Halobetasol Propionate cream & ointment are a super-high potency corticosteroid indicated for the relief of the inflammatory & pruritic manifestations of corticosteroid-responsive dermatoses.
Like other topical corticosteroids, halobetasol propionate has anti-inflammatory, antipruritic and vasoconstrictive actions. The mechanism of the anti-inflammatory activity of the topical corticosteroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 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 .
Apply a thin layer to the affected skin once or twice daily, as directed by your physician & rub in gently & completely. Halobet(Halobetasol Propionate) is a super-high potency topical corticosteroid; therefore, treatment should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Halobet should not be used with occlusive dressings.
Halobetasol Propionate is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations. Systemic absorption of topical corticosteroids has produced reversible hypothalamicpituitary- adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, & glucosuria in some patients. Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, & the addition of occlusive dressings. Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol & 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 & complete upon discontinuation of the drug. Infrequently, signs & symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.
In controlled clinical trials, the most frequent adverse events reported for Halobet included stinging, burning or itching in 4.4% of the patients. Less frequently reported adverse reactions were dry skin, erythema, skin atrophy, leukoderma, vesicles & rash. The following additional local adverse reactions are reported infrequently with topical corticosteroids, & they may occur more frequently with high potency corticosteroids, such as Halobet. These reactions are listed in an approximate decreasing order of occurrence: foluliculitis, hypertrichosis, acneiform eruptions,hypopigmentation, perioral dermatitis, allergic contact dermatitis, seconday infection, striae & miliaria.
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 & 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 quantities 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.
Store below 30°C. Keep all medicines out of reach of children.
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