No information provided.
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 lotion on the hypothalamic- pituitary-adrenal (HPA) axis, 15 mL were applied without occlusion twice daily (30 mL per day) for 7 days to four adult patients with scalp and body psoriasis. At the end of treatment, the plasma cortisol levels for each of the four patients remained within the normal range and changed little from baseline.
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, ELOCON Lotion (mometasone furoate 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 ELOCON Lotion (mometasone furoate lotion) should be discontinued until the infection has been adequately controlled.
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, Impairment of Fertility: Long-term animal
studies have not been performed to evaluate the carcinogenic potential of ELOCON
(mometasone furoate lotion) Lotion. Long-term carcinogenicity studies of mometasone
furoate were conducted by the inhalation route in rats and mice. In a 2-year
carcinogenicity study in Sprague-Dawley rats, mometasone furoate demonstrated
no statistically significant increase of tumors at inhalation doses up to 67
mcg/kg (approximately 0.04 times the estimated maximum clinical topical dose
from ELOCON Lotion (mometasone furoate lotion) on a mcg/m2 basis). In a 19-month carcinogenicity
study in Swiss CD-1 mice, mometasone furoate demonstrated no statistically significant
increase in the incidence of tumors at inhalation doses up to 160 mcg/kg (approximately
0.05 times the estimated maximum clinical topical dose from ELOCON Lotion on
a mcg/m2 basis).
Mometasone furoate increased chromosomal aberrations in an in vitro
Chinese hamster ovary cell assay, but did increase chromosomal aberrations in
an in vitro Chinese hamster lung cell assay. Mometasone furoate was not
mutagenic in the Ames test or mouse lymphoma assay, and was not clastogenic
in an in vivo mouse micronucleus assay, a rat bone marrow chromosomal aberration assay, or a mouse male germ-cell chromosomal aberration assay. Mometasone
furoate also did not induce unscheduled DNA synthesis in vivo in rat
In reproductive studies in rats, impairment of fertility was not produced in
male or female rats by subcutaneous doses up to 15 mcg/kg (approximately 0.01
times the estimated maximum clinical topical dose from ELOCON Lotion (mometasone furoate lotion) on a mcg/m2
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.
When administered to pregnant rats, rabbits, and mice, mometasone furoate increased fetal malformations. The doses that produced malformations also decreased fetal growth, as measured by lower fetal weights and/or delayed ossification. Mometasone furoate also caused dystocia and related complications when administered to rats during the end of pregnancy.
In mice, mometasone furoate caused cleft palate at subcutaneous doses of 60
mcg/kg and above. Fetal survival was reduced at 180 mcg/kg. No toxicity was
observed at 20 mcg/kg. (Doses of 20, 60 and 180 mcg/kg in the mouse are approximately
0.01, 0.02 and 0.05 times the estimated maximum clinical topical dose from ELOCON
Lotion on a mcg/m2 basis).
In rats, mometasone furoate produced umbilical hernias at topical doses of
600 mcg/kg and above. A dose of 300 mcg/kg produced delays in ossification,
but no malformations. (Doses of 300 and 600 mcg/kg in the rat are approximately
0.2 and 0.4 times the estimated maximum clinical topical dose from ELOCON Lotion
on a mcg/m2 basis).
In rabbits, mometasone furoate caused multiple malformations (e.g., flexed
front paws, gallbladder agenesis, umbilical hernia, hydrocephaly) at topical
doses of 150 mcg/kg and above (approximately 0.2 times the estimated maximum
clinical topical dose from ELOCON Lotion on a mcg/m2 basis). In an
oral study, mometasone furoate increased resorptions and caused cleft palate
and/or head malformations (hydrocephaly and domed head) at 700 mcg/kg. At 2800
mcg/kg most litters were aborted or resorbed. No toxicity was observed at 140
mcg/kg. (Doses of 140, 700 and 2800 mcg/kg in the rabbit are approximately 0.2,
0.9 and 3.6 times the estimated maximum clinical topical dose from ELOCON Lotion (mometasone furoate lotion)
on a mcg/m2 basis).
When rats received subcutaneous doses of mometasone furoate throughout pregnancy
or during the later stages of pregnancy, 15 mcg/kg caused prolonged and difficult labor and reduced the number of live births, birth weight and early pup survival.
Similar effects were not observed at 7.5 mcg/kg. (Doses of 7.5 and 15 mcg/kg
in the rat are approximately 0.005 and 0.01 times the estimated maximum clinical
topical dose from ELOCON Lotion (mometasone furoate lotion) on a mcg/m2 basis).
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.
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 ELOCON Lotion (mometasone furoate lotion) is administered
to a nursing woman.
Pediatric Use: Since safety and efficacy of ELOCON Lotion (mometasone furoate lotion) have not been
established in pediatric patients below 12 years of age, its use in this age
group is not recommended.
ELOCON Lotion (mometasone furoate lotion) caused HPA axis suppression in approximately 29% of pediatric
patients ages 6 to 23 months who showed normal adrenal function by Cortrosyn
test before starting treatment, and were treated for approximately 3 weeks over
a mean body surface area of 40% (range 16% to 90%). The criteria for suppression
were: basal cortisol level of ≤5 mcg/dL, 30-minute post-stimulation level
of ≤18 mcg/dL, or an increase of <7 mcg/dL. Follow-up testing 2 to 4 weeks
after stopping treatment, available for 8 of the patients, demonstrated suppressed
HPA axis function in one patient, using these same criteria. Long-term use of
topical corticosteroids has not been studied in this population. (see CLINICAL
PHARMACOLOGY - Pharmacokinetics).
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 glucocorticosteroid 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 absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.
ELOCON (mometasone furoate lotion) Lotion should not be used in the treatment of diaper dermatitis.
Geriatric Use: Clinical studies of ELOCON Lotion (mometasone furoate lotion) did not include sufficient
number of subjects aged 65 and over to determine whether they respond differently
from younger subjects. Other reported clinical experience has not identified
differences in responses between the elderly and younger patients. In general,
dose selection for an elderly patient should be cautious.