April 29, 2017
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Azelastine Nasal Spray

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Azelastine Nasal Spray

AZELASTINE
(Azelastine HCl) Nasal Solution (Nasal Spray), 0 .15%

DRUG DESCRIPTION

Azelastine HCl Nasal Solution (Nasal Spray), 0.15%, 205.5 micrograms (mcg), is an antihistamine formulated as a metered-spray solution for intranasal administration.

Azelastine hydrochloride occurs as a white, almost 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 glycerine. It has a melting point of about 225°C and the pH of a saturated solution is between 5.0 and 5.4. Its chemical name is (±)-1-(2H)-phthalazinone, 4-[(4- chlorophenyl) methyl]-2-(hexahydro-1-methyl-1H-azepin-4-yl)-, monohydrochloride. Its molecular formula is C22H24ClN3O•HCl with the following chemical structure:

AZELASTINE HCL NASAL- azelas tine hcl Structural Formula Illustration

Azelastine HCl Nasal Solution (Nasal Spray), 0.15% contains 0.15% azelastine hydrochloride in an isotonic aqueous solution containing sorbitol, sucralose, hypromellose, sodium citrate, edetate disodium, benzalkonium chloride (125 mcg/mL), and purified water (pH 6.4).

After priming [see DOSAGE AND ADMINISTRATION], each metered spray delivers a 0.137 mL mean volume containing 205.5 mcg of azelastine hydrochloride (equivalent to 187.6 mcg of azelastine base). The 30-mL (net weight 30 gm of solution) bottle provides 200 metered sprays.

Last reviewed on RxList: 1/24/2017
This monograph has been modified to include the generic and brand name in many instances.

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