TEMOVATE E- clobetasol propionate cream
Fougera Pharmaceuticals Inc.
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use TEMOVATE® E safely and effectively. See full prescribing information for TEMOVATE® E.
TEMOVATE ® E (clobetasol propionate) cream, 0.05%, for topical use
Initial U.S. Approval: 1994
INDICATIONS AND USAGE
Temovate® E is a corticosteroid indicated for:
1.3 Limitation of Use
DOSAGE AND ADMINISTRATION
DOSAGE FORMS AND STRENGTHS
Cream: 0.05% (3)
WARNINGS AND PRECAUTIONS
To report SUSPECTED ADVERSE REACTIONS, contact PharmaDerm, A division of Fougera Pharmaceuticals Inc. at 1-800-645-9833 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION.
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
1.1 Corticosteroid-Responsive Dermatoses
1.2 Moderate to Severe Plaque-Type Psoriasis
1.3 Limitations of Use
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
5 WARNINGS AND PRECAUTIONS
5.1 Effects on the Endocrine System
5.2 Local Adverse Reactions with Topical Corticosteroids
5.3 Allergic Contact Dermatitis
5.4 Concomitant Skin Infections
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
8 USE IN SPECIFIC POPULATIONS
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
Temovate® E is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years of age and older. Treatment should be limited to 2 consecutive weeks, and the total dosage should not exceed 50 grams per week
Temovate®E is indicated for the topical treatment of moderate to severe plaque-type psoriasis. Treatment beyond 4 consecutive weeks is not recommended. Use in pediatric patients under 16 years of age is not recommended.
Temovate® E is a super-high potency topical corticosteroid; therefore, treatment should be limited to 2 consecutive weeks, and amounts greater than 50 grams per week should not be used.
Temovate® E should not be used with occlusive dressings.
Cream, 0.05%. Each gram of Temovate® E Cream contains 0.5 mg of clobetasol propionate in a white to off-white cream base.
Systemic absorption of topical corticosteroids can produce reversible HPA axis suppression with the potential for clinical glucocorticosteroid insufficiency This may occur during treatment or upon withdrawal of the topical corticosteroid. Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. 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.
Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of more potent steroids, use over large surface areas use over prolonged periods, use under occlusion, use on an altered skin barrier, and use in patients with liver failure.
Cushing's syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids.
Use of more than one corticosteroid-containing product at the same time may increase the total systemic corticosteroid exposure.
Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than noting a clinical exacerbation. Clinical diagnosis of allergic contact dermatitis can be confirmed with patch testing. If irritation develops, Temovate® E should be discontinued and appropriate therapy instituted.
In controlled trials with clobetasol propionate formulations, the following adverse reactions have been reported:burning/stinging, pruritis, irritation, erythema, folliculitis, cracking and fissuring of the skin, numbness of the fingers tenderness in the elbow, skin atrophy, and telangiectasia. The incidence of local adverse reactions reported in the trials with Temovate® E was less than 2% of patients treated with the exception of burning/stinging which occurred in 5% of treated patients.
In rabbits, clobetasol propionate was teratogenic at doses of 3 and 10 mcg/kg. These doses are approximately 0.001 and 0.003 times, respectively, the human topical dose of Temovate® E. Abnormalities seen included cleft palate, cranioschisis, and other skeletal abnormalities.
and effectiveness of Temovate® E in pediatric patients have not been established and its use in pediatric patients under 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 Temovate® E Cream 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.
Topically applied Temovate® E can be absorbed in sufficient amounts to produce systemic effects [see Warnings and Precautions (5.1)].
Temovate® E (clobetasol propionate) Cream, 0.05% 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:
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.
In a controlled clinical trial involving patients with moderate to severe plaque-type psoriasis, Temovate® E 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.
Temovate® E (clobetasol propionate) Cream, 0.05% is a white to off-white cream, supplied in 60 g tubes (NDC 10337-301-60).
Inform patients using topical corticosteroids of the following information and instructions:
a division of
Melville, NY 11747
Package Label - Principal Display Panel – 60g Tube Label
(clobetasol propionate) Cream, 0.05%
For Topical Use Only
Not for ophthalmic, oral, or intravaginal use.
clobetasol propionate cream
|Labeler - Fougera Pharmaceuticals Inc. (043838424)|