Temovate Information
Temovate (Clobetasol) Description
Temovate (Clobetasol) 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 CHClFO and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water.
Temovate (Clobetasol) 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 (Clobetasol) 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 A 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 A.
Temovate (Clobetasol) Indications And Usage
Temovate (Clobetasol) 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 per 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 (Clobetasol) E Emollient applied to 5-10% of body surface area can be used up to 4 consecutive weeks. The total dosage should not exceed 50 g per 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 (Clobetasol) E Emollient for the minimum amount of time necessary to achieve the desired results (See and ). Use in pediatric patients under 16 years of age has not been studied.
Temovate (Clobetasol) Contraindications
Temovate (Clobetasol) 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.
Temovate (Clobetasol) 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 dose 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 (Clobetasol) 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 dosing 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 ). The use of clobetasol propionate cream (emollient) for 4 consecutive weeks has not been studied in pediatric patients under 16 years of age.
If irritation develops, Temovate (Clobetasol) E Emollient should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a 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 (Clobetasol) E Emollient should be discontinued until the infection has been adequately controlled.
Temovate (Clobetasol) 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:
Laboratory Tests:
ACTH stimulation test, A.M. plasma cortisol test, Urinary free cortisol test
Carcinogenesis, Mutagenesis, 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.
Clobetasol propionate was nonmutagenic in three different test systems: the Ames test, the gene conversion assay, and the B WP2 fluctuation test.
Clobetasol propionate has not been tested for teratogenicity by this route; 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 0.33 and 0.01 times, respectively, the human topical dose of Temovate (Clobetasol) 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 0.001 and 0.003 times, respectively, the human topical dose of Temovate (Clobetasol) 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 (Clobetasol) E Emollient should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers:
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Pediatric Use:
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:
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Temovate (Clobetasol) 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 (Clobetasol) 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 (Clobetasol) 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.
Temovate (Clobetasol) Overdosage
Topically applied Temovate (Clobetasol) E Emollient can be absorbed in sufficient amounts to produce systemic effects (see ).
Temovate (Clobetasol) Dosage And Administration
Apply a thin layer of Temovate (Clobetasol) E Emollient to the affected skin areas twice daily and rub in gently and completely (see ).
Temovate (Clobetasol) E Emollient is a super-high potency topical corticosteroid; therefore,
In moderate to severe plaque-type psoriasis, Temovate (Clobetasol) 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 (Clobetasol) E Emollient should not be used with occlusive dressings.
Temovate (Clobetasol)
Temovate (Clobetasol) How Supplied
Temovate (Clobetasol) E (clobetasol propionate emollient cream) Emollient, 0.05% is supplied in 60 g tubes (NDC) 0462-0301-60)
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