Flurandrenolide

Description

DESCRIPTION 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 C 24 H 33 FO 6 . 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. Chemical Structure

What Is Flurandrenolide Used For?

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

Dosage and Administration

DOSAGE AND ADMINISTRATION 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.

Side Effects (Adverse Reactions)

ADVERSE REACTIONS 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 Postmarketing Adverse Reactions 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. Skin : skin striae, hypersensitivity, skin atrophy, contact dermatitis, and skin discoloration.

Contraindications

CONTRAINDICATIONS Topical corticosteroids are contraindicated in patients with a history of hypersensitivity to any of the components of these preparations.

Pregnancy and Breastfeeding

Usage in Pregnancy - Pregnancy Category C - Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent cortico-steroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively for pregnant patients or in large amounts or for prolonged periods of time.

Nursing Mothers - It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.

Overdosage

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

How Supplied

HOW SUPPLIED Flurandrenolide Lotion USP, 0.05% is supplied in plastic squeeze bottles as follows: 60 mL (NDC 45802- 928 -02) 120 mL (NDC 45802- 928 -03) Keep out of reach of children. Storage: Avoid freezing. Keep tightly closed. Protect from light. Store at 20° to 25°C (68° to 77°F) with excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Rx Only Manufactured By Padagis Yeruham, Israel Distributed By Padagis Allegan, MI 49010