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hydrocortisone acetate gel
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Hydrocortisone Acetate 2% with Aloe is a low potency topical gel containing: Hydrocortisone Acetate 2% in a base containing:
Topical corticosteroids share anti-inflammnatory, 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.
Pharmacokilletics: The extent of percutaneous absorption of topical corticosteroids is determined by
Hydrocortisone Acetate 2% with Aloe is a topical corticosteroid and is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Topical corticosteroid products are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
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Systemic absorption of topical corticosteroids has produced reversible hypothalamicpituitary-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. In pediatric patients absorption may result in higher blood levels and thus more susceptibility to systemic toxicity. (See PRECAUTIONS-Pediatric Use). 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.
Patients using topical corticosteroids should receive the following information
The following tests may be helpful in evaluating the HPA axis suppression: Urinary free cortisol test ACTH stimulation test.
Long-term animal studies have not been performed to evaluate carcinogenic potential or the effect on fertility of topical corticosteroids.
Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled
It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on
Pediatric patients may demonstrate greater susceptibility to topical corticosteroidinduced HPA axis suppression and Cushing's Syndrome than mature patients because of a larger skin surface area to body weight ratio. Hypothalamic-pituitaIy-adrenal (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 cortisone 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.
Reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious using the least amount compatible with an effective therapeutic regimen and reflecting the greater frequency of
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 approximately ·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, Miliaria.
Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects. (See PRECAUTIONS.)
Apply to affected area 3 to 4 times daily. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.
Hydrocortisone Acetate 2% with Aloe is supplied in 43 g tubes, (NDC 60258-048-43).
Revised: 06/2010 Cypress Pharmaceutical, Inc.
Reproduced with permission of U.S. National Library of Medicine
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