Halobetasol Propionate Information
Halobetasol propionate (Halobetasol propionate)
Halobetasol propionate (Halobetasol propionate) Description
Halobetasol propionate (Halobetasol propionate) ointment, 0.05% contains Halobetasol propionate (Halobetasol propionate) , a synthetic corticosteroid for topical dermatological use. The corticosteroids constitute a class of primarily synthetic steroids used topically as an anti-inflammatory and antipruritic agent.
Chemically Halobetasol propionate (Halobetasol propionate) is 21-chloro-6α, 9-difluoro-11β, 17-dihydroxy-16β-methylpregna-1, 4-diene-3-20-dione, 17-propionate, CHClFO. It has the following structural formula:
Halobetasol propionate (Halobetasol propionate) has the molecular weight of 485. It is a white crystalline powder insoluble in water.
Each gram of Halobetasol propionate (Halobetasol propionate) ointment, 0.05% contains 0.5 mg of Halobetasol propionate (Halobetasol propionate) in a base of aluminum stearate, beeswax, pentaerythritol cocoate, stearyl citrate, petrolatum, propylene glycol and sorbitan sesquioleate.
Halobetasol propionate (Halobetasol propionate) Clinical Pharmacology
Like other topical corticosteroids, Halobetasol propionate (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 A, 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 A.
Halobetasol propionate (Halobetasol propionate) Indications And Usage
Halobetasol propionate (Halobetasol propionate) ointment, 0.05% is a super-high potency corticosteroid indictated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond two consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis.
Halobetasol propionate (Halobetasol propionate) Contraindications
Halobetasol propionate (Halobetasol propionate) ointment, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
Halobetasol propionate (Halobetasol propionate) Precautions
Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment.
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. This may be done by using the ACTH stimulation, A.M. plasma cortisol, and urinary free-cortisol tests. 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.
Halobetasol propionate (Halobetasol propionate) ointment, 0.05% produced HPA axis suppression when used in divided doses at 7 grams per day for one week in patients with psoriasis. These effects were reversible upon discontinuation of treatment.
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 requiring supplemental systemic corticosteroids. For information on systemic supplementation, see prescribing information for those products.
Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios (see :
).
If irritation develops, Halobetasol propionate (Halobetasol propionate) ointment, 0.05% should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing 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. If a favorable response does not occur promptly, use of Halobetasol propionate (Halobetasol propionate) ointment, 0.05% should be discontinued until the infection has been adequately controlled.
Halobetasol propionate (Halobetasol propionate) ointment, 0.05% 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.
Long-term animal studies have not been performed to evaluate the carcinogenic potential of Halobetasol propionate (Halobetasol propionate) .
Positive mutagenicity effects were observed in two genotoxicity assays. Halobetasol propionate (Halobetasol propionate) was positive in a Chinese hamster micronucleus test, and in a mouse lymphoma gene mutation assay .
Studies in the rat following oral administration at dose levels up to 50 µg/kg/day indicated no impairment of fertility or general reproductive performance.
In other genotoxicity testing, Halobetasol propionate (Halobetasol propionate) was not found to be genotoxic in the Ames/Salmonella assay, in the sister chromatid exchange test in somatic cells of the Chinese hamster, in chromosome aberration studies of germinal and somatic cells of rodents, and in a mammalian spot test to determine point mutations.
Safety and effectiveness of Halobetasol propionate (Halobetasol propionate) ointment, 0.05% in pedriatric patients have not been established and use in pediatric patients under 12 is not recommended. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA suppression and Cushing's 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's 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.
Halobetasol propionate (Halobetasol propionate) Adverse Reactions
In controlled clinical trials, the most frequent adverse events reported for Halobetasol propionate (Halobetasol propionate) ointment, 0.05% included stinging or burning in 1.6% of the patients. Less frequently reported adverse reactions were pustulation, erythema, skin atrophy, leukoderma, acne, itching, secondary infection, telangiectasia, urticara, dry skin, miliaria, paresthesia, and rash.
The following additional local adverse reactions are reported infrequently with topical corticosteroids, and they may occur more frequently with high potency corticosteroids, such as Halobetasol propionate (Halobetasol propionate) ointment, 0.05%. These reactions are listed in an approximate decreasing order of occurrence: folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae and miliaria.
Halobetasol propionate (Halobetasol propionate) Overdosage
Topically applied Halobetasol propionate (Halobetasol propionate) ointment, 0.05% can be absorbed in sufficient amounts to produce systemic effects (see ).
Halobetasol propionate (Halobetasol propionate) Dosage And Administration
Apply a thin layer of Halobetasol propionate (Halobetasol propionate) ointment, 0.05% to the affected skin once or twice daily, as directed by your physician, and rub in gently and completely.
Halobetasol propionate (Halobetasol propionate) ointment, 0.05% is a high potency topical corticosteroid; therefore, treatment should be limited to two weeks, and amounts greater than 50g/wk should not be used. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.
Halobetasol propionate (Halobetasol propionate) ointment, 0.05% should not be used with occlusive dressings.
Halobetasol propionate (Halobetasol propionate) How Supplied
Halobetasol propionate (Halobetasol propionate) ointment, 0.05% is supplied in the following tube sizes:
15 g (NDC 45802-131-35) and 50 g (NDC 45802-131-32)
Halobetasol propionate (Halobetasol propionate)
Halobetasol propionate (Halobetasol propionate) Principal Display Panel
Halobetasol propionate (Halobetasol propionate) Ointment, 0.05%
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