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Temovate Cream

Generic Name: clobetasol propionate
Dosage Form: cream

TEMOVATE E® (clobetasol propionate emollient cream)
Emollient, 0.05%

Rx only

FOR DERMATOLOGIC USE ONLY -

NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE

Temovate Cream Description

TEMOVATE E® (clobetasol propionate emollient cream) Emollient, 0.05% contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic 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:

Clobetasol propionate has the molecular formula C25H32ClFO5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water.

TEMOVATE E® Emollient contains: clobetasol propionate 0.5 mg/g in an emollient base of cetostearyl alcohol, isopropyl myristate, propylene glycol, cetomacrogol 1000, dimethicone 360, citric acid, sodium citrate, purified water, and imidurea as a preservative.

Temovate Cream - Clinical Pharmacology

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.

Pharmacokinetics: The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier. Occlusive dressing with hydrocortisone for up to 24 hours has not been demonstrated to increase penetration; however, occlusion of hydrocortisone for 96 hours markedly enhances penetration. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.

Studies performed with TEMOVATE E® Emollient indicate that it is in the super-high range of potency as compared with other topical corticosteroids.

Indications and Usage for Temovate Cream

TEMOVATE E® Emollient is a super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in children under 12 years of age is not recommended.

In the treatment of moderate to severe plaque-type psoriasis, TEMOVATE E® Emollient applied to 5% to 10% of body surface area can be used up to 4 consecutive weeks. The total dosage should not exceed 50 g/week. When dosing for more than 2 weeks, any additional benefits of extending treatment should be weighed against the risk of HPA suppression. Treatment beyond 4 consecutive weeks is not recommended. Patients should be instructed to use TEMOVATE E® Emollient for the minimum amount of time necessary to achieve the desired results (See PRECAUTIONS and INDICATIONS AND USAGE). Use in pediatric patients under 16 years of age has not been studied.

Contraindications

TEMOVATE E® (clobetasol propionate emollient cream) Emollient, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Precautions

General: Clobetasol propionate is a highly potent topical corticosteroid that has been shown to suppress the HPA axis at doses as low as 2 g/day.

Systemic absorption of topical corticosteroids can produce reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal from treatment. Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on therapy.

Patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression. This may be done by using the ACTH stimulation, A.M. plasma cortisol, and urinary free cortisol tests. Patients receiving super-potent corticosteroids should not be treated for more than 2 weeks at a time, and only small areas should be treated at any one time due to the increased risk of HPA suppression.

In a controlled clinical trial involving patients with moderate to severe plaque-type psoriasis, TEMOVATE E® Emollient applied to 5% to 10% of body surface area, resulted in additional benefits in the treatment of patients for 4 consecutive weeks. 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. Therefore, the additional benefits of extending treatment beyond 2 weeks should be weighed against the potential for HPA suppression. Therapy should be discontinued when control is achieved. Treatment beyond 4 consecutive weeks is not recommended.

If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur that require supplemental systemic corticosteroids. For information on systemic supplementation, see prescribing information for those products.

Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios (see PRECAUTIONS: Pediatric Use). The use of TEMOVATE E® Emollient for 4 consecutive weeks has not been studied in pediatric patients under 16 years of age.

TEMOVATE E® Emollient contains the excipient imidurea which releases traces of formaldehyde as a breakdown product. Formaldehyde may cause allergic sensitization or irritation upon contact with the skin.

If irritation develops, TEMOVATE E® Emollient should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than noting a clinical exacerbation as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing.

If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of TEMOVATE E® Emollient should be discontinued until the infection has been adequately controlled.

TEMOVATE E® Emollient should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin, or axillae.

Information for Patients: Patients using topical corticosteroids should receive the following information and instructions:

  1. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
  2. This medication should not be used for any disorder other than that for which it was prescribed.
  3. The treated skin area should not be bandaged, otherwise covered, or wrapped so as to be occlusive unless directed by the physician.
  4. Patients should report any signs of local adverse reactions to the physician.
  5. Patients should inform their physicians that they are using TEMOVATE if surgery is contemplated.
  6. This medication should not be used on the face, underarms or groin areas.
  7. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, contact the physician.

Laboratory Tests: The following tests may be helpful in evaluating patients for HPA axis suppression:

ACTH stimulation test, A.M. plasma cortisol test, Urinary free cortisol test

Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term animal studies have not been performed to evaluate the carcinogenic potential of clobetasol propionate.

Studies in the rat following subcutaneous administration at dosage levels up to 50 mg/kg/day revealed that the females exhibited an increase in the number of resorbed embryos and a decrease in the number of living fetuses at the highest dose.

