DERMOTIC � fluocinolone acetonide oil
Physicians Total Care, Inc.
For Otic Use Only-
Not for Ophthalmic Use
DESCRIPTION
DermOtic� Oil Ear Drops contain fluocinolone acetonide {(6?, 11?, 16?)-6,9-difluoro-11,21-dihydroxy-16,17[(1-methylethylidene)bis(oxy)]-pregna-1,4-diene-3,20-dione, cyclic 16,17 acetal with acetone}, a synthetic corticosteroid. This formulation is also marketed as Derma-Smoothe/FS� Body Oil for the treatment of atopic dermatitis and Derma-Smoothe/FS� Scalp Oil for the treatment of psoriasis of the scalp. Chemically, fluocinolone acetonide is C24 H30 F2 O6 . It has the following structural formula:
Chemical Structure
(click image for full-size original)
Fluocinolone acetonide in DermOtic� Oil has a molecular weight of 452.50. It is a white crystalline powder that is odorless, stable in light, and melts at 270�C with decomposition; soluble in alcohol, acetone and methanol; slightly soluble in chloroform; insoluble in water.
Each gram of DermOtic� Oil contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2, refined peanut oil NF and fragrances.
CLINICAL PHARMACOLOGY
Like other topical corticosteroids, fluocinolone acetonide has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2 .
Pharmacokinetics
The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle and the integrity of the epidermal barrier. Occlusion of topical corticosteroids can enhance penetration. Topical corticosteroids can be absorbed from normal intact skin. Also, inflammation and/or other disease processes in the skin can increase percutaneous absorption.
DermOtic� Oil is in the low to medium range of potency as compared with other topical corticosteroids.