Following topical application of fluocinolone acetonide, especially at elevated dosage levels, systemic effects such as some adrenal suppression and weight loss have been observed.
Fluocinolone acetonide decreases edema, inflammation, erythema, infiltration and pruritus with its associated scratching and excoriation. It has been shown to have over 100 times the anti-inflammatory activity of hydrocortisone. Pharmacologyįluocinolone acetonide is chemically related to prednisolone and possesses marked anti-inflammatory properties when applied topically.
It has been selected for this formulation because of several useful properties: There is a low surface tension permitting great spreadability and penetration its drying properties make it valuable in moist areas the corticosteroid is highly soluble and stable in this vehicle and a relatively slow rate of evaporation maintains the solution state for an adequate time to allow distribution and contact with all parts of the ear. Propylene glycol is well established as being nonsensitizing, nontoxic and has antimicrobial activity. It forms crystalline salts with strong protic acids and coordinates with Lewis acids. Its basicity is slightly greater than water due to enhanced electron density at the oxygen atom. DMSO has a high dielectric constant due to the polarity of the sulfur-oxygen bond. DMSO is a solvent for many aromatic and unsaturated hydrocarbons as well as inorganic salts and nitrogen-containing compounds. It is soluble in many other compounds including ethanol, acetone, diethyl ether, glycerin, toluene, benzene and chloroform. It mixes freely with water with the evolution of heat and lowers the freezing point of aqueous solutions.
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