- #Clobetasol propionate ointment skin#
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Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing's syndrome when they are treated with topical corticosteroids. Use in children under 12 years of age is not recommended. Pediatric Use: Safety and effectiveness of clobetasol propionate gel, cream and ointment in pediatric patients have not been established. Clobetasol propionate gel, cream and ointment should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. There are no adequate and well-controlled studies of the teratogenic potential of clobetasol propionate in pregnant women. Abnormalities seen included cleft palate, cranioschisis, and other skeletal abnormalities.
These doses are approximately 0.02 and 0.05 times, respectively, the human topical dose of clobetasol propionate gel, cream and ointment. In rabbits, clobetasol propionate was teratogenic at doses of 3 and 10 mcg/kg. Abnormalities seen included cleft palate and skeletal abnormalities. These doses are approximately 1.4 and 0.04 times, respectively, the human topical dose of clobetasol propionate gel, cream and ointment. Teratogenicity studies in mice using the subcutaneous route resulted in fetotoxicity at the highest dose tested (1 mg/kg) and teratogenicity at all dose levels tested down to 0.03 mg/kg.
Clobetasol propionate has greater teratogenic potential than steroids that are less potent. Clobetasol propionate has not been tested for teratogenicity when applied topically however, it is absorbed percutaneously, and when administered subcutaneously it was a significant teratogen in both the rabbit and mouse. Some corticosteroids have been shown to be teratogenic after dermal application to laboratory animals. Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Pregnancy: Teratogenic Effects– Pregnancy Category C. If a favorable response does not occur promptly, use of clobetasol propionate should be discontinued until the infection has been adequately controlled.Ĭlobetasol propionate gel, cream and ointment should not be used in the treatment of rosacea or perioral dermatitis and it should not be used on the face, groin, or axillae. If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used.
#Clobetasol propionate ointment Patch#
Such an observation should be corroborated with appropriate diagnostic patch testing. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation as with most topical products not containing corticosteroids. If irritation develops, clobetasol propionate should be discontinued and appropriate therapy instituted. Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios (see PRECAUTIONS: Pediatric Use). For information on systemic supplementation, see prescribing information for those products. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur requiring supplemental systemic corticosteroids. Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids. 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 corticosteroid. Patients receiving superpotent corticosteroids should not be treated for more than 2 weeks at a time and only small areas should be treated at any one time due to the increased risk of HPA suppression.
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plasma cortisol, and urinary free cortisol tests. This may be done by using the ACTH stimulation, A.M. Patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression. Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on therapy. Systemic absorption of topical corticosteroids can produce reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal from treatment. General: Clobetasol propionate is a highly potent topical corticosteroid that has been shown to suppress the HPA axis at doses as low as 2 g per day.
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