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 Topical Solution, 0.05% is administered to a nursing woman.

Pediatric Use

Use of Clobetasol Propionate Topical Solution, 0.05% in pediatric patients under 12 years of age is not recommended.

Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing syndrome than mature patients because of a larger skin surface area to body weight ratio.

HPA axis suppression, Cushing 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, headaches, and bilateral papilledema.

Geriatric Use

A limited number of patients at or above 65 years of age (n=65) have been treated with Clobetasol Propionate Topical Solution, 0.05% in US and non-US clinical trials. While the number of patients 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 patients. Based on available data, no adjustment of dosage of Clobetasol Propionate Topical Solution, 0.05% in geriatric patients is warranted.

ADVERSE REACTIONS

Clobetasol Propionate Topical Solution, 0.05% is generally well tolerated when used for 2-week treatment periods.

The most frequent adverse events reported for Clobetasol Propionate Topical Solution, 0.05% have been local and have included burning and/or stinging sensation, which occurred in 29 of 294 patients; scalp pustules, which occurred in 3 of 294 patients; and tingling and folliculitis, each of which occurred in 2 of 294 patients. Less frequent adverse events were itching and tightness of the scalp, dermatitis, tenderness, headache, hair loss, and eye irritation, each of which occurred in 1 of 294 patients.

The following local adverse reactions are reported infrequently when topical corticosteroids are used as recommended. These reactions are listed in an approximately decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria. Systemic absorption of topical corticosteroids has produced reversible HPA axis suppression, manifestations of Cushing syndrome, hyperglycemia, and glucosuria in some patients. In rare instances, treatment (or withdrawal of treatment) of psoriasis with corticosteroids is thought to have exacerbated the disease or provoked the pustular form of the disease, so careful patient supervision is recommended.

OVERDOSAGE

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

DOSAGE AND ADMINISTRATION

Clobetasol Propionate Topical Solution, 0.05% should be applied to the affected scalp areas twice daily, once in the morning and once at night.

Clobetasol Propionate Topical Solution, 0.05% is potent; therefore, treatment must be limited to 2 consecutive weeks and amounts greater than 50 mL/week should not be used.

Clobetasol Propionate Topical Solution, 0.05% is not to be used with occlusive dressings.

Geriatric Use: In studies where geriatric patients (65 years of age or older, see PRECAUTIONS) have been treated with Clobetasol Propionate Topical Solution USP, 0.05%, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.

HOW SUPPLIED

Clobetasol Propionate Topical Solution USP, 0.05% is supplied in plastic squeeze bottles, 25 mL (NDC 63646-500-25) and 50 mL (NDC 63646-500-50).

Store between 39° and 77°F (4° and 25°C). Do not use near an open flame.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Manufactured and Distributed by:
Tolmar, Inc.
Fort Collins, CO 80526

04006047 Rev. 2 09/19

PRINCIPAL DISPLAY PANEL

50 mL bottle front
(click image for full-size original)
50 mL bottle back
(click image for full-size original)
50 mL carton
(click image for full-size original)
CLOBETASOL PROPIONATE
clobetasol propionate solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63646-500
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 mL
Inactive Ingredients
Ingredient Name Strength
CARBOMER 934
ISOPROPYL ALCOHOL
WATER
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63646-500-25 1 BOTTLE in 1 CARTON contains a BOTTLE
1 25 mL in 1 BOTTLE This package is contained within the CARTON (63646-500-25)
2 NDC:63646-500-50 1 BOTTLE in 1 CARTON contains a BOTTLE
2 50 mL in 1 BOTTLE This package is contained within the CARTON (63646-500-50)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076977 02/08/2017
Labeler — TOLMAR Inc. (791156578)
Establishment
Name Address ID/FEI Operations
TOLMAR 1201 Cornerstone LLC 079112310 ANALYSIS (63646-500), LABEL (63646-500), MANUFACTURE (63646-500), PACK (63646-500)
Establishment
Name Address ID/FEI Operations
TOLMAR Inc. 791156578 ANALYSIS (63646-500), LABEL (63646-500), MANUFACTURE (63646-500), PACK (63646-500)

Revised: 09/2020 TOLMAR Inc.

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