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Temovate Gel

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Temovate Gel

Warnings
Precautions

WARNINGS

No information provided.

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 shoufd be treated at any one time due to the increased risk of HPA suppression.

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 and complete 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).

If irritation develops, TEMOVATE Gel (clobetasol propionate gel) 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 Gel (clobetasol propionate gel) should be discontinued until the infection has been adequately controlled.

TEMOVATE Gel (clobetasol propionate gel) should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin, or axillae.

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 mcg/kg per 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 systemicaliy 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 Gel (clobetasol propionate gel) . 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 Gel (clobetasol propionate gel) . Abnormalities seen included cleft palate, cranioschisis, and other skeletal abnormalities.

There are no adequate and welt-controlled studies of the teratogenic potential of clobetasol propionate in pregnant women. TEMOVATE Gel (clobetasol propionate gel) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers: Systemicaliy 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 Gel (clobetasol propionate gel) is administered to a nursing woman.

Pediatric Use: Safety and effectiveness of TEMOVATE Gel (clobetasol propionate gel) in children and infants have not been established; therefore, use in children under 12 years of age is not recommended. Because of a higher ratio of skin surface area to body mass, children are at a greater risk than adults of HPA axis suppression when they are treated with topical corticosteroids. They are therefore also at greater risk of adrenal insufficiency after withdrawal of treatment and of Cushing's syndrome while on treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children (see PRECAUTIONS).

HPA axis suppression, Cushing's syndrome, and intracranial hypertension have been repotted in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, 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 = 37) have been treated with TEMOVATE Gel (clobetasol propionate gel) in US clinical trials. The number of patients is too small to permit separate analysis of efficacy and safety, and no adverse events were reported in geriatric patients. Based on available data, no adjustment of dosage of TEMOVATE Gel (clobetasol propionate gel) in geriatric patients is warranted.

Last reviewed on RxList: 3/24/2008
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions
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