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Azelastine

Generic Name
Azelastine
Brand Names
Astelin, Astepro, Astepro Allergy, Dymista
Drug Type
Small Molecule
Chemical Formula
C22H24ClN3O
CAS Number
58581-89-8
Unique Ingredient Identifier
ZQI909440X

Overview

Azelastine, a phthalazine derivative, is an antihistamine available as an intranasal spray for the treatment of allergic and vasomotor rhinitis and as an ophthalmic solution for the treatment of allergic conjunctivitis. It is a racemic mixture, though there is no noted difference in pharmacologic activity between enantiomers, and was first granted FDA approval in 1996. Azelastine is also available in combination with fluticasone propionate as a nasal spray marketed under the trade name Dymista™, which is indicated for the symptomatic treatment of seasonal allergic rhinitis in patients 6 years of age and older.

Background

Azelastine, a phthalazine derivative, is an antihistamine available as an intranasal spray for the treatment of allergic and vasomotor rhinitis and as an ophthalmic solution for the treatment of allergic conjunctivitis. It is a racemic mixture, though there is no noted difference in pharmacologic activity between enantiomers, and was first granted FDA approval in 1996. Azelastine is also available in combination with fluticasone propionate as a nasal spray marketed under the trade name Dymista™, which is indicated for the symptomatic treatment of seasonal allergic rhinitis in patients 6 years of age and older.

Indication

Intranasal azelastine is indicated for the symptomatic treatment of seasonal allergic rhinitis in patients 5 years and older and for the symptomatic treatment of vasomotor rhinitis in patients 12 years and older. Ophthalmic azelastine solution is indicated for the treatment of itchy eyes associated with allergic conjunctivitis. As a 0.15% nasal spray, azelastine hydrochloride is also indicated for over-the-counter treatment of allergies in patients aged six years and older.

Associated Conditions

  • Allergic Conjunctivitis (AC)
  • Allergic Rhinitis (AR)
  • Allergy to Tree Pollen
  • Atopy Keratoconjunctivitis
  • Blepharitis allergic
  • Perennial Allergic Rhinitis (PAR)
  • Seasonal Allergic Rhinitis
  • Vasomotor Rhinitis
  • Allergic eye disorders

FDA Approved Products

Azelastine Hydrochloride
Manufacturer:Akorn
Route:NASAL
Strength:1.5 mg in 1 mL
Approved: 2022/03/01
NDC:50383-942
Azelastine Hydrochloride
Manufacturer:A-S Medication Solutions
Route:NASAL
Strength:1 mg in 1 mL
Approved: 2020/12/28
NDC:50090-3833
Azelastine Hydrochloride
Manufacturer:Gland Pharma Limited
Route:INTRAOCULAR
Strength:0.5 mg in 1 mL
Approved: 2022/10/10
NDC:68083-287
Azelastine Hydrochloride
Manufacturer:NuCare Pharmaceuticals,Inc.
Route:NASAL
Strength:137 ug in 1 1
Approved: 2021/08/09
NDC:68071-2497
Azelastine Hydrochloride Ophthalmic Solution 0.05%
Manufacturer:Alembic Pharmaceuticals Inc.
Route:OPHTHALMIC
Strength:0.5 mg in 1 mL
Approved: 2022/05/13
NDC:62332-506

Singapore Approved Products

SYNAZE NASAL SPRAY
Manufacturer:Cipla Limited
Form:SPRAY, METERED
Strength:0.1 %w/w
Online:Yes
Approved: 2017/06/05
Approval:SIN15256P
DYMISTA NASAL SPRAY
Manufacturer:Cipla Limited
Form:SPRAY, METERED
Strength:0.1 %w/w
Online:Yes
Approved: 2017/06/05
Approval:SIN15255P

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