Desoximetasone

INDICATIONS AND USAGE Desoximetasone cream USP, 0.05%, desoximetasone cream USP, 0.25%, and desoximetasone gel USP, 0.05% are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

DOSAGE AND ADMINISTRATION Apply a thin film of desoximetasone cream USP, 0.05%, desoximetasone cream USP, 0.25%, or desoximetasone gel USP, 0.05% to the affected skin areas twice daily. Rub in gently.

CONTRAINDICATIONS Desoximetasone cream USP, 0.05%, desoximetasone cream USP, 0.25%, and desoximetasone gel USP, 0.05% are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

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, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria. In controlled clinical studies the incidence of adverse reactions were low (0.8%) for desoximetasone cream USP, 0.25%, and included burning, folliculitis, and folliculo-pustular lesions. The incidence of adverse reactions were also 0.8% for desoximetasone cream USP, 0.05% and included pruritus, erythema, vesiculation, and burning sensation. The incidence of adverse reactions for desoximetasone gel USP, 0.05% was 0.3% with one subject reporting stinging and burning at the site of application.

DESCRIPTION Desoximetasone cream USP, 0.05%, desoximetasone cream USP, 0.25%, and desoximetasone gel USP, 0.05% contain the active synthetic corticosteroid desoximetasone. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Each gram of desoximetasone cream USP, 0.05% contains 0.5 mg of desoximetasone in an emollient cream base consisting of cetostearyl alcohol, edetate disodium, isopropyl myristate, lanolin alcohol, mineral oil, purified water, and white petrolatum. Each gram of desoximetasone cream USP, 0.25% contains 2.5 mg of desoximetasone in an emollient cream base consisting of cetostearyl alcohol, isopropyl myristate, lanolin alcohol, mineral oil, purified water, and white petrolatum. Each gram of desoximetasone gel USP, 0.05% contains 0.5 mg of desoximetasone in a gel base consisting of carbomer 940, docusate sodium, edetate disodium, isopropyl myristate, purified water, SDAG-3 95% alcohol, and trolamine. The chemical name of desoximetasone is Pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16-methyl-,(11ß,16α)-. Desoximetasone has the molecular formula C 22 H 29 FO 4 and a molecular weight of 376.47. The CAS Registry Number is 382-67-2. The structural formula is: Chemical Structure

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

HOW SUPPLIED Desoximetasone cream USP, 0.05% is supplied in: 15 gram (NDC 51672-1271-1), 30 gram (NDC 51672-1271-2), 60 gram (NDC 51672-1271-3), and 100 gram (NDC 51672-1271-7) tubes. Desoximetasone cream USP, 0.25% is supplied in: 15 gram (NDC 51672-1270-1), 30 gram (NDC 51672-1270-2), 60 gram (NDC 51672-1270-3), and 100 gram (NDC 51672-1270-7) tubes. Desoximetasone gel USP, 0.05% is supplied in: 15 gram (NDC 51672-1261-1), 30 gram (NDC 51672-1261-2) and 60 gram (NDC 51672-1261-3) tubes. Store at controlled room temperature between 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]