国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
AZELASTINE HYDROCHLORIDE (UNII: 0L591QR10I) (AZELASTINE - UNII:ZQI909440X)
Apotex Corp.
AZELASTINE HYDROCHLORIDE
AZELASTINE HYDROCHLORIDE 0.5 mg in 1 mL
INTRAOCULAR
PRESCRIPTION DRUG
Azelastine hydrochloride ophthalmic solution is indicated for the treatment of itching of the eye associated with allergic conjunctivitis. Azelastine hydrochloride ophthalmic solution is contraindicated in persons with known or suspected hypersensitivity to any of its components.
Azelastine Hydrochloride Ophthalmic Solution USP, 0.05% is supplied as follows: 6 mL (NDC# 60505-0578-4) solution in a translucent 11 mL HDPE container with a LDPE dropper tip, and a white HDPE screw cap. Storage Store UPRIGHT at 20ºC to 25ºC (68ºF to 77ºF) [See USP Controlled Room Temperature]. Azelastine Hydrochloride Ophthalmic Solution, USP 0.05% Manufactured by: Manufactured for: Apotex Inc. Apotex Corp. Toronto, Ontario Weston, FL Canada M9L 1T9 33326 July 2019
Abbreviated New Drug Application
AZELASTINE HYDROCHLORIDE- AZELASTINE HYDROCHLORIDE SOLUTION/ DROPS APOTEX CORP. ---------- AZELASTINE HYDROCHLORIDE OPHTHALMIC SOLUTION, USP 0.05% DESCRIPTION Azelastine Hydrochloride Ophthalmic Solution USP, 0.05% is a sterile ophthalmic solution containing azelastine hydrochloride, a relatively selective H -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: 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, hydroxypropylmethylcellulose, sodium hydroxide, sorbitol solution and water for injection. It has a pH of approximately 5.0 to 6.5 and an osmolality of approximately 265 to 375 mOsmol/kg. CLINICAL PHARMACOLOGY Azelastine hydrochloride is a relatively selective histamine H antagonist and an inhibitor of the release of histamine and other mediators from cells (e.g. mast cells) involved in the allergic response. Based on in vitro studies using human cell lines, inhibition of other mediators involved in allergic reactions (e.g. leukotrienes and PAF) has been demonstrated with azelastine hydrochloride. Decreased chemotaxis and activation of eosinophils has also been demonstrated. PHARMACOKINETICS AND METABOLISM Absorption of azelastine following ocular administration was relatively low. A study in symptomatic patients receiving one drop of azelastine hydrochloride ophthalmic solution in each eye two to 完全なドキュメントを読む