Teracorte Special Precautions

HPA axis suppression: Systemic absorption of topical corticosteroids has produced reversible HPA axis suppression, manifestations of Cushing syndrome, hyperglycemia, and glucosuria in some patients. Conditions that 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 under occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and corticotropin stimulation tests. If HPA axis suppression is noted, make an attempt to withdraw the drug, reduce the frequency of application, or substitute a less potent steroid. Recovery of the HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental corticosteroids.
Irritation: If irritation develops, discontinue desoximetasone and institute appropriate therapy.
Skin infection: In the presence of dermatological infections, institute the use of an appropriate antifungal or antibacterial agent. If a favorable response does not occur promptly, discontinue desoximetasone until the infection has been adequately controlled.
Monitoring: A urinary-free cortisol test and corticotrophin stimulation test may be helpful in evaluating the HPA axis suppression.
Carcinogenesis: Long-term animal studies have not been performed to evaluate the carcinogenic potential of desoximetasone.
Mutagenesis: Studies to determine mutagenicity with prednisone and hydrocortisone have revealed negative results. Desoximetasone did not show potential for mutagenic activity in vitro in the Ames microbial mutagen test with or without metabolic activation.
Fertility impairment: Long-term animal studies have not been performed to evaluate the effect on fertility of desoximetasone.
Use in Children: Children may absorb proportionally larger amounts of desoximetasone and thus be more susceptible to systemic toxicity.
Children may demonstrate greater susceptibility to topical corticosteroid-induced hypothalamopituitary adrenal (HPA) axis suppression and Cushing syndrome than mature patients because of a larger skin surface area to body weight ratio. HPA axis suppression, Cushing syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to corticotrophin stimulation. Manifestation of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Administration of desoximetasone to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.
Topical administration: Safety and efficacy of topical desoximetasone in children younger than 10 years of age have not been established.