FDA

Clobetasol Propionate

Approved 2 Oct 2019TopicalSpray

The FDA lists this product in 60 strengths and forms.

Indications

Clobetasol propionate spray, 0.05% is a corticosteroid indicated for the topical treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (BSA) in patients 18 years of age or older ( 1.1 ) Limitations of Use: Do not use on the face, axillae or groin.( 1.2 ) Do not use if atrophy is present at the treatment site.( 1.2 ) Do not use for rosacea or perioral dermatitis.( 1.2 )

1.1Indication

Clobetasol propionate spray, 0.05% is a super-high potent topical corticosteroid formulation indicated for the treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (BSA) in patients 18 years of age or older. Patients should be instructed to use clobetasol propionate spray, 0.05% for the minimum amount of time necessary to achieve the desired results [ see Dosage and Administration (2) ] .

Use in patients under 18 years of age is not recommended because safety has not been established and because numerically high rates of HPA axis suppression were seen with other clobetasol propionate topical formulations. [ see Use in Specific Populations (8.4) ].

1.2Limitations of Use

Clobetasol propionate spray, 0.05% should not be used on the face, axillae, or groin. Clobetasol propionate spray, 0.05% should not be used if there is atrophy at the treatment site. Clobetasol propionate spray, 0.05% should not be used in the treatment of rosacea or perioral dermatitis.

Contraindications

None. None. ( 4 )

Warnings and precautions

Clobetasol propionate is a highly potent topical corticosteroid that has been shown to suppress the HPA axis at the lowest doses tested. ( 5.1 ) Cushing's syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids. ( 5.1 ) Systemic absorption may require periodic evaluation for HPA axis suppression. Modify use if HPA axis suppression develops.

( 5.1 ) Children may be more susceptible to systemic toxicity from use of topical corticosteroids. ( 5.1 , 8.4 ) Clobetasol propionate spray may increase the risk of cataract and glaucoma. If visual symptoms occur, consider referral to an ophthalmologist. ( 5.2) Local adverse reactions with topical corticosteroids may occur more frequently with the use of occlusive dressings and higher potency corticosteroids, including clobetasol propionate.

At a glance

Brand name: Clobetasol Propionate
Route: Topical
Dosage form: Spray
Applicant: Alembic
Status: Prescription
FDA approval: 2 Oct 2019
Application: ANDA211191-001

Indications

1.1Indication

1.2Limitations of Use

Warnings and precautions

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

There are no available data on clobetasol propionate spray use in pregnant women to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Observational studies suggest an increased risk of low birthweight in infants with the maternal use of potent or very potent topical corticosteroids (see Data) . Advise pregnant women that clobetasol propionate spray may increase the risk of having a low birth weight infant and to use clobetasol propionate spray on the smallest area of skin and for the shortest duration possible.

Animal reproduction studies have not been conducted with clobetasol propionate spray. In an animal reproduction study, subcutaneous administration of clobetasol propionate to pregnant rats at doses greater than 12.5 mcg/kg/day during the period of organogenesis caused an increase in malformations (increased incidence of umbilical hernia) [see Data] . The available data do not allow calculation of relevant comparisons between the systemic exposure of clobetasol propionate in animal studies to the systemic exposure that would be expected in humans after topical use of clobetasol propionate spray.

The estimated 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 risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data Available observational studies in pregnant women did not identify a drug-associated risk of major birth defects, preterm delivery, or fetal mortality with the use of topical corticosteroids of any potency.

However, when the dispensed amount of potent or very potent topical corticosteroids exceeded 300 g during the entire pregnancy, maternal use was associated with an increased risk of low birth weight in infants. Animal Data Clobetasol propionate is absorbed percutaneously, and when administered subcutaneously it caused malformations in both the rabbit and the mouse. Clobetasol propionate has greater potential for adverse developmental effects than steroids that are less potent.

The effect of clobetasol propionate on pregnancy outcome and development of offspring was studied in the rat. Clobetasol propionate was administered subcutaneously to female rats twice daily (0, 12.5, 25, and 50 mcg/kg/day) from day 7 of presumed gestation through day 25 of lactation or day 24 presumed gestation for those rats that did not deliver a litter. The maternal no observed-adverse-effect-level (NOAEL) for clobetasol propionate was less than 12.5 mcg/kg/day due to reduced body weight gain and feed consumption during the gestation period.

The reproductive NOAEL in the dams was 25 mcg/kg/day based on prolonged delivery at 50 mcg/kg/day. The NOAEL for viability and growth in the offspring was 12.5 mcg/kg/day based on incidence of stillbirths, reductions in pup body weights on days 1 and 7 of lactation, increased pup mortality, increases in the incidence of umbilical hernia, and increases in the incidence of pups with cysts on the kidney at higher dose levels during the preweaning period.

The weights of the epididymides and testes were significantly reduced at higher dosages. Despite these changes, there were no effects on the mating and fertility of the offspring.

Adverse reactions

In controlled, clinical trials with clobetasol propionate spray, 0.05%, the most common adverse reactions (incidence > 2%) were burning, pruritus, nasopharyngitis, upper respiratory tract infection. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals, Inc. at 1-866-210-9797 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 controlled, clinical trials with clobetasol propionate spray, 0.05%, the most common adverse reaction was burning at the site of application [40% of subjects treated with clobetasol propionate spray, 0.05% and 47% of subjects treated with Spray Vehicle].

Other commonly reported adverse reactions for clobetasol propionate spray, 0.05% and Spray Vehicle, respectively, are noted in Table 1. Table 1 - Commonly Occurring Adverse Reactions (≥1% Incidence) Adverse Reaction Clobetasol Propionate 0.05% Spray (N=120) Vehicle Spray (N=120) System Organ Class General disorders and administration site conditions 50 (42%) 56 (47%) Application site burning 48 (40%) 56 (47%) Application site dryness 2 (2%) 0 (0%) Application site irritation 1 (1%) 0 (0%) Application site pain 1 (1%) 2 (2%) Application site pigmentation changes 1 (1%) 0 (0%) Application site pruritus 4 (3%) 3 (3%) Infections and infestations 17 (14%) 12 (10%) Nasopharyngitis 6 (5%) 3 (3%) Pharyngitis streptococcal 1 (1%) 0 (0%) Upper respiratory tract infection 10 (8%) 2 (2%) Skin and subcutaneous tissue disorders 4 (3%) 2 (2%) Eczema asteatotic 2 (2%) 0 (0%) Most local adverse reactions were rated as mild to moderate and they are not affected by age, race or gender.

Systemic absorption of topical corticosteroids has produced hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glycosuria in some patients.

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 clobetasol propionate spray, 0.05%. Skin: Burning, pruritus, erythema, pain, irritation, rash, peeling, urticaria, and contact dermatitis. Ophthalmic adverse reactions of blurred vision, cataracts, glaucoma, increased intraocular pressure, and central serous chorioretinopathy have been reported with the use of topical corticosteroids.

Clobetasol Propionate

Indications

1.1Indication

1.2Limitations of Use

Contraindications

Warnings and precautions

At a glance

Two medicines in one question?

Clobetasol Propionate

Indications

1.1Indication

1.2Limitations of Use

Contraindications

Warnings and precautions

At a glance

Two medicines in one question?

5.1Effects on the Endocrine System

5.2Ophthalmic Adverse Reactions Use

5.3Local Adverse Reactions with Topical Corticosteroids

5.4Allergic Contact Dermatitis

5.6Flammable Contents

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

6.1Clinical Trials Experience

6.2Postmarketing Experience

Composition

Strengths and forms

Official product information