Desoximetasone

What it is used for

Desoximetasone ointment is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

How to take it

Apply a thin film of Desoximetasone Ointment USP, 0.25% to the affected skin areas twice daily. Rub in gently.

Side effects, and when to stop

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:

In controlled clinical studies the incidence of adverse reactions was low (0.3%) for desoximetasone ointment and included mild burning sensation at the site of application. To report SUSPECTED ADVERSE REACTIONS, contact Teligent Pharma, Inc. at 1-856-697-1441, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Who should not take it

Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Warnings

Desoximetasone Ointment 0.25% is not for ophthalmic use.

Keep out of reach of children.

Storing it

Store at controlled room temperature between 20°-25° C (68°-77° F), excursions permitted to 15°-30°C (59°-86°F).

Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310 PI-030-00 Rev 01/2016

General

Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of the topical corticosteroid.

Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of more potent steroids, use over large surface areas, use over prolonged periods, use under occlusion, use on an altered skin barrier, and use in patients with liver failure. An ACTH stimulation test may be helpful in evaluating patients for HPA axis suppression. If HPA axis suppression is documented, an attempt should be made to gradually withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids.

Cushing's syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids.

Use of more than one corticosteroid-containing product at the same time may increase the total systemic corticosteroid exposure.

Pediatric patients may be more susceptible to systemic toxicity from use of topical corticosteroids.