AZELASTINE HYDROCHLORIDE solution/ drops

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Sandoz Inc

Njia ya uendeshaji:

INTRAOCULAR

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

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.

Bidhaa muhtasari:

Azelastine Hydrochloride Ophthalmic Solution, 0.05% is supplied sterile in a natural LDPE plastic bottle with a natural LDPE dropper tip and a white polypropylene cap as follows: Storage Azelastine Hydrochloride Ophthalmic Solution, 0.05% 6 mL container: STORE UPRIGHT between 2° and 25°C (36° and 77°F). Rx Only Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc. Princeton, NJ 08540 Printed in USA Rev. August 2021 300049853-0821

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

AZELASTINE HYDROCHLORIDE- AZELASTINE HYDROCHLORIDE SOLUTION/ DROPS
SANDOZ INC
----------
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 Azelastine Hydrochlorid