Rx Pharmaceuticals

Zylet® Pharmacology and Pharmacokinetics

Clinical bioavailability studies have demonstrated that the combination of loteprednol etabonate 0.5% and tobramycin 0.3% does not interfere with the bioavailabiltiy, and thus efficacy, of either component of the combination. In one such study of 1350 patients the levels of loteprednol etabonate in the aqueous humor were found to be comparable between loteprednol etabonate 0.5% and Zylet® (loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension) treatment groups.29

Loteprednol etabonate concentration in the aqueous humor (ng/mL) by treatment group.

A microbial kill rate study was performed to demonstrate antimicrobial equivalence between loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension, and tobramycin ophthalmic solution USP 0.3%. The antimicrobial activity of both products was demonstrated against 20 organisms-those indicated on the tobramycin ophthalmic solution, USP 0.3% . This in vitro study demonstrated that tobramycin has equivalent antimicrobial activity as a single agent and in combination with loteprednol etabonate.31

Additional information regarding Zylet pharmacology and pharmacokinetics can be found in the Zylet package insert. A Zylet product monograph and formulary dossier have also been prepared for healthcare professionals interested in learning more about this product.