Application Nr Approved Date Route Status External Links
NDA020583 None Ophthalmic None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Loteprednol Etabonate Ophthalmic Suspension Is Indicated For The Treatment Of Steroid Responsive Inflammatory Conditions Of The Palpebral And Bulbar Conjunctiva, Cornea And Anterior Segment Of The Globe Such As Allergic Conjunctivitis, Acne Rosacea, Superficial Punctate Keratitis, Herpes Zoster Keratitis, Iritis, Cyclitis, Selected Infective Conjunctivitides, When The Inherent Hazard Of Steroid Use Is Accepted To Obtain An Advisable Diminution In Edema And Inflammation. Loteprednol Etabonate Is Less Effective Than Prednisolone Acetate 1% In Two 28-Day Controlled Clinical Studies In Acute Anterior Uveitis, Where 72% Of Patients Treated With Loteprednol Etabonate Experienced Resolution Of Anterior Chamber Cells, Compared To 87% Of Patients Treated With Prednisolone Acetate 1%. The Incidence Of Patients With Clinically Significant Increases In Iop (≥10 Mmhg) Was 1% With Loteprednol Etabonate And 6% With Prednisolone Acetate 1%. Loteprednol Etabonate Should Not Be Used In Patients Who Require A More Potent Corticosteroid For This Indication. Loteprednol Etabonate Ophthalmic Suspension Is Also Indicated For The Treatment Of Post-Operative Inflammation Following Ocular Surgery.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Loteprednol Etabonate LOTEPREDNOL ETABONATE ZINC3920673

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