Clobetasol propionate was nonmutagenic in 3 different test systems: the Ames test, the Saccharomyces cerevisiae gene conversion assay, and the E. Coli B WP2 fluctuation test.

Pregnancy:Teratogenic effects: Pregnancy Category C. 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 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 TEMOVATE E® Emollient. Abnormalities seen included cleft palate and skeletal abnormalities.

In rabbits, clobetasol propionate was teratogenic at doses of 3 and 10 mcg/kg. These doses are approximately 0.02 and 0.05 times, respectively, the human topical dose of TEMOVATE E® Emollient. Abnormalities seen included cleft palate, cranioschisis, and other skeletal abnormalities.

There are no adequate and well-controlled studies of the teratogenic potential of clobetasol propionate in pregnant women. TEMOVATE E® Emollient should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

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 TEMOVATE E® Emollient is administered to a nursing woman.

Pediatric Use: Safety and effectiveness of TEMOVATE E® Emollient in pediatric patients have not been established and its use in pediatric patients under 12 years of age is not recommended. For continued use beyond 2 consecutive weeks, the safety of TEMOVATE E® Emollient has not been studied. 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 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.

Geriatric Use: A limited number of patients at or above 65 years of age (n = 34) have been treated with TEMOVATE E® Emollient in U.S. clinical trials. While the number of patients is too small to permit separate analysis of efficacy and safety, the single adverse reaction reported in this population was similar to those reactions reportd by younger patients. Based on available data, no adjustment of dosage of TEMOVATE E® Emollient in geriatric patients is warranted.

Adverse Reactions

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® Emollient was less than 2% of patients treated with the exception of burning/stinging which occurred in 5% of treated patients.

Cushing's syndrome has been reported in infants and adults as a result of prolonged use of other 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 TEMOVATE E® Emollient. These reactions are listed in an approximately decreasing order of occurrence: dryness, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae, and miliaria.

Overdosage

Topically applied TEMOVATE E® Emollient can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).

Temovate Cream Dosage and Administration

Apply a thin layer of TEMOVATE E® (clobetasol propionate emollient cream) Emollient, 0.05% to the affected skin areas twice daily and rub in gently and completely (see INDICATIONS AND USAGE).

TEMOVATE E® Emollient 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.

In moderate to severe plaque-type psoriasis, TEMOVATE E® Emollient applied to 5% to 10% of body surface area can be used for up to 4 weeks. The total dosage should not exceed 50 g/week. When dosing for more than 2 weeks, any additional benefits of extending treatment should be weighed against the risk of HPA suppression. 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. Treatment beyond 4 consecutive weeks is not recommended. Use in pediatric patients under 16 years of age has not been studied.

TEMOVATE E® Emollient should not be used with occlusive dressings.

Geriatric Use: In studies where geriatric patients (65 years of age or older, see PRECAUTIONS) have been treated with TEMOVATE E® Emollient, safety did not differ from that in younger patients, therefore no dosage adjustment is recommended.

How is Temovate Cream Supplied

TEMOVATE E® (clobetasol propionate emollient cream) Emollient, 0.05% is supplied in 60 g tubes (NDC 0462-0301-60)

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

TEMOVATE E® Emollient should not be refrigerated.

PharmaDerm®
A division of Nycomed US Inc.
Melville, NY 11747 USA
www.pharmaderm.com

I8301B
R12/09
#154

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 60 G CONTAINER

PharmaDerm®

NDC 0462-0301-60

TEMOVATE E®

(clobetasol propionate emollient cream)

Emollient, 0.05%

For dermatologic use only —

Not for ophthalmic use

Rx only

60 g

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 60G CARTON

PharmaDerm®

NDC 0462-0301-60

TEMOVATE E®

(clobetasol propionate emollient cream)

Emollient, 0.05%

For dermatologic use only — Not for ophthalmic use.

Rx only

60 g

TEMOVATE 
clobetasol propionate cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0462-0301
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  
propylene glycol  
ceteth-20  
dimethicone 350  
citric acid monohydrate  
sodium citrate  
water  
imidurea  
Packaging
# Item Code Package Description
1 NDC:0462-0301-60 1 TUBE in 1 CARTON
1 60 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020340 06/17/1994
Labeler - PharmaDerm a division of Fougera Pharmaceuticals Inc. (043838424)
Establishment
Name Address ID/FEI Operations
Fougera Pharmaceuticals Inc. 043838424 ANALYSIS(0462-0301)
Revised: 07/2012
 
PharmaDerm a division of Fougera Pharmaceuticals Inc.
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