Hydrocortisone Acetate Pramoxine Hcl

Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

• 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 and 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 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.
• 1.
• Laboratory Tests - The following tests may be helpful in evaluating the HPA axis suppression:
• Urinary free cortisol test ACTH stimulation test Carcinogenesis, Mutagenesis, 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:
• Nursing Mothers - It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable amounts in breast milk.
• 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.
• 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 and 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 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.

• 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.
• It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable amounts 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.

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects. (See PRECAUTIONS.)