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
Elocon Warnings, Precautions, Pregnancy, Nursing, Abuse - Mometasone Furoate
Elocon Warnings, Precautions, Pregnancy, Nursing, Abuse - Mometasone Furoate
WARNINGS
No information provided.
PRECAUTIONS
Cream and Ointment
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 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.
In a study evaluating the effects of mometasone furoate cream
and ointment on the hypothalamic-pituitary-adrenal (HPA) axis, 15
grams were applied twice daily for 7 days to six adult
patients with psoriasis
or atopic dermatitis.
The cream and ointment
were each applied without occlusion
to at least 30% of the body surface. The results wshow
that the drug caused a
slight lowering of adrenal
corticosteroid
secretion.
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 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,
mometasone furoate cream
and ointment 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 mometasone
furoate cream and ointment
should be discontinued until the infection
has been adequately controlled.
Lotion
General: Systemic absorption
of potent topical
corticosteroids has produced reversible
hypothalamic-pituitary-adrenal (HPA) axis
suppression, manifestations of Cushing's syndrome, hyperglycemia,
and glucosuria in
some patients.
Conditions which augment systemic
absorption include
application of more potent
steroids, use over large surface
areas, prolonged use, use in areas where the epidermal barrier
is disrupted, and the use of occlusive dressings. (See DOSAGE
AND ADMINISTRATION).
Patients receiving a large dose
of a potent topical
steroid applied to a
large surface area
or under an occlusive
dressing should be
evaluated periodically for evidence
of HPA axis suppression
by using the urinary free cortisol
and ACTH stimulation
tests. 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 and
complete upon discontinuation of the drug. Infrequently, signs and
symptoms of steroid withdrawal may occur, requiring supplemental
systemic corticosteroids.
Children may absorb
proportionally larger amounts of topical
corticosteroids and thus be more susceptible
to systemic toxicity.
(See PRECAUTIONS
, Pediatric Use.)
If irritation develops,
topical corticosteroids
should be discontinued and appropriate
therapy instituted.
In the presence of dermatological infections, use of an appropriate
antifungal or antibacterial
agent should be instituted.
If a favorable response does not occur promptly, the corticosteroid
should be discontinued until the infection
has been adequately controlled.
Information for the Patient
Patients Using Topical Corticosteroids Should Receive the Following
Information and Instructions:
1. This medication
is to be used by the physician. It is for external use only. Avoid
contact with the eyes.
2. Patients should be advised not to use this medication
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 as to be occlusive
unless directed by the physician. (See DOSAGE
AND ADMINISTRATION.)
4. Patients should report
any signs of local adverse
reactions.
5. Parents of pediatric
patients should be advised not to use tight-fitting diapers or plastic
pants on a child being
treated in the diaper area, as these garments may constitute occlusive
dressing. (See DOSAGE AND ADMINISTRATION.)
6. For cream
and ointment only:
As with other corticosteroids,
therapy should be discontinued when control
is achieved. If no improvement is seen within 2 weeks, contact
the physician.
7. For cream
and ointment only:
This medication should not be used on the face, underarms, or groin
areas unless directed by the physician.
Laboratory Tests
The following Tests May be Helpful in Evaluating HPA Axis Suppression:
1. Urinary free cortisol
test
2. ACTH stimulation
test
3. A.M. plasma
cortisol test
(for cream and ointment
only)
Carcinogenesis, Mutagenesis, and Impairment of Fertility
For all Forms: Long-term animal
studies have not been performed to evaluate the carcinogenic
potential or the effect
on fertility of topical
corticosteroids.
Genetic toxicity studies with mometasone furoate, which included
the Ames test, mouse lymphoma
assay, and a micronucleus
test, did not reveal any mutagenic potential.
For Cream and Ointment: In
studies of the effect
of mometasone furoate on fertility, pregnancy, and postnatal
development in rats
and rabbits, 25 rats were treated with doses up to 1.2 mg/kg of
drug topically, and 15
rabbits with doses up to 0.3 mg/kg of drug
topically. The drugs were left
on the skin for 6 hours
daily during gestation. At
the highest dosage, the rat
dams lost weight. One of the rabbit dams at the highest dosage had
wrinkled skin, muscle
wasting and aborted
5 fetuses.
Pregnancy Category C
Cream and Ointment: 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.
Rat offspring of dams treated with 1.2 mg/kg of mometasone furoate
topically (4 times the maximum
dose in a 50 kg
individual) displayed umbilical
hernias, unossified sternebrae and vertebrae, and wavy ribs, as
well as markedly depressed fetal
growth. Rabbit offspring of dams treated with up to 0.3 mg/kg of
mometasone furoate topically (the same dose
as the maximum dose
in a 50 kg individual) displayed
flexed paws, umbilical
hernias, and cleft palate. A 50 kg
female using 1 gram
of mometasone furoate cream
and ointment would apply approximately 0.023 mg/kg.
There are no adequate and well-controlled studies of the teratogenic
potential of mometasone furoate in pregnant
women. Mometasone furoate cream and ointment
should be used during pregnancy only if the potential
benefit justifies the potential
risk to the fetus.
Lotion: Corticosteroids are generally teratogenic
in laboratory animals when administered systemically at relatively
low dosage levels. Corticosteroids
have been shown to be teratogenic
after dermal application in laboratory animals. There are no adequate
and well-controlled studies of teratogenic
effects from topically applied corticosteroids in pregnant women.
Therefore, topical corticosteroids
should be used during pregnancy only if the potential
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.
Nursing Mothers
Cream and Ointment: 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 mometasone furoate cream
and ointment are administered
to a nursing woman.
Lotion: It is not known whether topical
administration of corticosteroids could result in sufficient systemic
absorption to produce
detectable quantities in breast
milk. Systemically administered corticosteroids are secreted into
breast milk
in quantities not likely to have a deleterious effect on the infant.
Nevertheless, a decision should be made whether to discontinue nursing
or to discontinue the drug, taking into account the importance of
the drug to the mother.
Pediatric Use
Cream and Ointment: Mometasone furoate cream
and ointment may be used with caution in pediatric
patients 2 years of age
or older, although the safety and efficacy of drug
use for longer than 3 weeks have not been established. Use of mometasone
furoate cream and ointment
is supported by results from adequate and well-controlled studies
in pediatric patients
with corticosteroid-responsive dermatoses. Since safety and efficacy
of mometasone furoate cream
and ointment have not
been established in pediatric patients below 2 years of age, its
use in this age group
is not recommended. 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 syndrome
when they are treated with topical
corticosteroids. They are, therefore, also at greater risk
of adrenal insufficiency
during and/or after withdrawal
of treatment. Pediatric patients may be more susceptible than adults
to skin atrophy, including
striae, when they are treated with topical corticosteroids. Pediatric
patients applying topical
corticosteroids to greater than 20% of body surface
are at higher risk of HPA
axis suppression.
HPA axis suppression,
Cushing's syndrome, linear
growth retardation, delayed
weight gain, and intracranial
hypertension have
been reported in pediatric patients receiving topical
corticosteroids. Manifestations 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.
Mometasone furoate cream
and ointment should
not be used in the treatment of diaper dermatitis.
Lotion: Pediatric patients may demonstrate greater
susceptibility to topical
corticosteroid-induced HPA axis
suppression and
Cushing's syndrome
than mature patients
because of a larger skin
surface area to body weight
ratio.
Hypothalamic-pituitary-adrenal (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.
Administration of topical
corticosteroids to children should be limited to the least amount
compatible with an
effective therapeutic
regimen. Chronic corticosteroid therapy may interfere with the growth
and development
of children.
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