No information provided. Please see PRECATIONS section below.
and Ointment should not be used in the treatment of rosacea or perioral dermatitis,
and should not be used on the face, groin, or axillae.
Systemic absorption of topical corticosteroids can
produce reversible HPA axis suppression with the potential for
glucocorticosteroid insufficiency after withdrawal from treatment.
Manifestations of Cushing 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.
and Ointment produced HPA axis suppression when used at doses as low as 2 g/day
for 1 week in patients with eczema.
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).
If irritation develops, TEMOVATE® Cream and Ointment 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
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®
Cream and Ointment should be discontinued until the infection has been
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/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 Category C. Cortico-steroids have been
shown to be teratogenic in laboratory animals when administered systemically at
relatively low dosage levels. Some corticos-teroids 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® Cream and Ointment. 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®
Cream and Ointment. 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® Cream and Ointment should be used during
pregnancy only if the potential benefit justifies the potential risk to the
Systemically administered corticosteroids appear in human
milk and could suppress growth, interfere with endogenous cor-ticosteroid
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® Cream or Ointment is administered to a
Safety and effectiveness of TEMOVATE® Cream and Ointment in pediatric patients have
not been established. Use in pediatric patients under 12 years of age is not
recommended. 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 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 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 an
absence of response to ACTH stimulation. Manifestations of intracranial
hypertension include bulging fontanelles, headaches, and bilateral papilledema.
A limited number of patients at or above 65 years of age
have been treated with TEMOVATE® Cream
(n = 231) and with TEMOVATE® Ointment
(n = 101) 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® Cream and Ointment in geriatric patients is