clobetasol (Cormax, Temovate): Side Effects & Dosing
Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. It is a white to cream-colored crystalline powder insoluble in water.
Get emergency medical help if you have any of these signs of an allergic reaction: Although the risk of serious side effects is low when clobetasol topical is applied to the skin, you should be aware of side effects that can occur if the medication is absorbed into your bloodstream. Stop using this medication and call your doctor at once if you have severe irritation of any treated skin, or if you show signs of absorbing clobetasol topical through your skin, such as:.
Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. A division of Fougera Pharmaceuticals Inc. Less frequent adverse reactions were itching, skin atrophy , and cracking and fissuring of the skin.
Less frequent adverse reactions were stinging, cracking, erythema , folliculitis , numbness of fingers, skin atrophy, and telangiectasia. Cushing syndrome has been reported in infants and adults as a result of prolonged use of topical clobetasol propionate formulations.
The following additional local adverse reactions have been reported with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids. These reactions are listed in an approximately decreasing order of occurrence: Systemic absorption of topical corticosteroids can produce reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal from treatment.
Manifestations of Cushing syndrome , hyperglycemia , and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on therapy. 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.
Patients receiving super- potent 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. 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.
Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur that require supplemental systemic corticosteroids. For information on systemic supplementation, see prescribing information for those products.
Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than noting a clinical exacerbation as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing. If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. ACTH stimulation test A. Long-term animal studies have not been performed to evaluate the carcinogenic potential of clobetasol propionate.
Clobetasol propionate was nonmutagenic in 3 different test systems: Cortico-steroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticos-teroids have been shown to be teratogenic after dermal application to laboratory animals. 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.
Clobetasol propionate has greater teratogenic potential than steroids that are less potent. These doses are approximately 1. Abnormalities seen included cleft palate and skeletal abnormalities. These doses are approximately 0. Abnormalities seen included cleft palate , cranioschisis, and other skeletal abnormalities. There are no adequate and well-controlled studies of the teratogenic potential of clobetasol propionate in pregnant women.
Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous cor -ticosteroid production, or cause other untoward effects.
It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. 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 syndrome when they are treated with topical corticosteroids. They are therefore also at greater risk of adrenal insufficiency during or after withdrawal of treatment.
Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children. HPA axis suppression, Cushing syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids.
Manifestations of adrenal suppression in children include low plasma cortisol levels and an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.
While the number of patients is too small to permit separate analysis of efficacy and safety, the adverse reactions reported in this population were similar to those reported by younger patients.
Like other topical corticosteroids, clobetasol propionate has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A 2 inhibitory proteins, collectively called lipocortins.
It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor , arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.
The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier. Occlusive dressing with hydrocortisone for up to 24 hours has not been demonstrated to increase penetration; however, occlusion of hydrocortisone for 96 hours markedly enhances penetration.
Topical corticosteroids can be absorbed from normal intact skin. Patients using topical corticosteroids should receive the following information and instructions:. You are encouraged to report negative side effects of prescription drugs to the FDA. Last reviewed on RxList: Find Lowest Prices on. For Consumers What are the possible side effects of clobetasol topical? Stop using this medication and call your doctor at once if you have severe irritation of any treated skin, or if you show signs of absorbing clobetasol topical through your skin, such as: Adult Skin Problems Slideshow.
Gallery of Skin Problems and Image Collection. Nursing Mothers Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous cor -ticosteroid production, or cause other untoward effects.
Pharmacokinetics The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes. This medication should not be used for any disorder other than that for which it was prescribed.
The treated skin area should not be bandaged, otherwise covered, or wrapped so as to be occlusive unless directed by the physician. Patients should report any signs of local adverse reactions to the physician. Spring Allergies Precise Cancer Therapy.