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Halobetasol

Medically reviewed by Drugs.com. Last updated on Sep 18, 2023.

Pronunciation

(hal oh BAY ta sol)

Index Terms

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Cream, External, as propionate:

Ultravate: 0.05% (50 g [DSC]) [contains cetyl alcohol]

Generic: 0.05% (15 g, 50 g)

Foam, External:

Halobetasol Propionate: 0.05% (50 g) [contains benzoic acid, cetostearyl alcohol, propylene glycol]

Lexette: 0.05% (50 g) [contains benzoic acid, cetostearyl alcohol, propylene glycol]

Kit, External, as propionate:

Halac: 0.05% [DSC] [contains cetyl alcohol, methylparaben, propylene glycol, propylparaben]

Lotion, External:

Bryhali: 0.01% (60 g, 100 g) [contains edetate (edta) disodium dihydrate, methylparaben, propylparaben]

Lotion, External, as propionate:

Ultravate: 0.05% (60 mL) [contains butylparaben, cetyl alcohol, propylene glycol, propylparaben]

Ointment, External, as propionate:

Ultravate: 0.05% (50 g [DSC]) [contains propylene glycol]

Generic: 0.05% (15 g, 50 g)

Detailed Halobetasol topical dosage information

Brand Names: U.S.

Pharmacologic Category

Pharmacology

Topical corticosteroids have anti-inflammatory, antipruritic, and vasoconstrictive properties. May depress the formation, release, and activity of endogenous chemical mediators of inflammation (kinins, histamine, liposomal enzymes, prostaglandins) through the induction of phospholipase A2 inhibitory proteins (lipocortins) and sequential inhibition of the release of arachidonic acid. Halobetasol has high range potency.

Absorption

Percutaneous absorption is dependent on several factors, including epidermal integrity (intact vs abraded skin), formulation, and the use of occlusive dressings; <6% of a topically applied dose enters circulation within 96 hours

Metabolism

Primarily hepatic

Excretion

Urine

Use: Labeled Indications

Plaque psoriasis: Treatment of plaque psoriasis in patients ≥18 years of age (foam, 0.01% lotion); treatment of plaque psoriasis in patients ≥12 years of age (0.05% lotion).

Steroid-responsive dermatoses (cream and ointment): Relief of inflammatory and pruritic manifestations of corticosteroid-response dermatoses [super high potency topical corticosteroid].

Contraindications

Hypersensitivity to halobetasol or any component of the formulation

Foam, lotion: There are no contraindications listed in the manufacturer's labeling.

Canadian labeling: Additional contraindications (not in US labeling): Cream, ointment: Untreated bacterial, tubercular, and fungal skin infections; viral diseases (eg, herpes simplex, chicken pox, vaccinia)

Documentation of allergenic cross-reactivity for corticosteroids is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

Dosing: Adult

Plaque psoriasis: Topical:

Lotion 0.01%: Apply a thin layer to affected skin once daily for up to 8 weeks; total dosage should not exceed 50 g/week. Discontinue therapy when control is achieved; if no improvement is seen in 8 weeks, reassessment of diagnosis may be necessary.

Foam, lotion 0.05%: Apply a thin layer to affected skin twice daily for up to 2 weeks; total dosage should not exceed 50 g/week. Discontinue therapy when control is achieved; if no improvement is seen in 2 weeks, reassessment of diagnosis may be necessary.

Steroid-responsive dermatoses: Cream and Ointment: Topical: Apply sparingly to skin once or twice daily; treatment should not exceed 2 consecutive weeks and total dosage should not exceed 50 g/week. Discontinue therapy when control is achieved; if no improvement is seen in 2 weeks, reassessment of diagnosis may be necessary.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Plaque psoriasis: Children ≥12 years and Adolescents: Topical: Lotion 0.05% (eg, Ultravate): Apply a thin layer to affected skin twice daily for up to 2 weeks; total dosage should not exceed 50 g/week. Discontinue therapy when control is achieved; if no improvement is seen in 2 weeks, reassessment of diagnosis may be necessary.

Steroid-responsive dermatoses: Children ≥12 years and Adolescents: Topical: Cream, Ointment: 0.05%: Apply a thin layer once or twice daily; total dosage should not exceed 50 g/week. Discontinue therapy when control is achieved; if no improvement is seen in 2 weeks, reassessment of diagnosis may be necessary. Note: To decrease risk of systemic effects, only treat small areas at any one time.

Administration

Topical: For external use only; not for ophthalmic, oral, or intravaginal use; do not apply to the face, scalp, groin, or axillae. Use of occlusive dressings is not recommended unless directed by a health care provider. Apply thin film to affected area and rub in gently and completely. Wash hands after application (unless treating hands).

Storage

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C and 30°C (59°F to 86°F). Do not freeze.

Foam: Do not refrigerate. Do not expose container to heat and/or store at >49°C (>120°F). Contents are under pressure; do not puncture or incinerate.

