No information provided.
Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal
(HPA) axis suppression with the potential for gluco-corticosleroid 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.
Halobetasol Propionate 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 those
Pediatric patients may be more susceptible to systemic toxicity from equivalent
doses due to then larger skin surface to body mass ratios (see PRECAUTIONS:
If irritation develops. 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 dove lop, an appropriate antifungal
or anti-bacterial agent should be used. If a favorable response does not occur
promptly, use of Halobetasol Propionate Ointment should be discontinued until
the infection has been adequately controlled.
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
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 50μg/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 alter 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 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. 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 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 Halobetasol Propionate Ointment is administered to a nursing
Safety and effectiveness of 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 font-anelles, headaches, and bilateral papilledema.
Of approximately 850 patients treated with Halobetasol Propionate 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.