loteprednol etabonate

FDA Drug Profile — Loteprednol Etabonate, LOTEPREDNOL ETABONATE, Alrex, loteprednol etabonate, LOTEMAX

Drug Details

Generic Name
loteprednol etabonate
Brand Names
Loteprednol Etabonate, LOTEPREDNOL ETABONATE, Alrex, loteprednol etabonate, LOTEMAX, Lotemax, Inveltys, Lotemax SM, Eysuvis
Application Number
NDA020583
Sponsor
Bausch & Lomb Americas Inc.
NDC Codes
23
Dosage Forms
SUSPENSION/ DROPS, GEL, POWDER, OINTMENT, SUSPENSION
Routes
OPHTHALMIC, TOPICAL
Active Ingredients
LOTEPREDNOL ETABONATE

Indications and Usage

INDICATIONS AND USAGE Loteprednol etabonate ophthalmic suspension is indicated for the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis.

Warnings

WARNINGS Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation. Steroids should be used with caution in the presence of glaucoma. Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. In acute purulent conditions of the eye, steroids may mask infection or enhance existing infection. Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution.