No information provided.
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 (of ointment)
per day. Systemic absorption of topical corticosteroids has resulted in
reversible HPA axis suppression, manifestations of Cushing's syndrome, hyperglycemia,
and glucosuria in some patients.
Conditions that augment systemic absorption include the application of the
more potent corticosteroids, use over large surface areas, prolonged use, and
the addition of occlusive dressings. Therefore, patients receiving a large dose
of a potent topical steroid applied to a large surface area should be evaluated
periodically for evidence of HPA axis suppression by using the urinary free
Cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt
should be made to withdraw trie drug, to reduce the frequency of application,
or to substitute a less potent steroid Recovery of HPA axis function is generally
prompt and complete upon discontinuation of the drug. Infrequently, signs and
symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.
Pediatric patients may absorb proportionally larger amounts of topical corticosteroids
and thus be more susceptible to systemic toxicity (see PRECAUTIONS: Pediatric
If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. Irritation is possible if TEMOVATE Scalp (clobetasol propionate scalp application) Application contacts the eye. If that should occur, immediate flushing of the eye with a large volume of water is recommended.
If the inflammatory lesion becomes infected, the use of an appropriate antifungal
or antibacterial agent should be instituted. If a favorable response does not
occur promptly, the corticosteroid should be discontinued until the infection
has been adequately controlled.
Although TEMOVATE Scalp (clobetasol propionate scalp application) Application is intended for the treatment of inflammatory
conditions of the scalp, it should be noted that certain areas of the body,
such as the face, groin, and axillae, are more prone to atrophic changes than
other areas of the body following treatment with corticosteroids. Frequent observation
of the patient is important if these areas are to be treated.
As with other potent topical corticosteroids, TEMOVATE Scalp (clobetasol propionate scalp application) Application should not be used in the treatment of rosacea and perioral dermatitis. Topical corticosteroids in general should not be used in the treatment of acne or as sole therapy in widespread plaque psoriasis.
Laboratory Tests: The following tests may be helpful in evaluating patients
for HPA axis suppression:
Urinary free Cortisol test
ACTH stimulation test
Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term animal
studies have not been performed to evaluate the carcinogenic potential of clobetasol
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 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 Scalp (clobetasol propionate scalp application) Application. 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 Scalp (clobetasol propionate scalp application) Application. 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 Scalp (clobetasol propionate scalp application) Application 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 Scalp (clobetasol propionate scalp application) Application is
administered to a nursing woman.
Pediatric Use: Use of TEMOVATE Scalp (clobetasol propionate scalp application) Application in pediatric patients
under 12 years of age is not recommended.
Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced
HPA axis suppression and Cushing's syndrome than mature patients because of
a larger skin surface area to body weight ratio.
HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed
weight gain, and intra-cranial hypertension have been reported in children receiving
topical corticosteroids. Manifestations of adrenal suppression in children include
low plasma Cortisol levels and an absence of response to ACTH stimulation. Manifestations
of intracranial hypertension include bulging fontanelles, headaches, and bilateral
Geriatric Use: A limited number of patients at or above 65 years of
age (n = 65) have been treated with TEMOVATE Scalp (clobetasol propionate scalp application) Application in US and non-US
clinical trials. While the number of patients is too small to permit separate
analysis of efficacy and safety, the adverse reactions reported in this population
were similar to those reported by younger patients. Based on available data,
no adjustment of dosage of TEMOVATE Scalp (clobetasol propionate scalp application) Application in geriatric patients