Topicort Information
Topicort (Desoximetasone) Description
Topicort (Desoximetasone) Ointment 0.25% contains 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 Topicort (Desoximetasone) Ointment 0.25% contains 2.5 mg of desoximetasone in an ointment base consisting of white petrolatum and fractionated coconut oil.
The chemical name of desoximetasone is Pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16-methyl-,(11β,16α)-.
Desoximetasone has the molecular formula CHFO and a molecular weight of 376.47. The CAS Registry Number is 382-67-2.
The structural formula is:
Topicort (Desoximetasone) 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.
Topicort (Desoximetasone) Indications And Usage
Topicort (Desoximetasone) Ointment 0.25% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Topicort (Desoximetasone) Contraindications
Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
Topicort (Desoximetasone) Warnings
Topicort (Desoximetasone) Ointment 0.25% is not for ophthalmic use.
Topicort (Desoximetasone) Precautions
Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients.
Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings.
Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation 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 steroid.
Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.
Pediatric patients may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (See ). If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.
In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.
The following tests may be helpful in evaluating the hypothalamic-pituitary-adrenal (HPA) axis suppression:
Urinary free cortisol test ACTH stimulation test
Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids.
Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results. Desoximetasone did not show potential for mutagenic activity in the Ames microbial mutagen test with or without metabolic activation.
Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio.
HPA axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in pediatric patients include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.
Administration of topical corticosteroids to pediatric patients should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of pediatric patients. Safety and effectiveness of Topicort (Desoximetasone) Ointment in pediatric patients below the age of 10 have not been established.
Topicort (Desoximetasone) 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:
In controlled clinical studies the incidence of adverse reactions was low (0.3%) for Topicort (Desoximetasone) Ointment 0.25% and consisted of development of comedones at the site of application.
Topicort (Desoximetasone) Overdosage
Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see ).
Topicort (Desoximetasone) Dosage And Administration
Apply a thin film of Topicort (Desoximetasone) Ointment 0.25% to the affected skin areas twice daily. Rub in gently.
Topicort (Desoximetasone) How Supplied
Topicort (Desoximetasone) Ointment 0.25% is supplied in 5 gram tubes for physician samples, 15 gram, 60 gram and 100 gram tubes.
Topicort (Desoximetasone)
Topicort (Desoximetasone) Principal Display Panel - G Carton
