Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Azelastine Hydrochloride Ophthalmic Solution, 0.05% is supplied sterile in a natural LDPE plastic bottle with a natural LDPE dropper tip and a white polypropylene cap as follows: 6 mL in 8 mL bottle NDC 61314-308-02 Storage Azelastine Hydrochloride Ophthalmic Solution, 0.05% 6 mL container: STORE UPRIGHT between 2° and 25°C (36° and 77°F). Rx Only Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc. Princeton, NJ 08540 Printed in USA Rev. August 2021 300049853-0821; PRINCIPAL DISPLAY PANEL NDC 61314-308-02 Azelastine Hydrochloride Ophthalmic Solution 0.05% FOR TOPICAL APPLICATION IN THE EYE Rx only Sterile 6 mL SANDOZ carton
- HOW SUPPLIED Azelastine Hydrochloride Ophthalmic Solution, 0.05% is supplied sterile in a natural LDPE plastic bottle with a natural LDPE dropper tip and a white polypropylene cap as follows: 6 mL in 8 mL bottle NDC 61314-308-02 Storage Azelastine Hydrochloride Ophthalmic Solution, 0.05% 6 mL container: STORE UPRIGHT between 2° and 25°C (36° and 77°F). Rx Only Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc. Princeton, NJ 08540 Printed in USA Rev. August 2021 300049853-0821
- PRINCIPAL DISPLAY PANEL NDC 61314-308-02 Azelastine Hydrochloride Ophthalmic Solution 0.05% FOR TOPICAL APPLICATION IN THE EYE Rx only Sterile 6 mL SANDOZ carton
Overview
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 22 H 24 ClN 3 O•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 : 0.125 mg benzalkonium chloride; Inactives : disodium edetate dihydrate, hypromellose, sorbitol solution, sodium hydroxide and water for injection. It has a pH of approximately 5.0 to 6.5 and an osmolarity of approximately 271 to 312 mOsmol/L. Structure
Indications & Usage
Azelastine Hydrochloride Ophthalmic Solution, 0.05% is indicated for the treatment of itching of the eye associated with allergic conjunctivitis.
Dosage & Administration
The recommended dose is one drop instilled into each affected eye twice a day.
Warnings & Precautions
WARNINGS Azelastine Hydrochloride Ophthalmic Solution, 0.05% is for ocular use only and not for injection or oral use.
Contraindications
Azelastine Hydrochloride Ophthalmic Solution, 0.05% is contraindicated in persons with known or suspected hypersensitivity to any of its components.
Adverse Reactions
In controlled multiple-dose studies where patients were treated for up to 56 days, the most frequently reported adverse reactions were transient eye burning/stinging (approximately 30%), headaches (approximately 15%) and bitter taste (approximately 10%). The occurrence of these events was generally mild. The following events were reported in 1–10% of patients: asthma, conjunctivitis, dyspnea, eye pain, fatigue, influenza-like symptoms, pharyngitis, pruritus, rhinitis and temporary blurring. Some of these events were similar to the underlying disease being studied.
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