Kenacort-A Special Precautions

General: Systemic absorption of topical corticosteroids has produced reversible hypothalamicpituitaryadrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia and glucosuria in some patients.
Conditions which augment systemic absorption of topically applied corticosteroids include the application of the more potent steroids, use over large surface areas, prolonged use and addition of occlusive dressings. Therefore, patients receiving a large dose of any potent topical steroid under any condition(s) which may enhance systemic absorption, should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests and for impairment of thermal homeostasis. If any of these conditions occur, an attempt should be made to withdraw Kenacort-A, reduce the frequency of application, substitute a less potent steroid or use a sequential approach when utilizing the occlusive technique.
Recovery of HPA axis function and thermal homeostasis are generally prompt and complete upon discontinuation of Kenacort-A. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.
If irritation develops, Kenacort-A should be discontinued and appropriate therapy instituted.
Occasionally, a patient may develop a sensitivity reaction to a particular occlusive dressing material or adhesive and a substitute material may be necessary.
In the presence of dermatologic infections, the use of appropriate anti-infective therapy should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.
Topical corticosteroids may be hazardous in psoriasis for a number of reasons including rebound relapses following development of tolerance, risk of generalized pustular psoriasis and local and systemic toxicity due to impaired barrier functions of the skin. Steroids may have a place in psoriasis of the scalp and chronic plaque psoriasis of the hands and feet. Careful patient supervision is important.
Topical corticosteroids are not for ophthalmic use.
Information for Patients: Patients using topical corticosteroids should receive the following information and instruction: Topical corticosteroids are to be used as directed by the physician. Topical corticosteroids are for skin use only. Avoid contact with eyes. Patients should be advised not to use topical corticosteroid medication for any disorder than that for which it was prescribed. The treated skin area should not be bandaged, covered or wrapped unless directed by the physician. Do not use tight-fitting plastic pants/incontinence garments on patients being treated, as these garments may constitute occlusive dressing. Patients should report any signs of adverse reactions especially under occlusive dressing.
Laboratory Tests: A urinary free cortisol test and ACTH stimulation test may be helpful in evaluating HPA axis suppression.
Carcinogenicity, Mutagenicity & Impairment of Fertility: Long-term animal studies have not been performed to evaluate carcinogenic or mutagenic potential, or possible impairment of fertility in males or females.
Use in pregnancy: Teratogenic Effects: 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 skin application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on the teratogenic effects of 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 a long period of time.
Use in lactation: 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 women.
Use in children: Use of Kenacort-A over large surface areas or for long periods in children could result in sufficient systemic absorption to produce systemic effects.
Children 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 children receiving topical corticosteroids (see Adverse Reactions).
Administration of topical corticosteroids in children should be limited to the least amount for the shortest duration compatible with an effective therapeutic regimen. These patients should be closely monitored for signs and symptoms of systemic effects.