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
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 PRECAUTIONS - Pediatric Use).
If irritation develops, LoKara™ Lotion (desonide lotion
0.05%) 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 LoKara™ Lotion (desonide lotion
0.05%) should be discontinued until the infection has been adequately
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, Impairment of Fertility
Long-term animal studies have not been performed to evaluate
the carcinogenic potential or the effect on reproduction with the use of
Teratogenic effects -Pregnancy Category C
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 desonide lotion. It is also not known
whether desonide lotion can cause fetal harm when administered to a pregnant
woman or can affect reproduction capacity. LoKara™ Lotion (desonide lotion
0.05%) should be given to a pregnant woman only if clearly needed.
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 LoKara™
Lotion (desonide lotion 0.05%) is administered to a nursing woman.
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.