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Lotemax Ophthalmic Ointment

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Lotemax Ophthalmic Ointment

Lotemax Ophthalmic Ointment

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 glucocorticod 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

The systemic exposure to loteprednol etabonate following ocular administration of LOTEMAX ointment has not been studied in humans. However, results from a bioavailability study with LOTEMAX suspension in normal volunteers established that plasma concentrations of loteprednol etabonate and Δ1 cortienic acid etabonate (PJ 91), its primary, inactive metabolite, were below the limit of quantitation (1 ng/mL) at all sampling times. The results were obtained following the ocular administration of one drop in each eye of 0.5% loteprednol etabonate suspension, 8 times daily for 2 days or 4 times daily for 42 days. The maximum systemic exposure to loteprednol following administration of the ointment product dosed four times daily is not expected to exceed exposures attained with LOTEMAX suspension dosed up to two drops four times daily.

Clinical Studies

In two independent, randomized, multicenter, double-masked, parallel-group, vehicle-controlled studies in 805 subjects meeting a protocol-specified threshold amount of anterior chamber inflammation, LOTEMAX ointment was more effective compared to its vehicle for complete resolution of post-operative anterior chamber cell, flare, and pain following cataract surgery. Primary endpoint was complete resolution of anterior chamber cells and flare (cell count of 0 and no flare) and no pain at post-operative day 8. The individual clinical trial results are provided below.

In the 2 studies, Lotemax had statistically significant higher incidence of completely clearing of anterior chamber cells and flare at post-operative day 8 (24-32% vs. 1114%) and also had a statistically significant higher incidence of subjects that were pain free at post-operative day 8 (73-78% vs. 4145%).

Last reviewed on RxList: 6/10/2011
This monograph has been modified to include the generic and brand name in many instances.

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