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Lotemax Gel

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Lotemax Gel

CLINICAL PHARMACOLOGY

Mechanism of Action

Corticosteroids inhibit the inflammatory response to a variety of inciting agents and probably delay or slow healing. They inhibit the edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation. While glucocorticoids are known to bind to and activate the glucocorticoid receptor, the molecular mechanisms involved in glucocorticoid/glucocorticoid receptor-dependent modulation of inflammation are not clearly established. However, corticosteroids are thought to inhibit prostaglandin production through several independent mechanisms.

Pharmacokinetics

Loteprednol is lipid soluble and can penetrate into cells. Loteprednol etabonate is synthesized through structural modifications of prednisolonerelated compounds so that it will undergo a predictable transformation to an inactive metabolite. Based upon in vivo and in vitro preclinical metabolism studies, loteprednol etabonate undergoes extensive metabolism to the inactive carboxylic acid metabolites, PJ-91 and PJ-90. The systemic exposure to loteprednol etabonate following ocular administration of LOTEMAX has not been studied in humans.

Clinical Studies

In two randomized, multicenter, double-masked, parallel-group, vehicle-controlled studies in 813 subjects with, post-operative inflammation, LOTEMAX was more effective compared to its vehicle in resolving anterior chamber inflammation and pain following cataract surgery. Primary endpoints were complete resolution of anterior chamber cells (cell count of 0) and no pain at post-operative day 8.

In these studies, LOTEMAX had a statistically significant higher incidence of subjects with complete clearing of anterior chamber cells (31% vs. 14-16%) and were pain free at post-operative day 8 (73-76% vs. 42-46%).

Last reviewed on RxList: 10/26/2012
This monograph has been modified to include the generic and brand name in many instances.

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