Clobetasol Propionate (emollient) (Page 2 of 2)

8.4 Pediatric Use

Safety and effectiveness of Clobetasol propionate cream, 0.05% (emollient) in pediatric patients have not been established and its use in pediatric patients under 12 years of age is not recommended. In a study including 12 subjects ages 18 years and older with psoriasis or atopic dermatitis involving at least 30% body surface area (BSA), adrenal suppression was identified in 3 out of 12 subjects (25%) following 1 week of treatment. Four-week HPA axis suppression studies with Clobetasol propionate cream, 0.05% (emollient) in pediatric subjects have not been conducted.

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 glucocorticosteroid insufficiency during or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children.

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 absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

The use of Clobetasol propionate cream, 0.05% (emollient) for 4 consecutive weeks has not been studied in pediatric patients under 16 years of age.

8.5 Geriatric Use

Clinical studies of Clobetasol propionate cream, 0.05% (emollient) did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects.

In general, dose selection for an elderly patient should be cautious.

10 OVERDOSAGE

Topically applied Clobetasol propionate cream, 0.05% (emollient) can be absorbed in sufficient amounts to produce systemic effects [see Warnings and Precautions (5.1) ].

11 DESCRIPTION

Clobetasol propionate cream USP, 0.05% (emollient) contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity.

Chemically, clobetasol propionate is (11β,16β)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the following structural formula:

structure.jpeg
(click image for full-size original)

Clobetasol propionate has the molecular formula C25 H32 ClFO5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water.

Each gram of Clobetasol propionate cream USP, 0.05% (emollient) contains 0.5 mg of clobetasol propionate in a white to off-white cream base consisting of cetostearyl alcohol, isopropyl myristate, propylene glycol, , polyoxyl 20 cetostearyl ether, dimethicone 350, citric acid, sodium citrate, purified water, and imidurea as a preservative.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Like other topical corticosteroids, clobetasol propionate has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2 .

12.2 Pharmacodynamics

Clobetasol propionate cream, 0.05% (emollient) is in the super-high range of potency as demonstrated in a vasoconstrictor study in healthy subjects when compared with other topical corticosteroids. However, similar blanching scores do not necessarily imply therapeutic equivalence.

12.3 Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis
Long-term animal studies have not been performed to evaluate the carcinogenic potential of clobetasol propionate.

Mutagenesis
Clobetasol propionate was nonmutagenic in three different test systems: the Ames test, the Saccharomyces cerevisiae gene conversion assay, and the E. Coli B WP2 fluctuation test.

Impairment of Fertility
Studies in the rat following oral administration at dosage levels up to 50 mg/kg per day revealed no significant effect on the males. The females exhibited an increase in the number of resorbed embryos and a decrease in the number of living fetuses at the highest dose.

14 CLINICAL STUDIES

In a controlled clinical trial involving patients with moderate to severe plaque-type psoriasis, Clobetasol propionate cream, 0.05% (emollient) was applied to 5% to 10% of body surface area. In this trial, there were no clobetasol-treated patients with clinically significant decreases in morning cortisol levels after 4 weeks of treatment; however, morning cortisol levels may not identify patients with adrenal dysfunction.

16 HOW SUPPLIED/STORAGE AND HANDLING

How Supplied
Clobetasol Propionate Cream USP, 0.05% (emollient), is a white to off-white cream, supplied as follows:
NDC 0168-0301-15 15 g tube
NDC 0168-0301-30 30 g tube
NDC 0168-0301-60 60 g tube

Storage and Handling

Store between 15°C and 30°C (59°F and 86°F)

Clobetasol Propionate Cream USP, 0.05% (emollient) should not be refrigerated.

17 PATIENT COUNSELING INFORMATION

Inform patients using topical corticosteroids of the following information and instructions:

Clobetasol propionate cream, 0.05% (emollient) is for external use only. Avoid contact with the eyes.
Use as directed. Do not use Clobetasol propionate cream, 0.05% (emollient) for any disorder other than that for which it was prescribed. Do not use longer than the prescribed time period.
Do not use other corticosteroid-containing products while using Clobetasol propionate cream, 0.05% (emollient) unless directed by the physician.
The treated skin area should not be bandaged, otherwise covered, or wrapped so as to be occlusive unless directed by the physician.
Wash hands after applying the medication.
Report any signs of local or systemic adverse reactions to the physician.
Inform their physicians that they are using Clobetasol propionate cream, 0.05% (emollient) if surgery is contemplated. If you go to another doctor for illness, injury or surgery, tell the doctor you are using Clobetasol propionate cream, 0.05% (emollient).
Do not use Clobetasol propionate cream, 0.05% (emollient) on the face, underarms or groin areas.
As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, contact the physician.
Use no more than 50 grams per week of Clobetasol propionate cream, 0.05% (emollient).
Store between 59°F and 86° F (15°C and 30°C). Do not refrigerate.

Fougera Pharmaceuticals Inc.

E. FOUGERA & CO.

A division of Fougera Pharmaceuticals Inc.

Melville, New York 11747

46289070A
R07/2021
#262

Package Label — Principal Display Panel – 15g Tube Label

NDC 0168-0301-15

CLOBETASOL PROPIONATE CREAM USP, 0.05%

(EMOLLIENT)

Rx only

FOR TOPICAL USE ONLY.

NET WT 15 grams

15gtube
(click image for full-size original)

Package Label — Principal Display Panel – 15g Tube Carton

NDC 0168-0301-15

Rx only

CLOBETASOL PROPIONATE CREAM USP, 0.05%

(EMOLLIENT)

FOR TOPICAL USE ONLY.

NET WT 15 grams

15gcarton
(click image for full-size original)
CLOBETASOL PROPIONATE (EMOLLIENT)
clobetasol propionate cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0168-0301
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
cetostearyl alcohol
isopropyl myristate
POLYOXYL 20 CETOSTEARYL ETHER
dimethicone 350
citric acid monohydrate
water
imidurea
SODIUM CITRATE, UNSPECIFIED FORM
PROPYLENE GLYCOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0168-0301-15 1 TUBE in 1 CARTON contains a TUBE
1 15 g in 1 TUBE This package is contained within the CARTON (0168-0301-15)
2 NDC:0168-0301-30 1 TUBE in 1 CARTON contains a TUBE
2 30 g in 1 TUBE This package is contained within the CARTON (0168-0301-30)
3 NDC:0168-0301-60 1 TUBE in 1 CARTON contains a TUBE
3 60 g in 1 TUBE This package is contained within the CARTON (0168-0301-60)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075430 05/26/1999
Labeler — E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. (043838424)

Revised: 07/2021 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.

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