Epinastine Hydrochloride Solution/ Drops Recall
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Questions & Answers
Side Effects & Adverse Reactions
Epinastine HCl ophthalmic solution, 0.05% is for topical ophthalmic use only and not for injection or oral use.
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FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Epinastine HCl ophthalmic solution, 0.05% is indicated for the prevention of itching associated with allergic conjunctivitis.
There is currently no drug history available for this drug.
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:
C16H15N3 ∙ HCl Mol. Wt. 285.78
3-Amino-9, 13b-dihydro-1H-dibenz[c,f]imidazo[1,5-a]azepine hydrochloride
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, dihydrate; purified water; sodium chloride; sodium phosphate monobasic, anhydrous; and sodium hydroxide and/or hydrochloric acid (to adjust the pH). Epinastine HCl ophthalmic solution, 0.05% has a pH of approximately 7 and an osmolality range of 250 to 310 mOsm/kg.