Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Azelastine hydrochloride ophthalmic solution, 0.05% is supplied as follows: 6 mL (NDC 72266-141-01) solution in a 10 mL LDPE container with a LDPE dropper tip and a white HDPE screw cap. Storage Store UPRIGHT between 2° and 25°C (36° and 77°F). Rx Only Distributed by: Fosun Pharma USA Inc. Princeton, NJ 08540 Made in India. November 2019 1313000421-01; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Container Label: 6 mL Azelastine Hydrochloride Ophthalmic Solution 0.05% For use in the eyes only Rx only Carton Label: 6 mL Azelastine Hydrochloride Ophthalmic Solution 0.05% For use in the eyes only Rx only container carton
- HOW SUPPLIED Azelastine hydrochloride ophthalmic solution, 0.05% is supplied as follows: 6 mL (NDC 72266-141-01) solution in a 10 mL LDPE container with a LDPE dropper tip and a white HDPE screw cap. Storage Store UPRIGHT between 2° and 25°C (36° and 77°F). Rx Only Distributed by: Fosun Pharma USA Inc. Princeton, NJ 08540 Made in India. November 2019 1313000421-01
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Container Label: 6 mL Azelastine Hydrochloride Ophthalmic Solution 0.05% For use in the eyes only Rx only Carton Label: 6 mL Azelastine Hydrochloride Ophthalmic Solution 0.05% For use in the eyes only Rx only container 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 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. chemical-structure.jpg
Indications & Usage
Azelastine hydrochloride ophthalmic solution 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 is for ocular use only and not for injection or oral use.
Contraindications
Azelastine hydrochloride ophthalmic solution 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. To report SUSPECTED ADVERSE REACTIONS, contact Fosun Pharma USA Inc. at 1-866-611-3762 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Similar Drugs
Related medications based on brand, generic name, substance, active ingredients.