Azelastine Hydrochloride / Fluticasone Propionate

What it is and how it works

Mechanism of Action 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.

Indications

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.

Dosage and administration (summary)

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. Recommended Dosage The recommended dosage of azelastine hydrochloride and fluticasone propionate nasal spray is 1 spray (137 mcg of azelastine hydrochloride and 50 mcg of fluticasone propionate) in each nostril twice daily. Important Administration Instructions Administer azelastine hydrochloride and fluticasone propionate nasal spray by the nasal route only. Shake the bottle gently before each use. Avoid spraying azelastine hydrochloride and fluticasone propionate nasal spray into the eyes.

Contraindications

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. Reactions have included anaphylaxis.

Warnings and precautions

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.

Pregnancy

Pregnancy Risk Summary Limited data from postmarketing experience with azelastine hydrochloride and fluticasone propionate nasal spray in pregnant women have not identified any drug associated risks of miscarriage, birth defects, or other adverse maternal or fetal outcomes.

Storage and supply

How Supplied: Azelastine hydrochloride and fluticasone propionate nasal spray (NDC 0480- 2157 -57) is a milky white suspension supplied in an amber glass bottle fitted with a metered-dose spray pump unit. The spray pump unit consists of a nasal spray pump with a white nasal adapter and clear plastic dust cap.

Source: Azelastine Hydrochloride And Fluticasone Propionate (Azelastine Hydrochloride And Fluticasone Propionate) — US FDA prescribing information, 2025-01-01, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.