Dermatop (Prednicarbate) is a corticosteroid used to reduce the itching, redness, and swelling associated with many skin conditions. DERMATOP® Emollient Cream (prednicarbate emollient cream) 0.1% contains prednicarbate, a synthetic corticosteroid for topical dermatologic use.
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. The use of
DERMATOP Emollient Cream (prednicarbate emollient cream) 0.1% is supported by results of a threeweek,
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.
CHECK WITH YOUR DOCTOR AS SOON AS POSSIBLE if you experience itching, burning, redness, or swelling. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist.