AZELASTINE HYDROCHLORIDE solution/ drops

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

RPK Pharmaceuticals, Inc.

Οδός χορήγησης:

INTRAOCULAR

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Azelastine Hydrochloride Ophthalmic Solution, 0.05% is indicated for the treatment of itching of the eye associated with allergic conjunctivitis. Azelastine Hydrochloride Ophthalmic Solution, 0.05% is contraindicated in persons with known or suspected hypersensitivity to any of its components.

Περίληψη προϊόντος:

Product: 53002-1803 NDC: 53002-1803-1 6 mL in a BOTTLE, PLASTIC / 1 in a CARTON

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

AZELASTINE HYDROCHLORIDE- AZELASTINE HYDROCHLORIDE SOLUTION/ DROPS
RPK PHARMACEUTICALS, INC.
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AZELASTINE HYDROCHLORIDE OPHTHALMIC SOLUTION, 0.05%
DESCRIPTION
Azelastine Hydrochloride Ophthalmic Solution, 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:
Empirical chemical structure: C
H
ClN 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.
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.
1
22
24
3
1
PHARMACOKINETICS AND METABOLISM:
Absorption of azelastine following ocular administration was
relatively low. A study in
symptomatic patients receiving one drop of Azelasti