone propionate and SalmeterolGlaxoSmithKlineUS FDAAvailable on request
Fluticasone propionate and Salmeterol 113 mcg/14 mcg inhalation powderInhalationGeneric nameFluticasone propionate and Salmeterol—US FDAAvailable on request
Fluticasone propionate and Salmeterol 232 mcg/14 mcg inhalation powderInhalationGeneric nameFluticasone propionate and Salmeterol—US FDAAvailable on request
Fluticasone propionate and Salmeterol 500 mcg/50 mcg inhalation powderInhalationGeneric nameFluticasone propionate and Salmeterol—US FDAAvailable on request
Fluticasone propionate and Salmeterol 55 mcg/14 mcg inhalation powderInhalationGeneric nameFluticasone propionate and Salmeterol—US FDAAvailable on request
Fluticasone Propionate and Salmeterol DISKUS 500 mcg/50 mcg inhalation powderInhalationFluticasone propionate and SalmeterolA-S Medication SolutionsUS FDAAvailable on request
Advair Diskus 100 mcg/50 mcg inhalation powderInhalationFluticasone propionate and SalmeterolGlaxoSmithKlineUS FDAAvailable on request
Advair Diskus 250 mcg/50 mcg inhalation powderInhalationFluticasone propionate and SalmeterolGlaxoSmithKlineUS FDAAvailable on request
Advair Diskus 500 mcg/50 mcg inhalation powderInhalationFluticasone propionate and SalmeterolGlaxoSmithKlineUS FDAAvailable on request
Wixela Inhub 250 mcg/50 mcg inhalation powderInhalationFluticasone propionate and SalmeterolMylan PharmaceuticalsUS FDAAvailable on request
Advair HFA 230 mcg/21 mcg inhalerInhalationFluticasone propionate and SalmeterolGlaxoSmithKlineUS FDAAvailable on request
Advair HFA 45 mcg/21 mcg inhalerInhalationFluticasone propionate and SalmeterolGlaxoSmithKlineUS FDAAvailable on request
AirDuo RespiClick 113 mcg/14 mcg inhalation powderInhalationFluticasone propionate and SalmeterolTeva RespiratoryUS FDAAvailable on request
AirDuo RespiClick 232 mcg/14 mcg inhalation powderInhalationFluticasone propionate and SalmeterolTeva RespiratoryUS FDAAvailable on request
AirDuo RespiClick 55 mcg/14 mcg inhalation powderInhalationFluticasone propionate and SalmeterolTeva RespiratoryUS FDAAvailable on request
Fluticasone Propionate and Salmeterol HFA 115 mcg/21 mcg inhalerInhalationFluticasone propionate and SalmeterolPrasco LaboratoriesUS FDAAvailable on request
Fluticasone Propionate and Salmeterol HFA 230 mcg/21 mcg inhalerInhalationFluticasone propionate and SalmeterolPrasco LaboratoriesUS FDAAvailable on request
Fluticasone Propionate and Salmeterol HFA 45 mcg/21 mcg inhalerInhalationFluticasone propionate and SalmeterolPrasco LaboratoriesUS FDAAvailable on request
Wixela Inhub 100 mcg/50 mcg inhalation powderInhalationFluticasone propionate and SalmeterolMylan PharmaceuticalsUS FDAAvailable on request
Wixela Inhub 500 mcg/50 mcg inhalation powderInhalationFluticasone propionate and SalmeterolMylan PharmaceuticalsUS FDAAvailable on request

Brands by market

6 brand names across 1 markets.

Brand names by country

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 24 August 2000Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Fluticasone propionate and Salmeterol available for export from India?

Yes, on request. MedsAcross lists 24 presentations of Fluticasone propionate and Salmeterol and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Fluticasone propionate and Salmeterol have?

The catalogue lists 6 brand names for Fluticasone propionate and Salmeterol, including Advair Diskus, Advair HFA, AirDuo RespiClick, Fluticasone Propionate and Salmeterol DISKUS, Fluticasone Propionate and Salmeterol HFA, Wixela Inhub.

Is Fluticasone propionate and Salmeterol approved by the US FDA?

Yes. The US FDA first approved Fluticasone propionate and Salmeterol on 24 August 2000, according to Drugs@FDA.

Is Fluticasone propionate and Salmeterol authorised in the European Union?

Yes. Fluticasone propionate and Salmeterol has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.

Does Fluticasone propionate and Salmeterol need cold chain shipping?

No listed presentation of Fluticasone propionate and Salmeterol is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

Which ATC class is Fluticasone propionate and Salmeterol in?

Fluticasone propionate and Salmeterol is classified under ATC code R03AK06 (Fluticasone propionate and Salmeterol).

References

  1. ADVAIR DISKUS prescribing information (GlaxoSmithKline). U.S. National Library of Medicine, DailyMed. Retrieved 26 March 2026
  2. Seffalair Spiromax: European public assessment report (EPAR). European Medicines Agency. Retrieved 1 September 2026

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