INDICATIONS & USAGE Azelastine hydrochloride ophthalmic solution 0.05% is indicated for the treatment of itching of the eye associated with allergic conjunctivitis.

WARNINGS Azelastine hydrochloride ophthalmic solution 0.05% is for ocular use only and not for injection or oral use.

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.