Drug Interactions

Aldesleukin: Corticosteroids may diminish the antineoplastic effect of Aldesleukin. Avoid combination

Halobetasol topical drug interactions (more detail)

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%: Endocrine & metabolic: HPA-axis suppression (6% to 16%)

1% to 10%:

Central nervous system: Headache (1%)

Dermatologic: Stinging of the skin (≤4%), telangiectasia (≤1%)

Endocrine & metabolic: Hyperglycemia (1%)

Local: Application site burning (≤4%), application-site pruritus (≤4%), application site atrophy (1%), application-site dermatitis (1%), application site pain (1%)

Respiratory: Upper respiratory tract infection (2%)

Frequency not defined:

Central nervous system: Paresthesia

Dermatologic: Acne vulgaris, leukoderma, local dryness of skin, miliaria, pustules, secondary skin infection, urticaria

Local: Application site erythema, application site rash, application site vesicles

<1%, postmarketing, and/or case reports: Herpes zoster infection, increased blood pressure, influenza, local skin discoloration, nasopharyngitis, otitis media, pharyngitis, skin atrophy, wound

Halobetasol topical side effects (more detail)

Warnings/Precautions

Concerns related to adverse effects:

• Adrenal suppression: May cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. HPA axis suppression may lead to adrenal crisis.

• Contact dermatitis: Allergic contact dermatitis can occur and is usually diagnosed by failure to heal rather than clinical exacerbation. Discontinue therapy if contact dermatitis develops.

• Kaposi sarcoma: Prolonged treatment with corticosteroids has been associated with the development of Kaposi sarcoma (case reports); if noted, discontinuation of therapy should be considered (Goedert 2002).

• Local effects: Local adverse reactions may occur (eg, skin atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection miliaria); may be irreversible. Local adverse reactions are more likely to occur with use of higher potency corticosteroids, occlusive dressings, and/or prolonged use. If local adverse reactions develop, discontinue use and institute appropriate therapy until skin integrity is restored.

• Ocular effects: Topical corticosteroids may increase the risk of posterior subcapsular cataracts and glaucoma. Monitor for ocular symptoms. Avoid contact with eyes.

• Skin infections: Use appropriate antibacterial or antifungal agents to treat concomitant skin infections; discontinue treatment if infection does not resolve promptly.

• Systemic effects: Topical corticosteroids may be absorbed percutaneously. Absorption of topical corticosteroids may cause manifestations of Cushing's syndrome, hyperglycemia, or glycosuria. Absorption is increased by the use of occlusive dressings, application to denuded skin, or application to large surface areas.

Special populations:

• Pediatric: Children may absorb proportionally larger amounts after topical application and may be more prone to systemic effects. HPA axis suppression, intracranial hypertension, and Cushing's syndrome have been reported in children receiving topical corticosteroids. Prolonged use may affect growth velocity; growth should be routinely monitored in pediatric patients.

Dosage form specific issues:

Foam: Topical foam is flammable; avoid fire, flame, or smoking during and immediately following application.

Other warnings/precautions:

• Appropriate use: If no improvement is seen within anticipated timeframe, reassessment of diagnosis may be necessary. Do not use the cream or ointment for the treatment of perioral dermatitis or rosacea.

Monitoring Parameters

Growth in pediatric patients; signs/symptoms of HPA axis suppression/adrenal insufficiency; bacterial or fungal skin infection

Pregnancy Considerations

Systemic bioavailability of topical corticosteroids is variable (eg, integrity of skin, use of occlusion) and may be further influenced by trimester of pregnancy (Chi 2017). In general, the use of topical corticosteroids is not associated with a significant risk of adverse pregnancy outcomes. However, there may be an increased risk of low-birth-weight infants following maternal use of potent or very potent topical products, especially in high doses. Use of mild to moderate potency topical corticosteroids is preferred in pregnant females and the use of large amounts or use for prolonged periods of time should be avoided (Chi 2016; Chi 2017; Murase 2014). Also avoid areas of high percutaneous absorption (Chi 2017). The risk of stretch marks may be increased with use of topical corticosteroids (Murase 2014).

The treatment of psoriasis in pregnancy is initiated with conservative treatment as in nonpregnant females. When a topical steroid is needed, low to moderate potency corticosteroids are preferred initially. High-potency topical steroids should be used only when clearly needed and after the first trimester (Bae 2012).

Patient Education

What is this drug used for?

• It is used to treat skin irritation.

• It is used to treat skin rashes.

• It is used to treat plaque psoriasis.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dry skin

• Burning

• Itching

• Stinging

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• High blood sugar like confusion, fatigue, increased thirst, increased hunger, passing a lot of urine, flushing, fast breathing, or breath that smells like fruit

• Cushing syndrome like weight gain in upper back or abdomen; moon face; severe headache; or slow healing

• Adrenal gland problems like severe nausea, vomiting, severe dizziness, passing out, muscle weakness, severe fatigue, mood changes, lack of appetite, or weight loss

• Skin changes like acne, stretch marks, slow healing, or hair growth

• Skin thinning

• Vision changes

• Severe skin irritation

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Frequently asked questions

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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