Dymista (azelastine hydrochloride and fluticasone
propionate) nasal spray is formulated as a white, uniform metered-spray
suspension for intranasal administration. It is a fixed dose combination
product containing an antihistamine (H1 receptor antagonist) and a
corticosteroid as active ingredients.
Azelastine hydrochloride active ingredient occurs as a
white, odorless, crystalline powder with a bitter taste. It has a molecular
weight of 418.37. It is sparingly soluble in water, methanol, and propylene
glycol and slightly soluble in ethanol, octanol, and glycerin. It has a melting
point of 225°C and the pH of 5.2. Its chemical name is
methyl]-2-(hexahydro-1-methyl-1H-azepin-4-yl)-, monohydrochloride. Its molecular
formula is C22H24ClN3O•HCl with the following
Fluticasone propionate active
ingredient is a white powder with a melting point of 273°C, a molecular weight
of 500.6, and the empirical formula is C25H31F3O5S.
It is practically insoluble in water, freely soluble in dimethyl sulfoxide and
dimethylformamide, and slightly soluble in methanol and 95% ethanol.
Fluticasone propionate is a synthetic corticosteroid having the chemical name
17-propionate, and the following chemical structure:
Dymista (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 glycerin,
microcrystalline cellulose and carboxymethylcellulose sodium, phenylethyl
alcohol (2.5 mg/g), edetate disodium, benzalkonium chloride (0.1 mg/g),
polysorbate 80, and purified water. It has a pH of approximately 6.0.
After priming [see DOSAGE AND
ADMINISTRATION], 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.
Last reviewed on RxList: 9/13/2012
This monograph has been modified to include the generic and brand name in many instances.