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Hydrocortisone Acetate
Overview
What is U-Cort?
Hydrocortisone Acetate Cream USP, 1% is intended for topical administration. The active component is the corticosteroid hydrocortisone acetate, which has the chemical name pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11,17-dihydroxy-11β)-. It has the following structural formula:
Each gram of the cream contains: 10 mg Hydrocortisone Acetate, USP in a water-washable cream base containing carbomer 940, cetyl alcohol, edetate disodium, isopropyl myristate, isopropyl palmitate, perfume, polypropylene 26 oleate, propylene glycol, purified water, sodium lauryl ether, sodium metabisulfite, stearic acid, trolamine, urea (10%) and xanthan gum.
What does U-Cort look like?
What are the available doses of U-Cort?
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What should I talk to my health care provider before I take U-Cort?
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How should I use U-Cort?
U-cort, (Hydrocortisone Acetate Cream USP, 1%) is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
U-cort, (Hydrocortisone Acetate Cream USP, 1%) is generally applied to the affected area as a thin film two to four times daily, depending on the severity of the condition. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropri-ate antimicrobial therapy instituted.
What interacts with U-Cort?
Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
What are the warnings of U-Cort?
The systematic approach described above is intended to reduce the likelihood that patients with unrecognized cardiovascular disease will be inadvertently exposed to sumatriptan.
What are the precautions of U-Cort?
General
Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitaryadrenal (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 additions of occlusive dressings. Therefore, patients receiving a large dose of potent topical steroids 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. (See.) If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. As with any topical corticosteroid product, prolonged use may produce atrophy of the skin and subcutaneous tissues. When used on intertriginous or flexor areas, or on the face, this may occur even with short-term use. 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.
Information for the Patient
- This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
- Patients should be advised not to use this medication for any disorder other than for which it was prescribed.
- The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician.
- Patients should report any signs of local adverse reactions especially under occlusive dressing.
- Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings.
Patients using topical corticosteroids should receive the following information and instructions:
Laboratory Tests
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The following tests may be helpful in evaluating the HPA axis suppression:
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.
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.
Nursing Mothers
It is not known whether topical corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantitieslikely to have deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.
Pediatric Use
Pediatric patients may demonstrate greater susceptibility to a topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio.
What are the side effects of U-Cort?
The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence beginning with column 1:
| Burning | Hypertrichosis |
| Maceration of the skin | Itching |
| Acneiform eruptions | Secondary infection |
| Irritation | Hypopigmentation |
| Skin atrophy | Dryness |
| Perioral dermatitis | Striae |
| Folliculitis | Allergic contact dermatitis |
| Miliaria |
What should I look out for while using U-Cort?
Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
What might happen if I take too much U-Cort?
Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects. (See.)
How should I store and handle U-Cort?
Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature). For the oral solution, use within 45 days of first opening the bottle.Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature). For the oral solution, use within 45 days of first opening the bottle.U-cort (Hydrocortisone Acetate Cream USP, 1%) is supplied in a 1 oz (28.35 g) (NDC 51672-3009-2) tube.
