DERMATOP Emollient Creamc
(prednicarbate emollient cream) 0.1%
FOR DERMATOLOGIC USE ONLY.
NOT FOR USE IN EYES.
DERMATOP Emollient Cream (prednicarbate emollient cream) 0.1% contains prednicarbate,
a synthetic corticosteroid for topical dermatologic use. The chemical name of
prednicarbate is 11(beta), 17, 21-trihydroxypregna-1,4-diene-3,20-dione 17-(ethyl
carbonate) 21-propionate. Prednicarbate has the empirical formula C 27
H 36 O 8 and a molecular weight of 488.58. Topical
corticosteroids constitute a class of primarily synthetic steroids used topically
as anti-inflammatory and antipruritic agents.
Prednicarbate is a practically odorless white to yellow-white powder insoluble
to practically insoluble in water and freely soluble in ethanol.
Each gram of DERMATOP Emollient Cream 0.1% contains 1.0 mg of prednicarbate
in a base consisting of white petrolatum USP, purified water USP, isopropyl
myristate NF, lanolin alcohols NF, mineral oil USP, cetostearyl alcohol NF,
aluminum stearate, edetate disodium USP, lactic acid USP, and magnesium stearate
INDICATIONS AND USES
DERMATOP Emollient Cream 0.1% is a medium-potency corticosteroid indicated
for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive
dermatoses. DERMATOP Emollient Cream 0.1% may be used with caution in pediatric
patients 1 year of age or older. The safety and efficacy of drug use for longer
than 3 weeks in this population have not been established. Since safety and
efficacy of DERMATOP Emollient Cream 0.1% have not been established in pediatric
patients below 1 year of age, its use in this age group is not recommended.
DOSAGE AND ADMINISTRATION
Apply a thin film of DERMATOP Emollient Cream (prednicarbate emollient cream)
0.1% to the affected skin areas twice daily. Rub in gently.
DERMATOP Emollient Cream (prednicarbate emollient cream) 0.1% may be used in
pediatric patients 1 year of age or older. Safety and efficacy of DERMATOP Emollient
cream 0.1% in pediatric patients for more than 3 weeks of use have not been
established. Use in pediatric patients under 1 year of age is not recommended.
As with other corticosteroids, therapy should be discontinued when control
is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis
may be necessary.
DERMATOP Emollient Cream 0.1% should not be used with occlusive dressings unless
directed by the physician. DERMATOP Emollient 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.
DERMATOP Emollient Cream (prednicarbate emollient cream) 0.1% is supplied in
15 g (NDC 0066-0507-15) and 60 g (NDC 0066-0507-60) tubes.
Store between 41 and 77F (5 and 25C).
Prescribing Information as of May 2003
U.S. Patent 4,242,334
A Division of Aventis Pharmaceuticals Inc.
Berwyn, PA, 19312 USA
INFORMATION FOR PATIENTS
Aventis Pharma Deutschland GmbH
D-65926 Frankfurt am Main
Patients using topical corticosteroids should receive the following information
- 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, 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 this medication
in the treatment of diaper dermatitis. This medication 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.
- As with other corticosteroids, therapy should be discontinued when control
is achieved. If no improvement is seen within two weeks, contact the physician.
In common with other topical corticosteroids, prednicarbate has anti-inflammatory,
antipruritic, and vasoconstrictive properties. In general, the mechanism of
the anti-inflammatory activity of topical steroids 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
The extent of percutaneous absorption of topical corticosteroids is determined
by many factors, including the vehicle and the integrity of the epidermal barrier.
Use of occlusive dressings with hydrocortisone for up to 24 hours have not been
shown to increase penetration; however, occlusion of hydrocortisone for 96 hours
does markedly enhance penetration. Topical corticosteroids can be absorbed from
normal intact skin. Inflammation and/or other disease processes in the skin
increase percutaneous absorption.
Studies performed with DERMATOP Emollient Cream (prednicarbate emollient cream)
0.1% indicate that the drug product is in the medium range of potency compared
with other topical corticosteroids.
In controlled adult clinical studies, the incidence of adverse reactions probably
or possibly associated with the use of DERMATOP Emollient Cream 0.1% was approximately
4%. Reported reactions included mild signs of skin atrophy in 1% of treated
patients, as well as the following reactions which were reported in less than
1% of patients: pruritis, edema, paresthesia, urticaria, burning, allergic contact
dermatitis and rash.
In an uncontrolled study in pediatric patients with atopic dermatitis, the
incidence of adverse reactions possibly or probably associated with the use
of DERMATOP Emollient Cream 0.1% was limited. Mild signs of atrophy developed
in 5 patients (5/59, 8%) during the clinical trial, with 2 patients exhibiting
more than one sign. Two patients (2/59, 3%) developed shininess, and 2 patients
(2/59, 3%) developed thinness. Three patients (3/59, 5%) were observed with
mild telangectasia. It is unknown whether prior use of topical corticosteroids
was a contributing factor in the development of telangectasia in 2 of the patients
(See PRECAUTIONS, Pediatric Use.)
