AZELASTINE HYDROCHLORIDE solution/ drops

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

AZELASTINE HYDROCHLORIDE (UNII: 0L591QR10I) (AZELASTINE - UNII:ZQI909440X)

Saatavilla:

Apotex Corp.

INN (Kansainvälinen yleisnimi):

AZELASTINE HYDROCHLORIDE

Koostumus:

AZELASTINE HYDROCHLORIDE 0.5 mg in 1 mL

Antoreitti:

INTRAOCULAR

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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.

Tuoteyhteenveto:

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

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

AZELASTINE HYDROCHLORIDE- AZELASTINE HYDROCHLORIDE SOLUTION/ DROPS
APOTEX CORP.
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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