A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Topicort Warnings, Precautions, Pregnancy, Nursing, Abuse - Desoximetasone
Topicort Warnings, Precautions, Pregnancy, Nursing, Abuse - Desoximetasone
WARNINGS
Topicort® (desoximetasone) Emollient Cream 0.25%
and Topicort® LP (desoximetasone) Emollient Cream 0.05% are not
for ophthalmic use.
Keep out of reach of children.
PRECAUTIONS
General
Systemic absorption of topical corticosteroids has produced
reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations
of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients.
Conditions which augment systemic absorption include the application
of the more potent steroids, 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 or under an occlusive
dressing 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 Use). If irritation
develops, topical corticosteroids should be discontinued and appropriate therapy
instituted.
In the presence of dermatological 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.
Laboratory Tests
The following tests may be helpful in evaluating the hypothalamic-pituitary-adrenal
(HPA) axis suppression: Urinary free cortisol test and ACTH stimulation test.
Carcinogenesis, Mutagenesis, and Impairment of Fertility
Long-term animal studies have not been performed to evaluate
the carcinogenic potential or the effect on fertility of desoximetasone.
Desoximetasone was nonmutagenic in the Ames test.
Pregnancy Category: 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.
Desoximetasone has been shown to be teratogenic and embryotoxic
in mice, rats, and rabbits when given by subcutaneous or dermal routes of administration
in doses 3 to 30 times the human dose of Topicort® (desoximetasone)
Emollient Cream 0.25% or 15 to 150 times the human dose of Topicort®
LP (desoximetasone) Emollient Cream 0.05%.
There are no adequate and well-controlled studies in pregnant
women on teratogenic effects from topically applied corticosteroids. Therefore,
TOPICORT Emollient Cream and TOPICORT LP Emollient Cream should be used during
pregnancy only if the potential benefit justifies the potential risk to the
fetus. Drugs of this class should not be used extensively on pregnant patients,
in large amounts, or for prolonged periods of time.
Nursing Mothers
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 administered
to a nursing woman.
Pediatric Use
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 interacranial
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.
Administration of topical corticosteroids to pediatric patients
should be limited to the least amount compatible with an effective therapeutic
regimen. Chronic corticosteroid therapy may interfere with the growth and development
of pediatric patients.
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