In a 90-day repeat-dose toxicity study in rats, topical administration of clobetasol propionate foam at dose concentrations from % to % or from to mg/kg/day of clobetasol propionate resulted in a toxicity profile consistent with long-term exposure to corticosteroids including adrenal atrophy, histopathological changes in several organs systems indicative of severe immune suppression, and opportunistic fungal and bacterial infections. A no observable adverse effect level (NOAEL) could not be determined in this study. Although the clinical relevance of the findings in animals to humans is not clear, sustained glucocorticoid-related immune suppression may increase the risk of infection and possibly the risk for carcinogenesis.
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.
Important Safety Information for Clobex ® (clobetasol propionate) Lotion, %
Clobex ® (clobetasol propionate) Lotion, %, is not recommended for anyone younger than 18 years of age.
Clobex ® Lotion is indicated to treat steroid-responsive dermatoses. Treatment of steroid responsive dermatoses (eczema, dermatitis) should be limited to 2 weeks. Use only as directed by your physician, and do not apply to your face, underarms, or groin and avoid contact with your eyes and lips.
The total dosage should not exceed 50 g (50 mL or fl oz) per week. You should use Clobex ® Lotion only for the minimum period necessary to achieve desired results. In clinical trials, patients reported burning/stinging, skin dryness, irritation, redness, itching, skin thinning and widening of blood vessels. Because too much Lotion passing through your skin may affect your adrenal glands, do not use more than prescribed and stop using the product if you experience nausea, vomiting, fever or low blood pressure, and call you doctor. If you are pregnant, trying to get pregnant or nursing, speak to your doctor before using Clobex ® Lotion.
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