No information provided.
Systemic absorption of topical corticosteroids can
produce reversible hypothalamic-pituitaryadrenal (HPA) axis suppression with
the potential for glucocorticoid 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 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. Infrequently, signs and symptoms of
glucocorticoid 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, Capex® Shampoo should be
discontinued and appropriate therapy instituted.
Allergic contact dermatitis with corticosteroids is
usually diagnosed by a 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
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 Capex® Shampoo should be discontinued
until the infection has been adequately controlled.
Information For Patients
Patients using topical corticosteroids should receive the
following information and instructions:
- This medication is to be used as directed by the
physician. It is for external use only. Avoid contact with the eyes. In case of
contact, wash eyes liberally with water.
- This medication should not be used for any disorder other
than that for which it was prescribed.
- The treated scalp area should not be bandaged or
otherwise covered or wrapped so as to be occlusive unless directed by the
- Patients should report to their physician any signs of
local adverse reactions.
- Discard contents after two (2) months.
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 or the effect on fertility of Capex®
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.
There are no adequate and well-controlled studies in pregnant
women or teratogenic effects from Capex® Shampoo. Therefore, Capex® Shampoo
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 secreted in human milk, caution should be exercised when Capex® Shampoo is
administered to a nursing woman.
Safety and effectiveness in children and infants 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
a greater risk of glucocorticoid 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
HPA axis suppression, Cushing's syndrome and intracranial
hypertension have been reported in children receiving topical corticosteroids.
Manifestations of adrenal suppression in children 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.