Version May 2024
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 a thin layer to affected 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.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
(For additional information see "Halobetasol: Pediatric drug information")
Plaque psoriasis: Children ≥12 years and Adolescents: Topical: 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: 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.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%:
Dermatologic: Stinging of the skin (application site; ≤12%)
Endocrine & metabolic: HPA-axis suppression (6% to 26%)
Local: Application site burning (≤12%)
1% to 10%:
Dermatologic: Telangiectasia (≤1%)
Endocrine & metabolic: Hyperglycemia (1%)
Local: Application site atrophy (≤1%), application-site dermatitis (1%), application site pain (1%), application-site pruritus (≤4%)
Nervous system: Headache (1%)
Respiratory: Upper respiratory tract infection (2%)
<1%:
Cardiovascular: Increased blood pressure
Infection: Herpes zoster infection, influenza
Local: Local skin discoloration (application site)
Otic: Otitis media
Respiratory: Nasopharyngitis, pharyngitis
Miscellaneous: Wound
Frequency not defined:
Dermatologic: Acne vulgaris, erythema of skin, leukoderma, miliaria, pruritus, pustules, secondary skin infection, skin rash, skin vesicle, urticaria, xeroderma
Nervous system: Paresthesia
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): Hypersensitivity to other corticosteroids; untreated bacterial, tubercular, and fungal skin infections; viral diseases (eg, herpes simplex, chicken pox, vaccinia).
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.
Topical corticosteroids may be absorbed percutaneously. The extent of absorption is dependent on several factors, including epidermal integrity (intact vs abraded skin), formulation, age of the patient, prolonged duration of use, and the use of occlusive dressings. Percutaneous absorption of topical steroids is increased in neonates (especially preterm neonates), infants, and young children. Hypothalamic-pituitary-adrenal (HPA) suppression may occur, particularly in younger children or in patients receiving high doses for prolonged periods; acute adrenal insufficiency (adrenal crisis) may occur with abrupt withdrawal after long-term therapy or with stress. Infants and small children may be more susceptible to HPA axis suppression or other systemic toxicities due to larger skin surface area to body mass ratio; use with caution in pediatric patients.
Some dosage forms may contain propylene glycol; in neonates, large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Shehab 2009).
Halobetasol external kit contains halobetasol propionate ointment and is packaged with ammonium lactate 12% lotion.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Cream, External, as propionate:
Generic: 0.05% (15 g, 50 g)
Foam, External:
Lexette: 0.05% (50 g) [contains benzoic acid, cetostearyl alcohol, propylene glycol]
Generic: 0.05% (50 g)
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:
Generic: 0.05% (15 g, 50 g)
May be product dependent
Cream (Halobetasol Propionate External)
0.05% (per gram): $2.64 - $5.31
Foam (Halobetasol Propionate External)
0.05% (per gram): $19.88
Foam (Lexette External)
0.05% (per gram): $21.28
Lotion (Bryhali External)
0.01% (per gram): $6.42
Lotion (Ultravate External)
0.05% (per mL): $18.32
Ointment (Halobetasol Propionate External)
0.05% (per gram): $5.31 - $7.39
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Cream, External, as propionate:
Ultravate: 0.05% (15 g, 50 g) [contains cetyl alcohol, methylchloroisothiazolinone, methylisothiazolinone]
Lotion, External:
Bryhali: 0.01% (3 g, 45 g, 60 g, 100 g) [contains edetate (edta) disodium dihydrate, methylparaben, propylparaben]
Ointment, External, as propionate:
Ultravate: 0.05% (15 g, 50 g) [contains propylene glycol]
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).
Foam: Shake prior to use.
Topical: For external use only; not for ophthalmic, oral, or intravaginal use; do not apply to face, scalp, axillae, or groin area; avoid contact with eyes. Apply sparingly to affected area; rub in gently and completely. Do not use with occlusive dressings unless directed by health care provider. Wash hands after application (unless treating hands).
Foam: Shake prior to use.
Plaque psoriasis: Treatment of plaque psoriasis in patients ≥18 years of age (foam [generic], 0.01% lotion); treatment of plaque psoriasis in patients ≥12 years of age (foam [Lexette], 0.05% lotion).
Steroid-responsive dermatoses (cream and ointment): Relief of inflammatory and pruritic manifestations of corticosteroid-response dermatoses [super high potency topical corticosteroid].
Ultravate may be confused with Cutivate
KIDs List: Medium, high, and very high potency topical corticosteroids, when used in neonates and infants <1 year of age for diaper dermatitis, are identified on the Key Potentially Inappropriate Drugs in Pediatrics (KIDs) list; use should be avoided due to risk of adrenal suppression; systemic absorption is higher in pediatric patients than adults (strong recommendation; low quality of evidence) (PPA [Meyers 2020]).
None known.
There are no known significant interactions.
Topical corticosteroids may be used for the treatment of corticosteroid-responsive dermatosis, such as atopic dermatitis, in patients planning a pregnancy (Vestergaard 2019).
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, although this risk is likely to be low (Andersson 2021; Chi 2015; Chi 2017).
When first-line treatments, such as emollients, are insufficient, topical corticosteroids may be used for the treatment of atopic dermatitis in pregnant patients (Vestergaard 2019). Topical corticosteroids are classified by potency; the medication and formulation (eg, cream, gel, and/or salt form) contribute to the potency classification (Oakley 2021; Stacey 2021; Tadicherla 2009). In general, use of the least potent product in limited amounts is recommended during pregnancy. Mild to moderate potency corticosteroids are preferred; potent to very potent topical corticosteroids should only be used as alternative therapy in limited amounts under obstetrical care. Pregnant patients should avoid application of topical corticosteroids to areas with high percutaneous absorption (eg, arm pit, skin folds, vulva) (Chi 2017), and caution should be used when applying to areas prone to striae formation (eg, abdomen, breast, thighs) (Vestergaard 2019).
It is not known if sufficient quantities of halobetasol are absorbed following topical administration to produce detectable amounts in breast milk. However, systemic corticosteroids are present in breast milk.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother. In general, topical corticosteroids are considered acceptable for use in patients who are breastfeeding (Butler 2014; WHO 2002).
Avoid application of topical corticosteroids to the nipple and areola area until breastfeeding ceases; hypertension was noted in a breastfed infant when a high-potency topical corticosteroid was applied to the nipple (AAD-NPF [Elmets 2021]; Butler 2014; Leachman 2006). If needed, apply topical corticosteroids immediately after breastfeeding, then clean nipples prior to the next feeding (Vestergaard 2019).
Growth in pediatric patients; signs/symptoms of HPA axis suppression/adrenal insufficiency; bacterial or fungal skin infection
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
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