AZELASTINE HCL OPHTHALMIC SOLUTION 0.05% 6 ML
Generic: Azelastine Hydrochloride
AZELASTINE HCL OPHTHALMIC SOLUTION 0.05% 6 ML
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Identification
Azelastine Hydrochloride
Azelastine Hydrochloride
Sun Pharmaceutical Industries, Inc.
HUMAN PRESCRIPTION DRUG
Administration
SOLUTION/ DROPS
INTRAOCULAR
ANDA078738
Active Ingredients
| Ingredient | Strength |
|---|---|
| AZELASTINE HYDROCHLORIDE | .5 mg/mL |
Pharmacological Class
Data sourced from openFDA / DailyMed. For full prescribing information, consult the drug label.
Wholesale compliance resources
Clinical Drug Information
Indications & Usage
INDICATIONS AND USAGE Azelastine hydrochloride ophthalmic solution is indicated for the treatment of itching of the eye associated with allergic conjunctivitis.
Warnings
WARNINGS Azelastine hydrochloride ophthalmic solution is for ocular use only and not for injection or oral use.
Dosage & Administration
DOSAGE AND ADMINISTRATION The recommended dose is one drop instilled into each affected eye twice a day.
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 to 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.
Information for Patients
Information for Patients To prevent contaminating the dropper tip and solution, care should be taken not to touch any surface, the eyelids or surrounding areas with the dropper tip of the bottle. Keep bottle tightly closed when not in use. This product is sterile when packaged. Patients should be advised not to wear a contact lens if their eye is red. Azelastine hydrochloride ophthalmic solution should not be used to treat contact lens related irritation. The preservative in azelastine hydrochloride ophthalmic solution, benzalkonium chloride, may be absorbed by soft contact lenses. Patients who wear soft contact lenses and whose eyes are not red , should be instructed to wait at least ten minutes after instilling azelastine hydrochloride ophthalmic solution before they insert their contact lenses.
Clinical data sourced from openFDA drug labeling. For complete prescribing information, consult the full drug label.