The following additional local adverse reactions have been reported infrequently
with topical corticosteroids, but may occur more frequently with the use of
occlusive dressings. These reactions are listed in an approximate decreasing
order of occurrence: folliculitis, acneiform eruptions, hypopigmentation, perioral
dermatitis, secondary infection, striae and miliaria.
No Information Provided.
No Information Provided.
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 under occlusion
should be evaluated periodically for evidence of HPA-axis suppression. This
may be done by using the ACTH stimulation, AM plasma cortisol, and urinary free
DERMATOP Emollient Cream 0.1% did not produce significant HPA-axis suppression
when used at a dose of 30 g/day for a week in 10 adult patients with extensive
psoriasis or atopic dermatitis. DERMATOP Emollient Cream 0.1% did not produce
HPA-axis suppression in any of 59 pediatric patients with extensive atopic dermatitis
when applied BID for 3 weeks to >20% of the body surface (See PRECAUTIONS
, Pediatric Use.)
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
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, DERMATOP Emollient 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 observed 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 DERMATOP Emollient Cream 0.1% should be discontinued until
the infection has been adequately controlled.
The following tests may be helpful in evaluating patients for HPA-axis suppression:
ACTH stimulation test
AM plasma cortisol test
Urinary free cortisol test
Carcinogenesis, Mutagenesis, and Impairment of Fertility
In a study of the effect of prednicarbate on fertility, pregnancy, and postnatal
development in rats, no effect was noted on the fertility or pregnancy of the
parent animals or postnatal development of the offspring after administration
of up to 0.80 mg/kg of prednicarbate subcutaneously.
Prednicarbate has been evaluated in the Salmonella reversion test (Ames test)
over a wide range of concentrations in the presence and absence of an S-9 liver
microsomal fraction, and did not demonstrate mutagenic activity. Similarly,
prednicarbate did not produce any significant changes in the numbers of micronuclei
seen in erythrocytes when mice were given doses ranging from 1 to 160 mg/kg
of the drug.
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.
Prednicarbate has been shown to be teratogenic and embryotoxic in Wistar rats
and Himalayan rabbits when given subcutaneously during gestation at doses 1900
times and 45 times the recommended topical human dose, assuming a percutaneous
absorption of approximately 3%.
In the rats, slightly retarded fetal development and an incidence of thickened
and wavy ribs higher than the spontaneous rate were noted.
In rabbits, increased liver weights and slight increase in the fetal intrauterine
death rate were observed. The fetuses that were delivered exhibited reduced
placental weight, increased frequency of cleft palate, ossification disorders
in the sternum, omphalocele, and anomalous posture of the forelimbs.
There are no adequate and well-controlled studies in pregnant women on teratogenic
effects of prednicarbate. DERMATOP Emollient Cream (prednicarbate emollient
cream) 0.1% 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 excreted in human milk, caution should
be exercised when DERMATOP Emollient Cream 0.1% is administered to a nursing
DERMATOP Emollient Cream 0.1% may be used with caution in pediatric patients
1 year of age or older, although the safety and efficacy of drug use longer
than 3 weeks have not been established. The use of DERMATOP Emollient Cream
(prednicarbate emollient cream) 0.1% is supported by results of a three-week,
uncontrolled study in 59 pediatric patients between the ages of 4 months and
12 years of age with atopic dermatitis. None of the 59 pediatric patients showed
evidence of HPA-axis suppression. Safety and efficacy of DERMATOP Emollient
Cream 0.1% in pediatric patients below 1 year of age have not been established,
therefore 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. In an uncontrolled
study in pediatric patients with atopic dermatitis, the incidence of adverse
reactions possibly or probably associated with the use of DERMATOP Emollient
Cream 0.1% was limited. Mild signs of atrophy developed in 5 patients (5/59,
8%) during the clinical trial, with 2 patients exhibiting more than one sign.
Two patients (2/59, 3%) developed shininess, and 2 patients (2/59, 3%) developed
thinness. Three patients (3/59, 5%) were observed with mild telangectasia. It
is unknown whether prior use of topical corticosteroids was a contributing factor
in the development of telangectasia in 2 of the patients. Adverse effects including
striae have also been reported with inappropriate use of topical corticosteroids
in infants and children. Pediatric patients applying topical corticosteroids
to greater than 20% of body surface are at higher risk for HPA-axis suppression.
HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed
weight gain and intracranial hypertension have been reported in children 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
DERMATOP Emollient Cream 0.1% should not be used in the treatment of diaper
Topically applied corticosteroids can be absorbed in sufficient amounts to
produce systemic effects. (See PRECAUTIONS.)
DERMATOP Emollient Cream 0.1% is contraindicated in those patients with a history
of hypersensitivity to any of the components in the preparations.