Clobetasol Propionate (Page 2 of 2)

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

Pediatric Use –

Safety and effectiveness of Clobetasol Propionate Gel, 0.05% in children and infants have not been established; therefore, use in children under 12 years of age is not recommended. Because of a higher ratio of skin surface area to body mass, children are at a greater risk than adults of HPA axis suppression when they are treated with topical corticosteroids. They are therefore also at greater risk of adrenal insufficiency after withdrawal of treatment and of Cushing’s syndrome while on treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children (see PRECAUTIONS).

HPA axis suppression, Cushing’s syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Geriatric Use –

Clinical studies of clobetasol propionate gel, 0.05% in US clinical trials did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious.

ADVERSE REACTIONS

In a controlled trial with clobetasol propionate gel, 0.05%, the only reported adverse reaction that was considered to be drug related was a report of burning sensation (1.8% of treated patients).

In larger controlled clinical trials with other clobetasol propionate formulations, the most frequently reported adverse reactions have included burning, stinging, irritation, pruritus, erythema, folliculitis, cracking and fissuring of the skin, numbness of fingers, skin atrophy, and telangiectasia (all less than 2%).

Cushing’s syndrome has been reported in infants and adults as a result of prolonged use of topical clobetasol propionate formulations.

The following additional local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with super-high potency corticosteroids such as Clobetasol Propionate Gel, 0.05%. These reactions are listed in approximate decreasing order of occurrence: dryness, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, irritation, striae, and miliaria.

OVERDOSAGE

Topically applied Clobetasol Propionate Gel, 0.05% can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).

DOSAGE AND ADMINISTRATION

Apply a thin layer of Clobetasol Propionate Gel, 0.05% to the affected skin areas twice daily and rub in gently and completely (see INDICATIONS AND USAGE).

Clobetasol Propionate Gel, 0.05% is a super-high potency topical corticosteroid; therefore, treatment should be limited to 2 consecutive weeks and amounts greater than 50 g/week should not be used.

As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.

Clobetasol Propionate Gel, 0.05% should not be used with occlusive dressings.

HOW SUPPLIED

Clobetasol Propionate Gel, 0.05% is available as follows:

15 g tube (NDC 45802-925 -14)

30 g tube (NDC 45802-925 -94)

60 g tube (NDC 45802-925 -96)

STORAGE

Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Clobetasol Propionate Gel, 0.05% should not be refrigerated.

Made in Israel

Manufactured By Perrigo

Yeruham, Israel

Distributed By

Perrigo®

Allegan, MI 49010 – www.perrigo.com

Rev 01-19

: 2P100 RC J5

PRINCIPAL DISPLAY PANEL — Carton

Rx Only

Clobetasol Propionate Gel, 0.05%

For Dermatologic Use Only — Not for Ophthalmic Use

NET WT 30 g

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The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation.

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CLOBETASOL PROPIONATE
clobetasol propionate gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45802-925
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLOBETASOL PROPIONATE (CLOBETASOL) CLOBETASOL PROPIONATE 0.5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)
PROPYLENE GLYCOL
WATER
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45802-925-14 1 TUBE in 1 CARTON contains a TUBE
1 15 g in 1 TUBE This package is contained within the CARTON (45802-925-14)
2 NDC:45802-925-94 1 TUBE in 1 CARTON contains a TUBE
2 30 g in 1 TUBE This package is contained within the CARTON (45802-925-94)
3 NDC:45802-925-96 1 TUBE in 1 CARTON contains a TUBE
3 60 g in 1 TUBE This package is contained within the CARTON (45802-925-96)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075027 07/30/2008
Labeler — Padagis Israel Pharmaceuticals Ltd (600093611)

Revised: 10/2021 Padagis Israel Pharmaceuticals Ltd

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