Document
DailyMed Label: Elocon
Title
DailyMed Label: Elocon
Date
2010
Document type
DailyMed Prescription
Name
Elocon
Generic name
mometasone furoate
Manufacturer
Physicians Total Care, Inc.
Product information
NDC: 54868-2223
Product information
NDC: 54868-2223
Description
ELOCON ® (mometasone furoate cream) Cream
0.1% contains mometasone furoate, USP for dermatologic use. Mometasone furoate
is a synthetic corticosteroid with anti-inflammatory activity.
Chemically, mometasone furoate is
9α,21-Dichloro-11β,17-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione
17-(2-furoate), with the empirical formula C 27 H 30 Cl 2 O 6 , a
molecular weight of 521.4 and the following structural formula:
Mometasone furoate is a white to off-white powder practically insoluble in
water, slightly soluble in octanol, and moderately soluble in ethyl alcohol.
Each gram of ELOCON Cream 0.1% contains: 1 mg mometasone furoate, USP in a
cream base of hexylene glycol, phosphoric acid, propylene glycol stearate (55%
monoester), stearyl alcohol and ceteareth-20, titanium dioxide, aluminum starch
octenylsuccinate (Gamma Irradiated), white wax, white petrolatum, and purified
water.
image of chemical structure
Indications
ELOCON Cream 0.1% is a medium potency corticosteroid indicated
for the relief of the inflammatory and pruritic manifestations of
corticosteroid-responsive dermatoses.
ELOCON (mometasone furoate cream) Cream 0.1% may be used 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 (see
PRECAUTIONS – Pediatric Use
section). Since
safety and efficacy of ELOCON Cream 0.1% have not been established in pediatric
patients below 2 years of age, its use in this age group is not recommended.
Dosage
Apply a thin film of ELOCON Cream 0.1% to the affected skin areas
once daily. ELOCON Cream 0.1% may be used in pediatric patients 2 years of age
or older. Since safety and efficacy of ELOCON Cream 0.1% have not been
adequately established in pediatric patients below 2 years of age, its use in
this age group is not recommended (see
PRECAUTIONS – Pediatric Use
section).
As with other corticosteroids, therapy should be discontinued when control is
achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis
may be necessary. Safety and efficacy of ELOCON Cream 0.1% in pediatric patients
for more than 3 weeks of use have not been established.
ELOCON Cream 0.1% should not be used with occlusive dressings unless directed
by a physician. ELOCON Cream 0.1% should not be applied in the diaper area if
the child still requires diapers or plastic pants as these garments may
constitute occlusive dressing.
Contraindications
ELOCON Cream 0.1% is contraindicated in those patients with a history of
hypersensitivity to any of the components in the preparation.
Precautions
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 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.
In a study evaluating the effects of mometasone furoate cream 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 was
applied without occlusion to at least 30% of the body surface. The results show
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, ELOCON Cream 0.1% 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 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 Cream 0.1% 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.
This medication should not be used for any disorder other than that for
which it was prescribed.
The treated skin area should not be bandaged or otherwise covered or wrapped
so as to be occlusive, unless directed by the physician.
Patients should report to their physician any signs of local adverse
reactions.
Parents of pediatric patients should be advised not to use ELOCON Cream 0.1%
in the treatment of diaper dermatitis. ELOCON Cream 0.1% should not be applied
in the diaper area as diapers or plastic pants may constitute occlusive dressing
(see
DOSAGE AND
ADMINISTRATION
).
This medication should not be used on the face, underarms, or groin areas
unless directed by the physician.
As with other corticosteroids, therapy should be discontinued when control
is achieved. If no improvement is seen within 2 weeks, contact the
physician.
Other corticosteroid-containing products should not be used with ELOCON
Cream 0.1% without first consulting with the physician.
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 cream) Cream 0.1%.
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 Cream 0.1% on a mcg/m 2 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 Cream 0.1% on a mcg/m 2
basis).
Mometasone furoate increased chromosomal aberrations in an in vitro Chinese hamster ovary cell assay, but did not
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 hepatocytes.
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 Cream 0.1% on a
mcg/m 2 basis).
Pregnancy
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 Cream 0.1% on a mcg/m 2 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 Cream 0.1%
on a mcg/m 2 basis.)
In rabbits, mometasone furoate caused multiple malformations (eg, 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 Cream 0.1% on a mcg/m 2
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 at 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 Cream 0.1% on a mcg/m 2 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 Cream 0.1% on a mcg/m 2 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 Cream 0.1% is administered to a
nursing woman.
