Product Elements:
Desoximetasone desoximetasone desoximetasone desoximetasone cetostearyl alcohol edetate disodium isopropyl myristate lanolin alcohols mineral oil water petrolatum
Indications and Usage:
Indications and usage desoximetasone cream usp, 0.25% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Warnings:
Warnings keep out of reach of children.
General Precautions:
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. manifestation
Read more...s 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.
Dosage and Administration:
Dosage and administration apply a thin film of desoximetasone cream usp, 0.25% to the affected skin areas twice daily. rub in gently.
Contraindications:
Contraindications desoximetasone cream usp, 0.25% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
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, 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.
Overdosage:
Overdosage topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see precautions ).
Description:
Description desoximetasone cream usp, 0.25% contains the active synthetic corticosteroid desoximetasone, usp. the topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. each gram of desoximetasone cream usp, 0.25% contains 2.5 mg of desoximetasone, usp in an emollient cream base consisting of cetostearyl alcohol, edetate disodium, isopropyl myristate, lanolin alcohol, mineral oil, purified water, and white petrolatum. the chemical name of desoximetasone, usp is pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16-methyl-,(11β,16α)-. desoximetasone, usp 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: 8b7da440-figure-01
Clinical Pharmacology:
Clinical pharmacology topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions. the mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. 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. pharmacokinetics the extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. topical corticosteroids can be absorbed from normal intact skin. inflammation and/or other disease processes in the skin increase percutaneous absorption. occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. thus, occlusive dressings may be
Read more...a valuable therapeutic adjunct for treatment of resistant dermatoses. once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. corticosteroids are bound to plasma proteins in varying degrees. corticosteroids are metabolized primarily in the liver and are then 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 mcg/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.
Pharmacokinetics:
Pharmacokinetics the extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. topical corticosteroids can be absorbed from normal intact skin. inflammation and/or other disease processes in the skin increase percutaneous absorption. occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses. once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. corticosteroids are bound to plasma proteins in varying degrees. corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. some of the topical corticosteroids and their metabolites are also excreted into the bile. pharmacokinetic studies in m
Read more...en 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 mcg/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.
How Supplied:
How supplied desoximetasone cream usp, 0.25% is available as follows: 15 gram tube: ndc 71205-271-15 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] manufactured by: g&w laboratories, inc. 111 coolidge street south plainfield, nj 07080 usa distributed by: actavis pharma, inc. parsippany, nj 07054 usa relabeled by: proficient rx lp thousand oaks, ca 91320 revised - july 2015 i600-6270/71 gw 7046
Package Label Principal Display Panel:
Package label.principal display panel ndc 71205-271-15 desoximetasone cream usp, 0.25% rx only for topical use only not for oral, opthalmic, or intravaginal use keep this and all medication out of the reach of children. net wt. 15 g 71205-271-15