|
INDICATIONS
|
Azelastine Hydrochloride Ophthalmic Solution, 0.05% is indicated for the treatment of itching of the eye associated with allergic conjunctivitis.
|
|
MECHANISM OF ACTION
|
Combo Mast Cell Stabilizer / Anti H1
|
|
MICROBIOLOGY
|
Azelastine hydrochloride is a relatively selective histamine H1 antagonist and an inhibitor 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.
|
|
CONTRAINDICATIONS & WARNINGS
|
Azelastine Hydrochloride Ophthalmic Solution, 0.05% is contraindicated in persons with known or suspected hypersensitivity to any of its components.
|
|
PEDIATRIC USE
|
Safety and effectiveness in pediatric patients below the age of 3 have not been established.
|
|
PREGNANCY
|
Category C: Teratogenic Effects: Pregnancy Category C. Azelastine hydrochloride has been shown to be embryotoxic, fetotoxic, and teratogenic (external and skeletal abnormalities) in mice There are no adequate and well-controlled studies in pregnant women. Azelastine Hydrochloride Ophthalmic Solution, 0.05% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
|
|
NOTE
|
Contains BAK 0.0125% which may be absorbed into soft lenses. Wait at least ten minutes after instilling Optivar before inserting contact lenses.
|