Pediatric Use ELOCON Cream 0.1% 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 ELOCON Cream 0.1% is supported by
results from adequate and well-controlled studies in pediatric patients with
corticosteroid-responsive dermatoses. Since safety and efficacy of ELOCON Cream
0.1% have not been established in pediatric patients below 2 years of age, its
use in this age group is not recommended.
ELOCON Cream 0.1% caused HPA axis suppression in approximately 16% 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 41% (range 15% to 94%). The criteria for
suppression were: basal cortisol level of less than or equal to 5 mcg/dL, 30-minute post-stimulation
level of less than or equal to 18 mcg/dL, or an increase of less than 7 mcg/dL. Follow-up testing 2 to 4
weeks after study completion, available for 5 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
section).
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.
ELOCON (mometasone furoate cream) Cream 0.1% should not be used in the
treatment of diaper dermatitis.
Geriatric Use Clinical studies of ELOCON Cream 0.1% included 190 subjects who
were 65 years of age and over and 39 subjects who were 75 years of age and over.
No overall differences in safety or effectiveness were observed between these
subjects and younger subjects, and other reported clinical experience has not
identified differences in responses between the elderly and younger patients.
However, greater sensitivity of some older individuals cannot be ruled out.
How supplied
ELOCON Cream 0.1% is supplied in:
15-g (NDC 54868-2223-0) tubes; boxes of one.
45-g
(NDC 54868-2223-1) tubes; boxes of one.
Store at 25°C (77°F); excursions permitted to 15–30°C
(59–86°F) [see USP Controlled Room Temperature]
Schering Corporation Kenilworth, NJ 07033 USA
Rev. 3/04
18724340T
B-28070500 Copyright © 1987, 2003, Schering Corporation. All rights
reserved.
Relabeling of "Additional" barcode label by:
Physicians Total Care, Inc. Tulsa, OK 74146
Clinical pharmacology
Like other topical corticosteroids, mometasone furoate has
anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism
of the anti-inflammatory activity of the topical steroids, in general, is
unclear. However, corticosteroids are thought to act by the induction of
phospholipase A 2 inhibitory proteins, collectively called
lipocortins. It is postulated that these proteins control the biosynthesis of
potent mediators of inflammation such as prostaglandins and leukotrienes by
inhibiting the release of their common precursor arachidonic acid. Arachidonic
acid is released from membrane phospholipids by phospholipase A 2 .
Pharmacokinetics The extent of percutaneous absorption of topical corticosteroids
is determined by many factors including the vehicle and the integrity of the
epidermal barrier. Occlusive dressings with hydrocortisone for up to 24 hours
have not been demonstrated to increase penetration; however, occlusion of
hydrocortisone for 96 hours markedly enhances penetration. Studies in humans
indicate that approximately 0.4% of the applied dose of ELOCON Cream 0.1% enters
the circulation after 8 hours of contact on normal skin without occlusion.
Inflammation and/or other disease processes in the skin may increase
percutaneous absorption.
Studies performed with ELOCON Cream 0.1% indicate that it is in the medium
range of potency as compared with other topical corticosteroids.
In a study evaluating the effects of mometasone furoate cream 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 was
applied without occlusion to at least 30% of the body surface. The results show
that the drug caused a slight lowering of adrenal corticosteroid secretion.
In a pediatric trial, 24 atopic dermatitis patients, of which 19 patients
were age 2 to 12 years, were treated with ELOCON Cream 0.1% once daily. The
majority of patients cleared within 3 weeks.
Ninety-seven pediatric patients ages 6 to 23 months, with atopic dermatitis,
were enrolled in an open-label, hypothalamic-pituitary-adrenal (HPA) axis safety
study. ELOCON Cream 0.1% was applied once daily for approximately 3 weeks over a
mean body surface area of 41% (range 15% to 94%). In approximately 16% of
patients who showed normal adrenal function by Cortrosyn test before starting
treatment, adrenal suppression was observed at the end of treatment with ELOCON
Cream 0.1%. The criteria for suppression were: basal cortisol level of less than or equal to 5
mcg/dL, 30-minute post-stimulation level of less than or equal to 18 mcg/dL, or an increase of less than 7
mcg/dL. Follow-up testing 2 to 4 weeks after stopping treatment, available for 5
of the patients, demonstrated suppressed HPA axis function in one patient, using
these same criteria.
Package label
ELOCON Cream 0.1%
image of package label
1 organization
2 products
Organization
Physicians Total Care, Inc.