DESOXIMETASONE- desoximetasone cream
Rebel Distributors Corp
For external use only. Not for ophthalmic use.
Desoximetasone Cream USP, 0.05%; Desoximetasone Cream USP, 0.25% and Desoximetasone Gel USP, 0.05% contain desoximetasone a synthetic fluorinated corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and anti-pruritic agents.
Chemically, desoximetasone is Pregna-1, 4-diene-3, 20-dione, 9-fluoro-11,21-dihydroxy-16-methyl-, (11β, 16α)-. It has the molecular formula C22 H29 FO4 and a molecular weight of 376.47. The CAS Registry Number is 382-67-2. The chemical structure is:
Desoximetasone is a white to off-white, odorless, crystalline powder and is soluble in alcohol, acetone, chloroform, and hot ethyl acetate; slightly soluble in ether and benzene; and insoluble in water, dilute aqueous acids and alkalis.
Each gram of Desoximetasone Cream USP, 0.05% contains 0.5 mg of desoximetasone in an emollient cream consisting of white petrolatum, purified water, isopropyl myristate, lanolin alcohols, mineral oil, cetostearyl alcohol and edetate disodium.
Each gram of Desoximetasone Cream USP, 0.25% contains 2.5 mg of desoximetasone in an emollient cream consisting of white petrolatum, purified water, isopropyl myristate, lanolin alcohols, mineral oil and cetostearyl alcohol.
Each gram of Desoximetasone Gel USP, 0.05% contains 0.5 mg of desoximetasone in a gel base consisting of purified water, docusate sodium, edetate disodium, isopropyl myristate, carbomer 940, trolamine, and SDAG-3 95% alcohol.
The corticosteroids are a class of compounds comprising steroid hormones secreted by the adrenal cortex and their synthetic analogs. In pharmacologic doses, corticosteroids are used primarily for their anti-inflammatory and/or immunosuppressive effects.
Topical corticosteroids, such as desoximetasone, are effective in the treatment of corticosteroid-responsive dermatoses primarily because of their anti-inflammatory, antipruritic, and vasoconstrictive actions. However, while the physiologic, pharmacologic, and clinical effects of the corticosteroids are well known, the exact mechanisms of their actions in each disease are uncertain. Desoximetasone, a corticosteroid, has been shown to have topical (dermatologic) and systemic pharmacologic and metabolic effects characteristic of this class of drugs.
The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle and the integrity of the epidermal barrier, and the use of occlusive dressings.
Topical corticosteroids can be absorbed through normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids.
Once absorbed through the skin, topical corticosteroids enter pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees, are metabolized primarily in the liver and excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.
Pharmacokinetic studies in men with Desoximetasone Cream USP, 0.25% with tagged desoximetasone showed a total of 5.2% ± 2.9% excretion in urine (4.1% ± 2.3%) and feces (1.1% ± 0.6%) and no detectable level (limit of sensitivity: 0.005 µg/mL) in the blood when it was applied topically on the back followed by occlusion for 24 hours. Seven days after application, no further radioactivity was detected in urine or feces. The half-life of the material was 15 ± 2 hours (for urine) and 17 ± 2 hours (for feces) between the third and fifth trial day. Studies with other similarly structured steroids have shown that predominant metabolite reaction occurs through conjugation to form the glucuronide and sulfate ester. Studies performed with Desoximetasone Cream USP, 0.05%; Desoximetasone Cream USP, 0.25% and Desoximetasone Gel USP, 0.05% indicate that they are in the high range of potency as compared with other topical corticosteroids.
Topical corticosteroids are high potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.
Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
Desoximetasone Cream USP, 0.05%; Desoximetasone Cream USP, 0.25% and Desoximetasone Gel USP, 0.05% are not for ophthalmic use.
Keep out of reach of children.
Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment. Use of more than one corticosteroid-containing product at the same time may increase total systemic glucocorticoid exposure. (See DOSAGE AND ADMINISTRATION section.)
Patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression. This may be done by using ACTH stimulation and urinary free cortisol tests.
If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur requiring supplemental systemic corticosteroids. For information on systemic supplementation, see prescribing information for those products.
Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. (See PRECAUTIONS – Pediatric Use.)
If irritation develops, Desoximetasone Cream USP, 0.05%; Desoximetasone Cream USP, 0.25% or Desoximetasone Gel USP, 0.05% should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing.
If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of Desoximetasone Cream USP, 0.05%; Desoximetasone Cream USP, 0.25% or Desoximetasone Gel USP, 0.05% should be discontinued until the infection has been adequately controlled.
This medication should not be used on the face, underarm or groin area.
As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within two weeks, the diagnosis and therapy should be re-evaluated.
Patients using topical corticosteroids should receive the following information and instructions. This information is intended to aid in the safe and effective use of this medication. It is not a disclosure of all possible adverse or unintended effects:
- This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
- This medication should not be used for any disorder other than that for which it was prescribed.
- The treated skin area should not be bandaged, otherwise covered or wrapped, so as to be occlusive unless directed by the physician.
- Patients should report to their physician any signs of local adverse reactions.
- Other topical corticosteroid-containing products should not be used with Desoximetasone Cream USP, 0.05% or Desoximetasone Cream USP, 0.25% or Desoximetasone Gel USP, 0.05% without first talking to your physician.
- If no improvement is seen in 2 weeks, contact your physician.
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