Halocort^®

Halocort^® is the preparation of Halobetasol Propionate, a synthetic corticosteroid for topicaldermatological use. 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, corticosteroidsare thought to act by the induction of phospholipase A₂ inhibitory proteins,collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potentmediators of inflammation such as prostaglandins and leukotrienes by inhibiting therelease of their common precursor arachidonic acid.

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Halocort^® is a super-high potency corticosteroid indicated for the relief of the inflammatoryand pruritic manifestations of corticosteroid-responsive dermatoses.

Apply a thin layer of Halocort^® to the affected skin once or twice daily, as directed by thephysician, and rub in gently and completely. Halocort^® is a super-high potency topical corticosteroid; therefore, treatment beyond two consecutive weeks is not recommended, andthe total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. As with other corticosteroids, therapyshould be discontinued when control is achieved. If no improvement is seen within 2 weeks,reassessment of diagnosis may be necessary. Halocort^® should not be used with occlusive dressings.
Pediatric use
Safety and effectiveness of Halocort^® in pediatric patients have not been established and use in pediatric patients under 12 years is not recommended.
Geriatric use
No overall differences in safety or effectiveness were observed between geriatric patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Pregnancy category is C. There are no adequate and well-controlled studies of the teratogenic potential of Halobetasol Propionate in pregnant women. Halobetasol Propionate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Caution should be exercised when topical Halobetasol Propionate is administered to a nursing woman.

If irritation develops, Halobetasol Propionate should discontinued and appropriate therapy instituted. Halobetasol Propionate produced HPA axis suppression when used in divided doses at 7 g perday for one week in patients with psoriasis. These effects were reversible upon discontinuation of treatment. Halobetasol Propionate should not be used in the treatment of rosacea or perioral dermatitis, and it should not be used on the face, groin, or in the axillae.

The most frequent side effects are stinging, burning or itching. Less frequently reported sideeffects are pustulation, erythema, skin atrophy, leukoderma, acne, vesicles, secondary infection, telangiectasia, urticaria, dry skin, miliaria, paresthesia, and rash.

Halobetasol Propionate is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

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Store in a cool & dry place protected from light. Keep all medicines away from the reach of children.