AZELASTINE HYDROCHLORIDE solution/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Somerset Therapeutics, LLC

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Azelastine hydrochloride is indicated for the treatment of itching of the eye associated with allergic conjunctivitis. Azelastine hydrochloride is contraindicated in persons with known or suspected hypersensitivity to any of its components. 

Product summary:

Azelastine hydrochloride ophthalmic solution, 0.05% is supplied as follows: 6 mL (NDC # 70069-091-01) solution in 10 mL natural HDPE bottle plugged with natural LDPE nozzle and white HDPE screw cap. Storage Store UPRIGHT between 2° and 25°C (36° and 77°F). Rx only For Product Inquiry call [phone] Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024 Made in India Code No.:KR/DRUGS/KTK/28/289/97 Issued: December, 2019 ST-AZL11/P/02 PSSO0480

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AZELASTINE HYDROCHLORIDE - AZELASTINE HYDROCHLORIDE SOLUTION/ DROPS
SOMERSET THERAPEUTICS, LLC
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AZELASTINE HYDROCHLORIDE OPHTHALMIC SOLUTION, 0.05%
SOMERSET THERAPEUTICS, LLC
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)-, mono
hydrochloride 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
1
22
24
3
1
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