Azelastine Hydrochloride
Generic: AZELASTINE HYDROCHLORIDE
Basic Information
Manufacturer
Somerset Therapeutics, LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
OPHTHALMIC
FDA Set ID
72406ded-7886-41fb-b5c8-2d27a149aa34
Indications & Usage
INDICATIONS AND USAGE: Azelastine hydrochloride ophthalmic solution, 0.05% is indicated for the treatment of itching of the eye associated with allergic conjunctivitis.
Warnings
WARNINGS: Azelastine hydrochloride ophthalmic solution, 0.05% is for ocular use only and not for injection or oral use.
Adverse Reactions
ADVERSE REACTIONS: In controlled multiple-dose studies where patients were treated for up to 56 days, the most frequently reported adverse reactions were transient eye burning/stinging (approximately 30%), headaches (approximately 15%) and bitter taste (approximately 10%).
The occurrence of these events was generally mild.
The following events were reported in 1–10% of patients: asthma, conjunctivitis, dyspnea, eye pain, fatigue, influenza-like symptoms, pharyngitis, pruritus, rhinitis and temporary blurring.
Some of these events were similar to the underlying disease being studied.
The occurrence of these events was generally mild.
The following events were reported in 1–10% of patients: asthma, conjunctivitis, dyspnea, eye pain, fatigue, influenza-like symptoms, pharyngitis, pruritus, rhinitis and temporary blurring.
Some of these events were similar to the underlying disease being studied.