Halobetasol Propionate 0.05% Topical
Indications
Halobetasol Propionate 0.05% Topical is used for:
Psoriasis, Eczema, Corticosteroid-responsive dermatoses
Adult Dose
Inflammatory, Pruritic & Steroid-Responsive Dermatoses
Apply topically to affected area(s) BID
Not to exceed 50 g/week; do not use longer than 2 consecutive weeks
Child Dose
Inflammatory, Pruritic & Steroid-Responsive Dermatoses
<12 years: Safety and efficacy not established
>12 years: Apply topically to affected area(s) BID
Not to exceed 50 g/wk; do not use longer than 2 wk
Renal Dose
Administration
A thin layer should be applied to the affected skin once or twice daily and rub in gently and completely.
Contra Indications
Halobetasol Propionate Cream/Ointment is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
Precautions
Systemic absorption of topical corticosteroids may cause reversible hypothalamic-pituitaryadrenal (HPA) axis suppression, manifestations of cushing\'s syndrome, hyperglycemia, and glucosuria. Patients receiving 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 and 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.
Lactation: excretion of topical corticosteroids in breast milk is unknown; use with caution
Pregnancy-Lactation
Pregnancy
Data are unavailable for use in pregnant women to inform any drug associated risks for birth defects or miscarriage
Animal studies
Systemic administration during organogenesis to pregnant rats at 13-33 times the human topical dose and to pregnant rabbits at 3 times the human topical dose resulted in teratogenic and embryotoxic effects
Lactation
Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects in infant
Unknown whether topical corticosteroids result in sufficient systemic absorption to produce detectable quantities in human milk
Advise breastfeeding women not to apply halobetasol directly to the nipple and areola to avoid direct infant exposure
Interactions
Adverse Effects
Side effects of Halobetasol Propionate 0.05% Topical :
Skin atrophy, Striae, Acneform lesions, Intracranial hypertension, Allergic contact dermatitis, Pruritus, Pustulation, Perioral dermatitis, Urticaria, Hypertrichosis, Leukoderma, Pigmentation changes, HPA suppression (with higher potency used >2 wk)
Mechanism of Action
Corticosteroids decrease inflammation by stabilizing leukocyte lysosomal membranes, preventing release of destructive acid hydrolases from leukocytes; inhibiting macrophage accumulation in inflamed areas; reducing leukocyte adhesion to capillary endothelium; reducing capillary wall permeability and edema formation; decreasing complement components; antagonizing histamine activity and release of kinin from substrates; reducing fibroblast proliferation, collagen deposition, and subsequent scar tissue formation.