Flurandrenolide

Flurandrenolide Lotion USP, 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Shake well before using. A small quantity of Flurandrenolide Lotion USP, 0.05% should be rubbed gently into the affected area 2 or 3 times daily.

Therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.

Flurandrenolide Lotion USP, 0.05% should not be used with occlusive dressings unless directed by a physician. Tight-fitting diapers or plastic pants may constitute occlusive dressings.

The following local adverse reactions are reported infrequently with topical corticosteroids but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence:

Burning

Itching

Irritation

Dryness

Folliculitis

Hypertrichosis

Acneiform eruptions

Hypopigmentation

Perioral dermatitis

Allergic contact dermatitis

The following may occur more frequently with occlusive dressings:

Maceration of the skin

Secondary infection

Skin atrophy

Striae

Miliaria

The following adverse reactions have been identified during post approval use of flurandrenolide lotion. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Flurandrenolide Lotion USP, 0.05% is a potent corticosteroid intended for topical use. Flurandrenolide occurs as white to off-white, fluffy, crystalline powder and is odorless. Flurandrenolide is practically insoluble in water and in ether. One g dissolves in 72 mL of alcohol and in 10 mL of chloroform. The molecular weight of flurandrenolide is 436.52.

The chemical name of flurandrenolide is Pregn-4-ene-3,20-dione, 6-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis (oxy)]-, (6α, 11β, 16α)-; its empirical formula is C₂₄H₃₃FO₆. The structure is as follows:

Each mL of Flurandrenolide Lotion USP, 0.05% contains 0.5 mg (1.145 μmol) (0.05%) flurandrenolide in an oil-in-water emulsion base composed of glycerin, cetyl alcohol, stearic acid, glyceryl monostearate, mineral oil, polyoxyl 40 stearate, menthol, benzyl alcohol, and purified water.

Flurandrenolide Lotion USP, 0.05% is primarily effective because of its anti-inflammatory, antipruritic, and vasoconstrictive actions.

The mechanism of the anti-inflammatory effect of topical corticosteroids is not completely understood. 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. Corticosteroids with anti-inflammatory activity may stabilize cellular and lysosomal membranes. There is also the suggestion that the effect on the membranes of lysosomes prevents the release of proteolytic enzymes and, thus, plays a part in reducing inflammation.

Evaporation of water from the lotion vehicle produces a cooling effect, which is often desirable in the treatment of acutely inflamed or weeping lesions.