Hydrocortisone (Cream)

Hydrocortisone (Cream)

Each gram of Hydrocortisone Cream, USP 2.5% contains 25 mg of hydrocortisone in a water-washable base of cetyl alcohol, isopropyl palmitate, methylparaben, mineral oil/lanolin alcohol, propylparaben, propylene glycol, propylene glycol stearate, polysorbate 40, purified water, sorbic acid, sorbitan palmitate, stearyl alcohol and xanthan gum. Chemically, hydrocortisone is [Pregn-4-ene-3,20-dione, 11,17, 21-trihydroxy-, (11��)-] with the molecular formula (CHO) and is represented by the following structural formula: Its molecular weight is 362.47 and its CAS Registry Number is 50-23-7. The topical corticosteroids, including hydrocortisone, constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents.

dailymed-ingredient:hydrocortisone

http://www4.wiwiss.fu-berlin.de/drugbank/resource/drugs/DB00741

dailymed-ingredient:cetyl_alcohol, dailymed-ingredient:isopropyl_palmitate, dailymed-ingredient:methylparaben, dailymed-ingredient:mineral_oil/lanolin_alcohol, dailymed-ingredient:polysorbate_40, dailymed-ingredient:propylene_glycol, dailymed-ingredient:propylene_glycol_stearate, dailymed-ingredient:propylparaben, dailymed-ingredient:sorbic_acid, dailymed-ingredient:sorbitan_palmitate, dailymed-ingredient:stearyl_alcohol, dailymed-ingredient:water, dailymed-ingredient:xanthan_gum

General: 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. Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity . 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.<br/>Information for the Patient: Patients using topical corticosteroids should receive the following information and instructions:<br/>Laboratory Tests: The following tests may be helpful in evaluating the HPA axis suppression: Urinary free cortisol test ACTH stimulation test<br/>Carcinogenesis, Mutagenesis and Impairment of Fertility: 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.<br/>Pregnancy:<br/>Teratogenic Effects: Pregnancy Category C:: 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 studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.<br/>Nursing Mothers: 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 the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.<br/>Pediatric Use: 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. Hypothalamic-pituitary-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 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.

hydrocortisone

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.

http://www4.wiwiss.fu-berlin.de/dailymed/resource/organization/Vintage_Pharmaceuticals...

Hydrocortisone