FDA

Halobetasol Propionate

Approved 11 Aug 2023TopicalAerosol, foam

The FDA lists this product in 14 strengths and forms.

Indications

Halobetasol Propionate Topical Foam is indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older. Halobetasol Propionate Topical Foam is a corticosteroid indicated for the topical treatment of plaque psoriasis in patients twelve (12) years of age and older. ( 1 )

Contraindications

None. None.

Warnings and precautions

Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression may occur, with the potential for glucocorticosteroid insufficiency during or after treatment. ( 5.1 )
Systemic effects following prolonged exposure of topical corticosteroids may also include Cushing's syndrome, hyperglycemia, and glucosuria. ( 5.1 )
Use of potent corticosteroids on large areas, for prolonged durations, under occlusive dressings, or on an altered skin barrier may increase systemic exposure. ( 5.1 )
Children may be more susceptible to systemic toxicity when treated with topical corticosteroids. ( 5.1 , 8.4 )
Local adverse reactions with topical steroids may include atrophy, striae, irritation, acneiform eruptions, hypopigmentation, and allergic contact dermatitis. Adverse reactions may be more likely to occur with occlusive use or more potent corticosteroids. ( 5.2 )
Topical corticosteroids may increase the risk of cataract and glaucoma formation. If visual symptoms occur, consider referral to an ophthalmologist for evaluation. ( 5.3 )
Initiate appropriate therapy if concomitant skin infections develop. ( 5.4 )
Flammable contents. Avoid heat, flame, or smoking during and immediately following application. ( 5.6 )

5.1Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression and Other Adverse Endocrine Effects Halobetasol Propionate Topical

Foam is a topical corticosteroid that has been shown to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Systemic effects of topical corticosteroids may include reversible HPA axis suppression, with the potential for glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of treatment of the topical corticosteroid. The potential for hypothalamic-pituitary-adrenal (HPA) suppression with Halobetasol Propionate Topical Foam was evaluated in the following studies:

Warnings and precautions

Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression may occur, with the potential for glucocorticosteroid insufficiency during or after treatment. ( 5.1 )
Systemic effects following prolonged exposure of topical corticosteroids may also include Cushing's syndrome, hyperglycemia, and glucosuria. ( 5.1 )
Use of potent corticosteroids on large areas, for prolonged durations, under occlusive dressings, or on an altered skin barrier may increase systemic exposure. ( 5.1 )
Children may be more susceptible to systemic toxicity when treated with topical corticosteroids. ( 5.1 , 8.4 )
Local adverse reactions with topical steroids may include atrophy, striae, irritation, acneiform eruptions, hypopigmentation, and allergic contact dermatitis. Adverse reactions may be more likely to occur with occlusive use or more potent corticosteroids. ( 5.2 )
Topical corticosteroids may increase the risk of cataract and glaucoma formation. If visual symptoms occur, consider referral to an ophthalmologist for evaluation. ( 5.3 )
Initiate appropriate therapy if concomitant skin infections develop. ( 5.4 )
Flammable contents. Avoid heat, flame, or smoking during and immediately following application. ( 5.6 )

5.1Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression and Other Adverse Endocrine Effects Halobetasol Propionate Topical

Adverse reactions

The following adverse reactions are discussed in greater detail in other sections of the label:

Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression and Other Adverse Endocrine Effects [see Warnings and Precautions (5.1) ]
Allergic Contact Dermatitis [see Warnings and Precautions (5.5) ] The most commonly reported adverse reactions (≥1%) are application site pain and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Padagis ® at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In randomized, multicenter, vehicle-controlled clinical trials, 351 adults with plaque psoriasis were treated with Halobetasol Propionate Topical Foam twice daily for up to two weeks (up to approximately 50 grams per week).

Table 1 presents selected adverse reactions that occurred in at least 1% of subjects. Table 1: Adverse Reactions Occurring in ≥ 1% of Subjects through Week 2 HBP Foam N=351 Vehicle Foam N=353 Adverse Reaction % % Skin atrophy (n=1) and telangiectasia (n=2) were reported with Halobetasol Propionate Topical Foam, but not with vehicle foam. Application site burning/stinging 12% 15% Application site pain 1% <1% Headache 1% <1%

6.2Postmarketing Experience Because

the reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following local adverse reactions have been reported with topical corticosteroids: folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, irritation, striae, and miliaria.

They may occur more frequently with the use of occlusive dressings and higher potency corticosteroids, such as halobetasol propionate.

Halobetasol Propionate

Indications

Contraindications

Warnings and precautions

5.1Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression and Other Adverse Endocrine Effects Halobetasol Propionate Topical

Two medicines in one question?

Halobetasol Propionate

Indications

Contraindications

Warnings and precautions

5.1Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression and Other Adverse Endocrine Effects Halobetasol Propionate Topical

Two medicines in one question?

5.2Local Adverse Reactions

5.3Ophthalmic Adverse Reactions Use

5.4Concomitant Skin Infections Use

5.5Allergic Contact Dermatitis

5.6Flammability Halobetasol Propionate Topical

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

6.1Clinical Trials Experience

6.2Postmarketing Experience Because

Composition

Strengths and forms

Official product information

At a glance