FDA

Clobetasol Propionate

Approved 24 Sept 2019TopicalLotion

The FDA lists this product in 60 strengths and forms.

Indications

Clobetasol propionate lotion, 0.05% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses, 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 lotion, 0.05% is a super-high potent topical corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses only in patients 18 years of age or older. Treatment should be limited to 2 consecutive weeks. For moderate to severe plaque psoriasis, treatment may be extended for an additional 2 weeks for localized lesions (less than 10% body surface area) that have not sufficiently improved after the initial 2 week treatment.

Any additional benefits of extending treatment should be weighed against the risk of hypothalamic-pituitary-adrenal (HPA) axis suppression before prescribing for more than 2 weeks. The total dosage should not exceed 50 g (50 mL or 1.75 fl. oz) per week. Patients should be instructed to use clobetasol propionate lotion, 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 due to numerically high rates of HPA axis suppression [ see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.4 )].

1.2Limitations of Use

Clobetasol propionate lotion, 0.05% should not be used on the face, axillae, or groin and should not be used if there is atrophy at the treatment site. Clobetasol propionate lotion, 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 hypothalamic-pituitary- adrenal (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.

At a glance

Brand name: Clobetasol Propionate
Route: Topical
Dosage form: Lotion
Applicant: Zydus Lifesciences
Status: Prescription
FDA approval: 24 Sept 2019
Application: ANDA205249-001

Indications

1.1Indication

Use in patients under 18 years of age is not recommended due to numerically high rates of HPA axis suppression [ see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.4 )].

1.2Limitations of Use

Warnings and precautions

Pregnancy and breastfeeding

8.1Pregnancy Teratogenic Effects: Pregnancy Category C:

There are no adequate and well-controlled studies in pregnant women. Therefore, clobetasol propionate lotion, 0.05% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application to laboratory animals.

Clobetasol propionate is absorbed percutaneously, and when administered subcutaneously it was a significant teratogen in both the rabbit and the mouse. Clobetasol propionate has greater teratogenic potential 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-effect level (NOEL) 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 NOEL in the dams was 25 mcg/kg/day (ratio of animal dose to proposed human dose of 0.07 on a mg/m 2 /day basis) based on prolonged delivery at a higher dose level. The no-observed-adverse-effect-level (NOAEL) for viability and growth in the offspring was 12.5 mcg/kg/day (ratio of animal dose to proposed human dose of 0.03 on a mg/m 2 /day basis) 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

The most common adverse reactions (incidence > 1%) are skin atrophy, telangiectasia, discomfort skin and skin dry ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Viona Pharmaceuticals Inc. at 1-888-304-5011 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 lotion, 0.05%, the following adverse reactions have been reported: burning/stinging, skin dryness, irritation, erythema, folliculitis, pruritus, skin atrophy, and telangiectasia.

The pooled incidence of local adverse reactions in trials for psoriasis and atopic dermatitis with clobetasol propionate lotion, 0.05% at 1% or greater was: Table 1: Adverse Reactions with Incidence ≥ 1% in Clinical Trials Adverse Reaction Incidence Skin Atrophy 4.2% Telangiectasia 3.2% Discomfort Skin 1.3% Skin Dry 1% Most local adverse events 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 glucosuria 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 of clobetasol propionate lotion, 0.05%. Endocrine disorders: Cushing's syndrome, Adrenal suppression Skin: Rash, Pain of skin, Skin exfoliation, Skin chapped, Scaling, Induration/papulation, Lichenification.

Other: Psoriasis (aggravation), Plaque elevation, Excoriation.

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

5.2Local Adverse Reactions with Topical Corticosteroids

5.3Allergic Contact Dermatitis

Pregnancy and breastfeeding

8.1Pregnancy Teratogenic Effects: Pregnancy Category C:

Adverse reactions

6.1Clinical Trials Experience

6.2Postmarketing Experience

Composition

Strengths and forms

Official product information