Halobetasol

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Halobetasol
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Aparna Vuppala, M.B.B.S. [2]

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Overview

Halobetasol is a corticosteroid that is FDA approved for the treatment of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Common adverse reactions include itching, sensation of burning of skin, stinging of skin.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

  • Use in children under 12 years of age is not recommended. As with other highly active corticosteroid, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.
Dosage
  • Apply a thin layer of halobetasol propionate cream, 0.05% to the affected skin once or twice daily, as directed by your physician, and rub in gently and completely.
  • Halobetasol propionate cream, 0.05% is a super-high potency topical corticosteroid; therefore, treatment should be limited to two weeks, and amounts greater than 50 g/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 cream, 0.05% should not be used with occlusive dressings.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Halobetasol in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Halobetasol in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Halobetasol in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Halobetasol in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Halobetasol in pediatric patients.

Contraindications

  • Halobetasol propionate cream, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Warnings

Precautions

General
  • 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 cream, 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 .
  • If irritation develops, halobetasol propionate cream, 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 cream, 0.05% should be discontinued until the infection has been adequately controlled.
  • Halobetasol propionate cream, 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.

Adverse Reactions

Clinical Trials Experience

  • In controlled clinical trials, the most frequent adverse events reported for halobetasol propionate cream, 0.05% included stinging, burning or itching in 4.4% of the patients. Less frequently reported adverse reactions were dry skin, erythema, skin atrophy, leukoderma, vesicles and rash.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Halobetasol in the drug label.

Drug Interactions

There is limited information regarding Halobetasol Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): C

  • Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.
  • Halobetasol propionate has been shown to be teratogenic in SPF rats and chinchilla-type rabbits when given systemically during gestation at doses of 0.04 to 0.1 mg/kg in rats and 0.01 mg/kg in rabbits. These doses are approximately 13, 33 and 3 times, respectively, the human topical dose of halobetasol propionate cream, 0.05%. Halobetasol propionate was embryotoxic in rabbits but not in rats.
  • Cleft palate was observed in both rats and rabbits. Omphalocele was seen in rats, but not in rabbits.
  • There are no adequate and well-controlled studies of teratogenic potential of halobetasol propionate in pregnant women. Halobetasol propionate cream, 0.05% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.


Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Halobetasol in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Halobetasol during labor and delivery.

Nursing Mothers

  • Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when halobetasol propionate cream, 0.05% is administered to a nursing woman.

Pediatric Use

  • Safety and effectiveness of halobetasol propionate cream, 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.

Geriatic Use

  • Of approximately 400 patients treated with halobetasol propionate cream, 0.05% in clinical studies, 25% were 61 years and over and 6% were 71 years and over. No overall differences in safety or effectiveness were observed between these patients and younger patients; and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Gender

There is no FDA guidance on the use of Halobetasol with respect to specific gender populations.

Race

There is no FDA guidance on the use of Halobetasol with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Halobetasol in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Halobetasol in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Halobetasol in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Halobetasol in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Topical

Monitoring

IV Compatibility

There is limited information regarding IV Compatibility of Halobetasol in the drug label.

Overdosage

  • Topically applied halobetasol propionate cream, 0.05% can be absorbed in sufficient amounts to produce systemic effects

Pharmacology

Ulobetasol.png
Halobetasol
Systematic (IUPAC) name
(6α,11β,16β)-21-chloro-6,9-difluoro-11,17-dihydroxy-16-methylpregna-1,4-diene-3,20-dione
Identifiers
CAS number 98651-66-2
ATC code D07AC21
PubChem 5311167
Chemical data
Formula C22H27ClF2O4 
Mol. mass 428.897
SMILES eMolecules & PubChem
Synonyms (6S,8S,9S,10S,11S,13S,14S,16S,17R)-17-(2-Chloroacetyl)-6,9-difluoro-11,17-dihydroxy-10,13,16-trimethyl-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-3-one
Pharmacokinetic data
Bioavailability ?
Metabolism ?
Half life ?
Excretion ?
Therapeutic considerations
Pregnancy cat.

?

Legal status
Routes ?

Mechanism of Action

Structure

  • Chemically halobetasol propionate is 21-chloro-6α, 9-difluoro-11β, 17-dihydroxy-16β-methylpregna-1, 4-diene-3-20-dione, 17-propionate, C25H31CIF2O5. It has the following structural formula:
This image is provided by the National Library of Medicine.
  • Halobetasol propionate has the molecular weight of 485. It is a white crystalline powder insoluble in water.
  • Each gram of halobetasol propionate cream, 0.05% contains 0.5 mg of halobetasol propionate in a cream base of cetyl alcohol, diazolidinyl urea, glycerin, isopropyl isostearate, isopropyl palmitate, methylchloroisothiazolinone, (and) methylisothiazolinone, steareth-21 and water.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Halobetasol in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Halobetasol in the drug label.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility
  • Long-term animal studies have not been performed to evaluate the carcinogenic potential of halobetasol propionate.
  • 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 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.

Clinical Studies

There is limited information regarding Clinical Studies of Halobetasol in the drug label.

How Supplied

  • Halobetasol propionate cream, 0.05% is supplied in the following tube sizes:
  • 15 g (NDC 45802-129-35)
  • 50 g (NDC 45802-129-32)

Storage

  • Store at 20 - 25°C (68 - 77°F) (See USP Controlled Room Temperature).

Images

Drug Images

Package and Label Display Panel

Halobetasol02.png
This image of the FDA label is provided by the National Library of Medicine.
Halobetasol03.png
This image of the FDA label is provided by the National Library of Medicine.

Patient Counseling Information

  • Patients using topical corticosteroids should receive the following information and instructions:1. The medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
  • The medication should not be used for any disorder other than that for which it was prescribed.
  • The treated skin area should not be bandaged, or otherwise covered or wrapped, so as to be occlusive unless directed by the physician.
  • Patients should report to their physician any signs of local adverse reactions.

Precautions with Alcohol

  • Alcohol-Halobetasol interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

  • Ultravate
  • Ultravate X

Look-Alike Drug Names

There is limited information regarding Halobetasol Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.


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