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
Maxiflor Warnings, Precautions, Pregnancy, Nursing, Abuse - Diflorasone
Maxiflor Warnings, Precautions, Pregnancy, Nursing, Abuse - Diflorasone
WARNINGS
No information provided.
PRECAUTIONS
General
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 receiving a large dose
of a higher potency
topical steroid applied
to a large surface area
or under an occlusive
dressing 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.
This product has a
greater ability to produce
adrenal suppression
than does Psorcon® (diflorasone diacetate) Ointment 0.05%. At
30 g per day (applied as
15 g twice daily) Psorcon® Cream 0.05% was shown to cause inhibition
of the HPA axis in one
of two patients following application for one week to psoriatic
skin. At 15 g per
day (applied as 7.5 g twice daily) Psorcon® Cream was shown
to cause mild inhibition
of the HPA axis in one of five patients following application for
one week to diseased skin (psoriasis or atopic
dermatitis). These effects were reversible
upon discontinuation of treatment. By comparison, Psorcon® (diflorasone
diacetate) Ointment 0.05% did not produce significant
HPA axis suppression when
used in divided doses at 30 g per
day for one week in patients with psoriasis or atopic
dermatitis.
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 and complete 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 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,
Psorcon® (diflorasone diacetate
cream) 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 antibacterial
agent should be used.
If a favorable response does not occur promptly, use of Psorcon®
(diflorasone diacetate
cream) should be discontinued until the infection
has been adequately controlled.
Psorcon® (diflorasone diacetate
cream) should not be used in the treatment of rosacea
or perioral dermatitis,
and it should not be used on the face, groin, or axillae.
Information for Patients
See PATIENT INFORMATION
section.
Laboratory Tests
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 diflorasone diacetate.
Diflorasone diacetate
was not found to be mutagenic in a micronucleus test in rats at
dosages of 2400 mg/kg.
Studies in the rat following
topical administration
at doses up to 0.5 mg/kg revealed no
effects on fertility.
Pregnancy
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 to laboratory
animals.
Diflorasone diacetate
has been shown to be teratogenic
(cleft palate) in rats when applied topically at a dose
of approximately 0.001 mg/kg/day to the shaven thorax
of pregnant animals.
This is approximately 0.3 times the human
topical dose
of Psorcon® (diflorasone diacetate
cream). When pregnant rats were treated topically with approximately
0.5 mg/kg/day, uterine deaths were higher in the treated animals
than in control animals.
In rabbits, cleft palate
was seen when diflorasone diacetate
was applied in topical
doses as low as 20 mg/kg/day. In
addition, fetal weight
was depressed and litter
sizes were smaller.
There are no adequate and
well-controlled studies of the teratogenic potential of diflorasone
diacetate in pregnant
women. Psorcon® Cream should be used during pregnancy
only if the potential
benefit justifies the
potential risk
to the fetus.
Nursing Mothers
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 Psorcon® (diflorasone
diacetate cream) is administered to a nursing
woman.
Pediatric Use
Safety and effectiveness
of Psorcon® (diflorasone diacetate
cream) in pediatric
patients have not been established. 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
when they are treated with topical
corticosteroids. They are, therefore, also at greater risk
of glucocorticosteroid insufficiency
after withdrawal
of treatment and of Cushing's syndrome
while on treatment. Adverse effects including striae have been reported
with inappropriate use of topical
corticosteroids in pediatric
patients.
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.
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