Lidex Topical Solution

Name: Lidex Topical Solution

Description

Lidex solution 0.05% is intended for topical administration.  The active component is the corticosteroid fluocinonide, which is the 21-acetate ester of fluocinolone acetonide and has the chemical name pregna-1,4-diene-3,20-dione,21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(6α,11β,16α)-. It has the following chemical structure:

Lidex topical solution contains fluocinonide 0.5 mg/mL in a solution of alcohol (35%), citric acid, diisopropyl adipate, and propylene glycol. In this formulation, the active ingredient is totally in solution.

Clinical Pharmacology

Topical corticosteroids share anti-inflammatory, anti-pruritic and vasoconstrictive actions.

The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids.  There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.

Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. A significantly greater amount of fluocinonide is absorbed from the solution than from the cream or gel formulations. 

Topical corticosteroids can be absorbed from normal intact skin.  Inflammation and/or other disease processes in the skin increase percutaneous absorption.  Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids.  Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses.  (See DOSAGE AND ADMINISTRATION.) 

Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees.  Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys.  Some of the topical corticosteroids and their metabolites are also excreted into the bile.

Overdosage

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects. (See PRECAUTIONS.)

Dosage and Administration

LIDEX® (fluocinonide) topical solution 0.05% is generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition.

Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

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