Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Azelastine hydrochloride ophthalmic solution, 0.05% is supplied as follows: 6 mL (NDC# 47335-938-90) solution in a translucent 10 mL HDPE container with a LDPE dropper tip, and a white HDPE screw cap. Storage STORE UPRIGHT at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - LABEL NDC 47335-938-90 Azelastine Hydrochloride Ophthalmic Solution, 0.05% 6 mL - Sterile For the Eye Only Rx only azelastine-label; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - CARTON NDC 47335-938-90 Azelastine Hydrochloride Ophthalmic Solution, 0.05% 6 mL - Sterile For the Eye Only Rx only SUN PHARMA spl-azelastine-carton
- HOW SUPPLIED Azelastine hydrochloride ophthalmic solution, 0.05% is supplied as follows: 6 mL (NDC# 47335-938-90) solution in a translucent 10 mL HDPE container with a LDPE dropper tip, and a white HDPE screw cap. Storage STORE UPRIGHT at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - LABEL NDC 47335-938-90 Azelastine Hydrochloride Ophthalmic Solution, 0.05% 6 mL - Sterile For the Eye Only Rx only azelastine-label
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - CARTON NDC 47335-938-90 Azelastine Hydrochloride Ophthalmic Solution, 0.05% 6 mL - Sterile For the Eye Only Rx only SUN PHARMA spl-azelastine-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 CIN 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: 0.25 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. chemical structure
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 to 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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