Epinastine Hydrochloride Solution/ Drops

Epinastine Hydrochloride Solution/ Drops

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.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

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.

Uses

Epinastine HCl ophthalmic solution, 0.05% is indicated for the prevention of itching associated with allergic conjunctivitis.

History

There is currently no drug history available for this drug.

Other Information

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:

Chemical Structure

C16H15N3 ∙ HCl        Mol. Wt. 285.78

Chemical Name

3-Amino-9, 13b-dihydro-1H-dibenz[c,f]imidazo[1,5-a]azepine hydrochloride

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, 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.

Epinastine Hydrochloride Solution/ Drops Manufacturers


  • Breckenridge Pharmaceutical, Inc.
    Epinastine Hydrochloride Solution/ Drops [Breckenridge Pharmaceutical, Inc.]
  • Perrigo Company
    Epinastine Hydrochloride Solution/ Drops [Perrigo Company]

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