AZELASTINE HYDROCHLORIDE solution/ drops

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Wallace Pharmaceuticals Inc.

INN (Международно Name):

AZELASTINE HYDROCHLORIDE

Композиция:

AZELASTINE HYDROCHLORIDE 0.5 mg in 1 mL

Вид предписание :

PRESCRIPTION DRUG

Статус Оторизация:

New Drug Application Authorized Generic

Данни за продукта

AZELASTINE HYDROCHLORIDE- AZELASTINE HYDROCHLORIDE SOLUTION/ DROPS
WALLACE PHARMACEUTICALS INC.
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AZELASTINE HYDROCHLORIDE
OPHTHALMIC SOLUTION, 0.5%
DESCRIPTION
Azelastine Hydrochloride Ophthalmic Solution, 0.5% 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 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.
PHARMACOKINETICS AND METABOLISM
Absorption of azelastine following ocular administration was
relatively low. A study in symptomatic
patients receiving one drop of Azelastine Hydrochloride Op