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
Tridesilon Warnings, Precautions, Pregnancy, Nursing, Abuse - Desonide
Tridesilon Warnings, Precautions, Pregnancy, Nursing, Abuse - Desonide
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 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 superpotent 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 axis suppression. 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 Pediatric Use below).
If irritation develops,
DesOwen Cream, Ointment or Lotion 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 DesOwen
(desonide cream, ointment
and lotion) Cream, Ointment or Lotion should be discontinued until
the infection has
been adequately controlled.
Information for patients
Patients using topical
corticosteroids should receive the following information and instructions:
1. This medication
is to be used as directed by the physician. It is for external
use only. Avoid contact
with the eyes.
2. This medication
should not be used for any disorder
other than that for which it was prescribed.
3. The treated skin area
should not be bandaged or otherwise covered or wrapped so as to
be occlusive unless
directed by the physician.
4. Patients should report
to their physician
any signs of local adverse
reactions.
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
Longterm animal studies
have not been performed to evaluate the carcinogenic potential or
the effect on reproduction
with the use of DesOwen Cream, Ointment, and Lotion.
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 in laboratory animals. Animal reproduction
studies have not been conducted with DesOwen Cream, Ointment or
Lotion. It is also not known whether DesOwen Cream, Ointment or
Lotion can cause fetal
harm when administered to a pregnant
woman or can affect
reproduction capacity.
DesOwen Cream, Ointment and Lotion should be given to a pregnant
woman only if clearly
needed.
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 DesOwen Cream, Ointment or Lotion is administered
to a nursing woman.
Pediatric Use
Safety and effectiveness
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 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
absence of response
to ACTH stimulation. Manifestations
of intracranial
hypertension include
bulging fontanelles, headaches, and bilateral
papilledema.
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