Azelastinedrug info
azelastine hydrochloride 0.137 MG/ACTUAT / fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal Spray
What it is used for
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.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective January 1, 2025. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
Description
Azelastine hydrochloride and fluticasone propionate nasal spray is formulated as a white, uniform metered-spray suspension for nasal administration. It is a fixed dose combination product containing an antihistamine (H 1 receptor antagonist) and a corticosteroid as active ingredients. Azelastine hydrochloride, USP active ingredient occurs as a white or almost white, odorless, crystalline powder with a bitter taste. It has a molecular weight of 418.36. It is sparingly soluble in water, and is soluble in ethanol and in dichloromethane. It has a melting point of 225°C and the pH of 5.2. Its chemical name is 1-(2 H )-phthalazinone, 4-[(4-chlorophenyl)methyl]-2-(hexahydro-1-methyl-1 H -azepin-4-yl), monohydrochloride. Its molecular formula is C 22 H 24 ClN 3 O
HCl with the following chemical structure: Fluticasone propionate, USP active ingredient is a white or almost white powder with a melting point of 273°C, a molecular weight of 500.57, and the molecular formula is C 25 H 31 F 3 O 5 S. It is practically insoluble in water, sparingly soluble in methylene chloride, and slightly soluble in alcohol. Fluticasone propionate, USP is a synthetic corticosteroid having the chemical name Androsta-1,4-diene-17-carbothioic acid,6,9-difluoro-11-hydroxy-16-methyl-3-oxo-17-(1-oxopropoxy)-,(6α, 11β, 16α, 17α)- S -(fluoromethyl) ester, and the following chemical structure: Azelastine hydrochloride and fluticasone propionate nasal spray, 137 mcg/50 mcg contains 0.1% solution of azelastine hydrochloride and 0.037% suspension of micronized fluticasone propionate in an isotonic aqueous suspension containing benzalkonium chloride (0.1 mg/g), edetate disodium, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, phenylethyl alcohol (2.5 mg/g), polysorbate 80, and Water for Injection, USP q.s. It has a pH of approximately 6.0. After priming, each metered spray delivers a 0.137 mL mean volume of suspension containing 137 mcg of azelastine hydrochloride (equivalent to 125 mcg of azelastine base) and 50 mcg of fluticasone propionate. The 23 g bottle provides 120 metered sprays, after priming. 1 1
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective January 1, 2025. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
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