Azelastine Hydrochloride Solution/ Drops
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Questions & Answers
Side Effects & Adverse Reactions
Azelastine hydrochloride ophthalmic solution is for ocular use only and not for injection or oral use.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Azelastine hydrochloride ophthalmic solution is indicated for the treatment of itching of the eye associated with allergic conjunctivitis.
History
There is currently no drug history available for this drug.
Other Information
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.
Sources
Azelastine Hydrochloride Solution/ Drops Manufacturers
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Sun Pharma Global Fze
![Azelastine Hydrochloride Solution/ Drops [Sun Pharma Global Fze]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Azelastine Hydrochloride Solution/ Drops | Sun Pharma Global Fze
The recommended dose is one drop instilled into each affected eye twice a day. -
Apotex Corp.
Azelastine Hydrochloride Solution/ Drops | Apotex Corp.
The recommended dose is one drop instilled into each affected eye twice a day.
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Sandoz Inc
Azelastine Hydrochloride Solution/ Drops | Sandoz Inc
The recommended dose is one drop instilled into each affected eye twice a day.
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Wallace Pharmaceuticals Inc.
Azelastine Hydrochloride Solution/ Drops | Wallace Pharmaceuticals Inc.
The recommended dose is one drop instilled into each affected eye twice a day.
![Azelastine Hydrochloride Solution/ Drops [Apotex Corp.]](http://recallguide.cwdevelopsp.com/wp-content/themes/recallguide/assets/img/drug-image-placeholder.jpg)
![Azelastine Hydrochloride Solution/ Drops [Sandoz Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=6945fb86-27fb-4bab-8908-98772c6269c5&name=6945fb86-27fb-4bab-8908-98772c6269c5-02.jpg)
![Azelastine Hydrochloride Solution/ Drops [Wallace Pharmaceuticals Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=f2f72f86-c1c8-11df-851a-0800200c9a66&name=azelastine-hydrochloride-figure-2.jpg)
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