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FDA Labeling Changes
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ELESTAT® ophthalmic solution is indicated for the prevention of itching associated with allergic conjunctivitis.
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ELESTAT® (epinastine HCl ophthalmic solution) 0.05% is a clear, colorless, sterile isotonic solution containing epinastine HCl, an antihistamine and an inhibitor of histamine release from the mast cell for topical administration to the eyes.
Epinastine HCl is represented by the following structural formula:
Each mL contains: Active: Epinastine HCl 0.05% (0.5 mg/mL) equivalent to epinastine 0.044% (0.44 mg/mL); Preservative: Benzalkonium chloride 0.01%; Inactives: Edetate disodium; purified water; sodium chloride; sodium phosphate, monobasic; and sodium hydroxide and/or hydrochloric acid (to adjust pH). ELESTAT® has a pH of approximately 7 and an osmolality range of 250 to 310 mOsm/kg.