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Clobetasol propionate is a highly potent topical corticosteroid that has
been shown to suppress the HPA axis at doses as low as 2 g per day. Systemic absorption of topical corticosteroids has resulted in reversible HPA axis suppression,
manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some
Conditions that augment systemic absorption include the application of 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 the 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.
In the presence of dermatologic infections, 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.
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, Cormax Ointment 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.
The following tests may be helpful in evaluating 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 or the effect on fertility of topical corticosteroids.
Studies to determine mutagenicity with prednisolone have revealed negative
Teratogenic Effects: Pregnancy Category C: The more potent corticosteroids
have been shown to be teratogenic in animals after dermal application. 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 the mouse. Clobetasol propionate has greater
teratogenic potential than steroids that are less potent.
There are no adequate and well-controlled studies of the teratogenic effects
of topically applied corticosteroids, including clobetasol, in pregnant women.
Therefore, clobetasol and other topical corticosteroids should be used during
pregnancy only if the potential benefit justifies the potential risk to the
fetus, and they should not be used extensively on pregnant patients, in large
amounts, or for prolonged periods of time.
It is not known whether topical administration of corticosteroids could result
in sufficient systemic absorption to produce detectable quantities in breast
milk. Systemically administered corticosteroids are secreted into breast milk
in quantities not likely to have a deleterious effect on the infant. Nevertheless,
caution should be exercised when topical corticosteroids are prescribed for
a nursing woman.
Use of Cormax Ointment 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, and intracranial hypertension have
been reported in pediatric patients receiving topical corticosteroids. Manifestations
of adrenal suppression in pediatric patients 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.
Clinical studies of clobetasol propionate scalp application, 0.05% did not
include sufficient numbers of subjects aged 65 and over to determine whether
they respond differently from younger subjects. Other reported clinical experience
has not identified differences in responses between the elderly and younger
patients. In general, dose selection for an elderly patient should be cautious.