Fixed-dose combination
Azelastine and Fluticasone propionate is a fixed-dose combination of a corticosteroid and a histamine-1 receptor antagonist indicated for the relief of symptoms of seasonal allergic rhinitis in adult, among other approved uses. MedsAcross supplies Azelastine and Fluticasone propionate 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.
Azelastine hydrochloride and fluticasone propionate nasal spray is indicated for the relief of symptoms of seasonal allergic rhinitis in adult and pediatric patients 6 years of age and older. Azelastine hydrochloride and fluticasone propionate nasal spray contains an H 1 -receptor antagonist and a corticosteroid, and is indicated for the relief of symptoms of seasonal allergic rhinitis in adult and pediatric patients 6 years of age and older.
Source: US FDA prescribing information
Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray Azelastine hydrochloride and fluticasone propionate nasal spray contains both azelastine hydrochloride and fluticasone propionate, therefore, the mechanisms of actions described below for the individual components apply to azelastine hydrochloride and fluticasone propionate nasal spray. These drugs represent two different classes of medications (histamine H 1 -receptor antagonist and synthetic corticosteroid). Azelastine Hydrochloride Azelastine hydrochloride, a phthalazinone derivative, exhibits histamine H 1 -receptor antagonist activity in isolated tissues, animal models, and humans. Azelastine hydrochloride in azelastine hydrochloride and fluticasone propionate nasal spray is administered as a racemic mixture with no difference in pharmacologic activity noted between the enantiomers in in vitro studies.
Source: US FDA prescribing information
• Recommended dosage: 1 spray per nostril twice daily. • For nasal use only. • Prime before initial use and when it has not been used for 14 or more days.
Source: US FDA prescribing information
Azelastine hydrochloride and fluticasone propionate nasal spray is contraindicated in patients with hypersensitivity to azelastine hydrochloride, fluticasone propionate, or to any other ingredients of azelastine hydrochloride and fluticasone propionate nasal spray. Reactions have included anaphylaxis. Hypersensitivity to azelastine hydrochloride, fluticasone propionate, or to any ingredients of azelastine hydrochloride and fluticasone propionate nasal spray.
Source: US FDA prescribing information
• Somnolence: Avoid engaging in hazardous occupations requiring complete mental alertness such as driving or operating machinery when taking azelastine hydrochloride and fluticasone propionate nasal spray. • Avoid concurrent use of alcohol or other central nervous system (CNS) depressants with azelastine hydrochloride and fluticasone propionate nasal spray because further decreased alertness and impairment of CNS performance may occur. • Epistaxis, nasal ulcerations, nasal septal perforation, impaired wound healing, Candida albicans infection: Monitor patients periodically for signs of adverse effects on the nasal mucosa. Avoid use in patients with recent nasal ulcers, nasal surgery, or nasal trauma. • Glaucoma or posterior subcapsular cataracts: Monitor patients closely with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts.
Source: US FDA prescribing information
The following clinically significant adverse reactions are described elsewhere in the labeling: • Somnolence • Local nasal effects, including epistaxis, nasal ulceration, nasal septal perforation, impaired wound healing, and Candida albicans infection • Glaucoma and Cataracts • Immunosuppression and Risk of Infections • Hypercorticism and Adrenal Suppression, including growth reduction The most common adverse reactions (≥ 2% incidence) are: dysgeusia, epistaxis, and headache.
Source: US FDA prescribing information
No formal drug interaction studies have been performed with azelastine hydrochloride and fluticasone propionate nasal spray. The drug interactions of the combination are expected to reflect those of the individual components. • Potent inhibitors of cytochrome P450 (CYP) 3A4: May increase blood levels of fluticasone propionate. • Ritonavir: Coadministration is not recommended. • Other potent CYP3A4 inhibitors, such as ketoconazole: use caution with coadministration.
Source: US FDA prescribing information
Store upright with the dust cap in place at controlled room temperature 20°C to 25°C (68°F to 77°F). Do not store in the freezer or refrigerator. Protect from light.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
2 presentations of Azelastine and Fluticasone propionate, sorted by availability.
| Medicine | Active ingredient | Manufacturer | Register | Availability |
|---|---|---|---|---|
| Azelastine and Fluticasone propionate 137 mcg/50 mcg nasal sprayNasalGeneric name | Azelastine and Fluticasone propionate | — | US FDA | Available on request |
| Dymista 137 mcg/50 mcg nasal sprayNasal | Azelastine and Fluticasone propionate | Viatris Specialty | 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.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 1 May 2012 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Yes, on request. MedsAcross lists 2 presentations of Azelastine and Fluticasone propionate and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Azelastine and Fluticasone propionate, including Dymista.
Yes. The US FDA first approved Azelastine and Fluticasone propionate on 1 May 2012, according to Drugs@FDA.
No listed presentation of Azelastine and Fluticasone propionate is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.