Jane S. Ricciuti, RPh, MS


February 07, 2005

In This Article

Ophthalmic Agents

Manufacturer: Bausch & Lomb, Inc.

Drug Approval Classification: Original New Drug Application (Approval Date: 12/14/04)

Indication: Zylet (loteprednol etabonate and tobramycin) 0.5%/0.3% ophthalmic suspension is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.

Dosing: The Zylet suspension must be shaken prior to use. The recommended dose is 1 or 2 drops into the conjunctival sac of the affected eye(s) every 4 to 6 hours. During the initial 24 to 48 hours, the dosing may be increased, to every 1 to 2 hours. Frequency should be decreased gradually as warranted by improvement in clinical signs.

Clinical Summary: Zylet is a sterile, multiple-dose, topical anti-inflammatory corticosteroid and antibiotic combination for ophthalmic use. Loteprednol etabonate is structurally similar to other corticosteroids.

Adverse Effects: In a 42-day safety study comparing Zylet to placebo, the incidence of ocular adverse events reported in greater than 10% of subjects included injection (approximately 20%) and superficial punctate keratitis (approximately 15%). Increased intraocular pressure was reported in 10% ( Zylet ) and 4% (placebo) of subjects. Nine percent (9%) of Zylet subjects reported burning and stinging upon instillation. Ocular reactions reported with an incidence less than 4% include vision disorders, discharge, itching, lacrimation disorder, photophobia, corneal deposits, ocular discomfort, eyelid disorder, and other unspecified eye disorders.


Zylet (loteprednol etabonate and tobramycin) 0.5%/0.3% Ophthalmic Suspension Labeling