Data from FDA - Curated by EPG Health - Last updated 21 December 2016

Indication(s)

1 INDICATIONS AND USAGE •Clobetasol Propionate Foam, 0.05 % (Emulsion) is a corticosteroid indicated for the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years and older.

(1.1) Limitations of Use •Avoid face, axillae, and groin.

(1.2) •Avoid use if skin atrophy is present at the treatment site.

(1.2) 1.1 Indication Clobetasol Propionate Foam, 0.05 % (Emulsion) is indicated for the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years and older.

1.2 Limitations of Use •Clobetasol Propionate Foam, 0.05 % (Emulsion) should not be applied to the face, axillae, or groin.

•Clobetasol Propionate Foam, 0.05 % (Emulsion) should not be used if there is skin atrophy at the treatment site.

•Treatment should be limited to 2 consecutive weeks and patients should not use greater than 50 grams or more than 21 capfuls per week.

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Advisory information

contraindications
4 CONTRAINDICATIONS None. None.
Adverse reactions

6 ADVERSE REACTIONS •The most common adverse reactions (incidence?

1 %) are application site atrophy and application site reaction.

(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Perrigo at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 12/2013 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug can not 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 foam, 0.05 % (emulsion) and vehicle foam, the pooled incidence of local adverse reactions in trials for atopic dermatitis and psoriasis with clobetasol propionate foam, 0.05 % (emulsion) 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.

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.

6.2 Postmarketing 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.

Usage information

Dosing and administration

2 DOSAGE AND ADMINISTRATION Clobetasol Propionate Foam, 0.05 % (Emulsion) is not for oral, ophthalmic, or intravaginal use.

Apply a thin layer of Clobetasol Propionate Foam, 0.05 % (Emulsion) to the affected area(s) twice daily, morning and evening, for up to 2 consecutive weeks; therapy should be discontinued when control has been achieved.

The maximum weekly dose should not exceed 50 g or an amount greater than 21 capfuls per week.

For proper dispensing of foam, shake the can, hold it upside down, and depress the actuator.

Dispense a small amount of foam (about a capful) and gently massage the medication into the affected areas (excluding the face, groin, and axillae) until the foam is absorbed.

Avoid contact with the eyes.

Clobetasol Propionate Foam, 0.05 % (Emulsion) is not for oral, ophthalmic, or intravaginal use.

Apply Clobetasol Propionate Foam, 0.05 % (Emulsion) to the affected area(s) twice daily, morning and evening, for up to 2 consecutive weeks.

The maximum weekly dose should not exceed 50 g.

Use in special populations

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Teratogenic Effects.

Pregnancy Category C. There are no adequate and well-controlled studies of Clobetasol Propionate Foam, 0.05 % (Emulsion) in pregnant women.

Clobetasol Propionate Foam, 0.05 % (Emulsion) 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 has not been tested for teratogenicity when applied topically; however, it 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.

Teratogenicity studies in mice using the subcutaneous route resulted in fetotoxicity at the highest dose tested (1 mg/kg) and teratogenicity at all dose levels tested down to 0.03 mg/kg.

These doses are approximately 1.4 and 0.04 times, respectively, the human topical dose of clobetasol propionate foam, 0.05 % (emulsion) based on body surface area comparisons.

Abnormalities seen included cleft palate and skeletal abnormalities.

In rabbits, clobetasol propionate was teratogenic at doses of 0.003 and 0.01 mg/kg.

These doses are approximately 0.02 and 0.05 times, respectively, the human topical dose of clobetasol propionate foam, 0.05 % (emulsion) based on body surface area comparisons.

Abnormalities seen included cleft palate, cranioschisis, and other skeletal abnormalities.

8.3 Nursing Mothers Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects.

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk.

Because many drugs are excreted in human milk, caution should be exercised when Clobetasol Propionate Foam, 0.05 % (Emulsion) is administered to a nursing woman.

If used during lactation, Clobetasol Propionate Foam, 0.05 % (Emulsion) should not be applied on the chest to avoid accidental ingestion by the infant.

8.4 Pediatric Use Use in pediatric patients younger than 12 years is not recommended because of the risk of HPA axis suppression.

After 2 weeks of twice-daily treatment with clobetasol propionate foam, 0.05 % (emulsion), 7 of 15 subjects (47 %) aged 6 to 11 years demonstrated HPA axis suppression.

The laboratory suppression was transient; in all subjects serum cortisol levels returned to normal when tested 4 weeks post-treatment.

In 92 subjects aged 12 to 17 years, safety was similar to that observed in the adult population.

Based on these data, no adjustment of dosage of Clobetasol Propionate

Foam, 0.05 % (Emulsion) in adolescent patients aged 12 to 17 years is warranted [see Warnings and Precautions (5.1)].

Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing 's syndrome when they are treated with topical corticosteroids.

They are therefore also at greater risk of adrenal insufficiency during and/or after withdrawal of treatment.

HPA axis suppression, Cushing 's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids.

Manifestations of adrenal suppression in children include low plasma cortisol levels and an absence of response to ACTH stimulation.

Manifestations of intracranial hypertension include bulging fontanelles (in infants), headaches, and bilateral papilledema.

Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen.

Chronic corticosteroid therapy may interfere with the growth and development of children.

Adverse effects, including striae, have been reported with inappropriate use of topical corticosteroids in infants and children.

8.5 Geriatric Use A limited number of subjects aged 65 years or older have been treated with clobetasol propionate foam, 0.05 % (emulsion) (n = 58) in US clinical trials.

While the number of subjects is too small to permit separate analysis of efficacy and safety, the adverse reactions reported in this population were similar to those reported by younger subjects.

Based on available data, no adjustment of dosage of Clobetasol Propionate Foam, 0.05 % (Emulsion) in geriatric patients is warranted.

Pregnancy and lactation

8.3 Nursing Mothers Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects.

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk.

Because many drugs are excreted in human milk, caution should be exercised when Clobetasol Propionate Foam, 0.05 % (Emulsion) is administered to a nursing woman.

If used during lactation, Clobetasol Propionate Foam, 0.05 % (Emulsion) should not be applied on the chest to avoid accidental ingestion by the infant.

More information

Category Value
Authorisation number ANDA201402
Orphan designation No
Product NDC 45802-637
Date Last Revised 05-09-2015
Type HUMAN PRESCRIPTION DRUG
RXCUI 861353
Marketing authorisation holder Perrigo New York Inc