No information provided.
Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal
(HPA) axis suppression with the potential for glucocorticosteroid insufficiency
after withdrawal of treatment. Manifestations of Cushing's syndrome,hyperglycemia,
and glucosuria can also be produced in some patients by systemic absorption
of topical corticosteroids while on treatment.
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.
Ultravate Ointment produced HPA axis suppression when used in divided doses
at 7 grams per day for one week in patients with psoriasis. These effects were
reversible upon discontinuation of treatment.
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 requiring supplemental systemic corticosteroids. For
information on systemic supplementation, see prescribing information for
Pediatric patients may be more susceptible to systemic toxicity from equivalent
doses due to their larger skin surface to body mass ratios (see PRECAUTIONS:
If irritation develops, Ultravate Ointment (halobetasol propionate ointment) should be discontinued and appropriate
therapy instituted.Allergic contact dermatitis with corticosteroids is usually
diagnosed by observing 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 anti-bacterial agent should be used. If a favorable response does not occur
promptly, use of Ultravate Ointment (halobetasol propionate ointment) should be discontinued until the infection
has been adequately controlled.
Ultravate Ointment (halobetasol propionate ointment) should not be used in the treatment of rosacea or perioral
dermatitis, and it should not be used on the face, groin, or in the axillae.
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 and Impairment of Fertility
Long-term animal studies have not been performed to evaluate the carcinogenic
potential of halobetasol propionate.
Positive mutagenicity effects were observed in two genotoxicity assays. Halobetasol
propionate was positive in a Chinese hamster micronucleus test, and in a mouse
lymphoma gene mutation assay in vitro.
Studies in the rat following oral administration at dose levels up to 50 µg/kg/day
indicated no impairment of fertility or general reproductive performance.
In other genotoxicity testing,halobetasol propionate was not found to be genotoxic
in the Ames/Salmonella assay, in the sister chromatid exchange test in somatic
cells of the Chinese hamster, in chromosome aberration studies of germinal and
somatic cells of rodents, and in a mammalian spot test to determine point mutations.
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 in laboratory animals.
Halobetasol propionate has been shown to be teratogenic in SPF rats and chinchilla-type
rabbits when given systemically during gestation at doses of 0.04 to 0.1 mg/kg
in rats and 0.01 mg/kg in rabbits. These doses are approximately 13,33 and 3
times, respectively, the human topical dose of Ultravate Ointment (halobetasol propionate ointment) . Halobetasol
propionate was embryotoxic in rabbits but not in rats.
Cleft palate was observed in both rats and rabbits. Omphalocele was seen in
rats, but not in rabbits.
There are no adequate and well-controlled studies of the teratogenic potential
of halobetasol propionate in pregnant women. Ultravate Ointment (halobetasol propionate ointment) should be used
during pregnancy only if the potential benefit justifies the potential risk
to the fetus.
Systemically administered corticosteroids appear in human milk and could suppress
growth, interfere with endogenous corti-costeroid 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 Ultravate Ointment (halobetasol propionate ointment) is administered to a nursing woman.
Safety and effectiveness of Ultravate Ointment (halobetasol propionate ointment) in pediatric patients have not
been established and use in pediatric patients under 12 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's 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'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 an absence of response to ACTH stimulation. Manifestations
of intracranial hypertension include bulging fontanelles, headaches, and bilateral
Of approximately 850 patients treated with Ultravate® (halobetasol propionate ointment) Ointment in clinical
studies,21% were 61 years and over and 6% were 71 years and over.No overall
differences in safety or effectiveness were observed between these patients
and younger patients; and other reported clinical experience has not identified
differences in responses between the elderly and younger patients,but greater
sensitivity of some older individuals cannot be ruled out.