Azelastine hydrochloride ophthalmic solution is for ocular use only and not for injection or oral use.
There is currently no manufacturer warning information available for this drug.
Azelastine hydrochloride ophthalmic solution is indicated for the treatment of itching of the eye associated with allergic conjunctivitis.
Azelastine hydrochloride ophthalmic solution, 0.05% is a sterile ophthalmic solution containing azelastine hydrochloride, a relatively selective H
1-receptor antagonist for topical administration to the eyes. Azelastine hydrochloride is a white crystalline powder with a molecular weight of 418.37. Azelastine hydrochloride is sparingly soluble in water, methanol and propylene glycol, and slightly soluble in ethanol, octanol and glycerine. Azelastine hydrochloride is a racemic mixture with a melting point of 225°C. The chemical name for azelastine hydrochloride is (±)-1-(2H)-phthalazinone,4-[(4-chlorophenyl) methyl]-2-(hexahydro-1-methyl-1H-azepin-4-yl)-, monohydrochloride and is represented by the following chemical structure:
Empirical chemical structure: C
22H
24CIN
3O•HCl
Each mL of azelastine hydrochloride ophthalmic solution, 0.05% contains:
Active: 0.5 mg azelastine hydrochloride, equivalent to 0.457 mg of azelastine base;
Preservative: 0.25 mg benzalkonium chloride solution (50%) USP-NF;
Inactives: disodium edetate dihydrate, hypromellose, sorbitol solution, sodium hydroxide and water for injection. It has a pH of approximately 5 to 6.5 and an osmolality of approximately 271 to 312 mOsmol/L.
