No information provided.
Systemic absorption of topical corticosteroids has caused
reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the
potential for glucocorticos-teroid 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.
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 applying a topical steroid to a large
surface area or to ar-eas under occlusion should be evaluated periodically for
evidence 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 steroid.
Recovery of HPA axis function is generally prompt upon
discontinuation of topical corticosteroids. Infrequently, signs and symptoms of
glucocorticoster-oid 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, Luxiq should be discontinued and
appropriate therapy instituted. Allergic contact dermatitis with
corticosteroids is usually diagnosed by observing a failure to heal rather than
noting a clinical exacerbation, as with most topical products not containing
corticosteroids. Such an observa-tion should be corroborated with appropriate
diagnostic patch testing.
In the presence of dermatological infections, the use of
an appropriate antifun-gal or antibacterial agent should be instituted. If a
favorable response does not occur promptly, use of Luxiq 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 exter-nal use only. Avoid contact with the eyes.
- 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.
- As with other corticosteroids, therapy should be
discontinued when control is achieved. If no improvement is seen within 2
weeks, contact the physician.
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 carcino-genic potential or the effect on fertility of
Betamethasone was genotoxic in the in vitro human
peripheral blood lympho-cyte chromosome aberration assay with metabolic
activation and in the in vivo mouse bone marrow micronucleus assay.
Pregnancy Category C
Corticosteroids have been shown to be teratogenic in
laboratory animals when administered systemically at relatively low dosage
levels. Some corticoster-oids have been shown to be teratogenic after dermal
application in laboratory animals. There are no adequate and well-controlled
studies in pregnant women. Therefore, Luxiq should be used during pregnancy
only if the poten-tial 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.
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
detect-able quantities in breast milk. Because many drugs are excreted in human
milk, caution should be exercised when Luxiq is administered to a nursing
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
and Cushing's syn-drome when they are treated with topical corticosteroids.
They are therefore also at greater risk of adrenal insufficiency during and/or
after withdrawal of treatment. Adverse effects including striae have been
reported with inappro-priate use of topical corticosteroids in infants and
Hypothalamic-pituitary-adrenal (HPA) axis suppression,
Cushing's syndrome, linear growth retardation, delayed weight gain, and
intracranial hypertension have been reported in children receiving topical
corticosteroids. Manifesta-tions of adrenal suppression in children include low
plasma cortisol levels and an absence of response to ACTH stimulation.
Manifestations of intracranial hypertension include bulging fontanelles,
headaches, and bilateral papilledema.
Administration of topical corticosteroids to children
should be limited to the least amount compatible with an effective therapeutic
regimen. Chronic corti-costeroid therapy may interfere with the growth and
development of children.