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U.S. Department of Health and Human Services


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Zylet (loteprednol etabonate and tobramycin) ophthalmic suspension

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – June 2010

Summary View


Pediatric Use
  • In a trial to evaluate the safety and efficacy of Zylet in pediatric patients age zero to six years with lid inflammation, Zylet with warm compresses did not demonstrate efficacy compared to vehicle with warm compresses. Patients received warm compress lid treatment plus Zylet or vehicle for 14 days. The majority of patients in both treatment groups showed reduced lid inflammation. There were no differences in safety assessments between treatment groups.