Clobetasol Propionate: FDA label

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Indications

Clobetasol propionate emulsion foam is indicated for the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years and older. Clobetasol propionate emulsion foam is a corticosteroid indicated for the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients aged 12 years and older. ( 1 )

Warnings and precautions

Clobetasol propionate emulsion foam has been shown to suppress the HPA axis. Systemic absorption of clobetasol propionate emulsion foam may produce reversible HPA axis suppression, Cushing’s syndrome, hyperglycemia, and unmask latent diabetes. ( 5.1 )
Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. ( 5.1 )
Modify use should HPA axis suppression develop. ( 5.1 )
High potency corticosteroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, and liver failure may predispose patients to HPA axis suppression. ( 5.1 )
May increase the risk of cataract and glaucoma. If visual symptoms occur, consider referral to an ophthalmologist for evaluation. ( 5.3 )
Pediatric patients may be more susceptible to systemic toxicity when treated with topical corticosteroids. ( 5.1 , 8.4 )
The propellant in clobetasol propionate emulsion foam is flammable. Avoid fire, flame, or smoking during and immediately following application. ( 5.5 )

5.1Effects on Endocrine System

Clobetasol propionate emulsion foam has been shown to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Systemic absorption of clobetasol propionate emulsion foam has caused reversible HPA axis suppression with the potential for clinical glucocorticoid insufficiency. This may occur during treatment or upon withdrawal of the topical corticosteroid. Use of clobetasol propionate emulsion foam for longer than 2 weeks may suppress the immune system [see Nonclinical Toxicology (13.1) ].

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

There are no available data on clobetasol propionate emulsion foam use in pregnant women to inform of a drug associated risk for adverse developmental outcomes. Published data report a significantly increased risk of low birthweight with the use of greater than 300 grams of potent or very potent topical corticosteroid during a pregnancy. Advise pregnant women of the potential risk to a fetus and to use clobetasol propionate emulsion foam on the smallest area of skin and for the shortest duration possible ( see Data ).

In animal reproduction studies, increased malformations, such as cleft palate and skeletal abnormalities, were observed after subcutaneous administration of clobetasol propionate to pregnant mice and rabbits. No comparison of animal exposure with human exposure was computed. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data Multiple observational studies found no significant associations between maternal use of topical corticosteroids of any potency and congenital malformations, preterm delivery, or fetal mortality. However, when the dispensed amount of potent or very potent topical corticosteroid exceeded 300 g during the entire pregnancy, use was associated with an increase in low birth weight infants (adjusted RR, 7.74 [95% CI, 1.49 to 40.11]).

In addition, a small cohort study, in which 28 sub-Saharan women using potent topical corticosteroids (27/28 used clobetasol propionate 0.05%) for skin lightening during pregnancy, noted a higher incidence of low birth weight infants in the exposed group. The majority of exposed subjects treated large areas of the body (a mean quantity of 60 g/month [range, 12 to 170 g]) over long periods of time. Animal Data Embryofetal development studies conducted with clobetasol propionate in mice using the subcutaneous route resulted in fetotoxicity at the highest dose tested (1 mg/kg) and malformations at all dose levels tested down to 0.03 mg/kg.

Malformations seen included cleft palate and skeletal abnormalities. In an embryofetal development study in rabbits, subcutaneous administration of clobetasol propionate resulted in malformations at doses of 0.003 and 0.01 mg/kg. Malformations seen included cleft palate, cranioschisis, and other skeletal abnormalities.

Adverse reactions

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

Effects on Endocrine System [see Warnings and Precautions (5.1) ]
Ophthalmic Adverse Reactions [see Warnings and Precautions (5.3) ]
The most common adverse reactions (incidence ≥1%) are application site atrophy and application site reaction. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Glenmark Pharmaceuticals Inc., USA at 1 (888) 721-7115 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 clinical practice. In controlled clinical trials involving 821 subjects exposed to clobetasol propionate emulsion foam and vehicle foam, the pooled incidence of local adverse reactions in trials for atopic dermatitis and psoriasis with clobetasol propionate emulsion foam was 1.9% for application site atrophy and 1.6% for application site reaction.

Most local adverse events were rated as mild to moderate and they were not affected by age, race, or gender.

6.2Postmarketing Experience

Because these 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 adverse reactions have been identified during post-approval use of clobetasol formulations: erythema, pruritus, burning, alopecia, and dryness. The following additional 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 clobetasol propionate. Cushing’s syndrome has been reported in infants and adults as a result of prolonged use of topical clobetasol propionate formulations. Ophthalmic adverse reactions may include cataracts, glaucoma, increased intraocular pressure, and central serous chorioretinopathy.

Clobetasol Propionate

Indications

Contraindications

Warnings and precautions

5.1Effects on Endocrine System

Two medicines in one question?

5.2Local Adverse Reactions with Topical Corticosteroids

5.3Ophthalmic Adverse Reactions Use

5.4Concomitant Skin Infections

5.5Flammable Contents

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

6.1Clinical Trials Experience

6.2Postmarketing Experience

Composition

Strengths and forms

Official product information

At a glance

Guidelines