Dermatop Information
Dermatop (Prenicarbate)
Dermatop (Prenicarbate) Description
Dermatop (Prenicarbate) Emollient Cream (prednicarbate emollient cream) 0.1% contains prednicarbate, a synthetic corticosteroid for topical dermatologic use. The chemical name of prednicarbate is 11 17, 21-trihydroxypregna-1,4-diene- 3,20-dione 17-(ethyl carbonate) 21-propionate. Prednicarbate has the empirical formula CHO and a molecular weight of 488.58. Topical corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents.
The CAS Registry Number is 73771-04-7. The chemical structure is:
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 (Prenicarbate) 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 DAB 9.
Dermatop (Prenicarbate) Clinical Pharmacology
Dermatop (Prenicarbate) Indications And Usage
Dermatop (Prenicarbate) Emollient Cream 0.1% is a medium-potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. Dermatop (Prenicarbate) 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 (Prenicarbate) 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.
Dermatop (Prenicarbate) Contraindications
Dermatop (Prenicarbate) Emollient Cream 0.1% is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparations.
Dermatop (Prenicarbate) Precautions
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, A.M. plasma cortisol, and urinary free cortisol tests. Dermatop (Prenicarbate) Emollient Cream 0.1% did not produce significant HPA-axis suppression when used at a dose of 30g/day for a week in 10 adult patients with extensive psoriasis or atopic dermatitis. Dermatop (Prenicarbate) 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
If HPA-axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of the 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.
If irritation develops, Dermatop (Prenicarbate) 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 (Prenicarbate) Emollient Cream 0.1% should be discontinued until the infection has been adequately controlled.
Patients using topical corticosteroids should receive the following information and instructions:
As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within two weeks, contact the physician.
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
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.
Dermatop (Prenicarbate) 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 (Prenicarbate) 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 (Prenicarbate) 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 (Prenicarbate) 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 two patients (2/59, 3%) developed thinness. Three patients (3/59, 5%) were observed with mild telangiectasia. It is unknown whether prior use of topical corticosterioids was a contributing factor in the development of telangiectasia 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 papilledema.
Dermatop (Prenicarbate) Emollient Cream 0.1% should not be used in the treatment of diaper dermatitis.
Dermatop (Prenicarbate) Adverse Reactions
In controlled adult clinical studies, the incidence of adverse reactions probably or possibly associated with the use of Dermatop (Prenicarbate) 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 (Prenicarbate) 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 telangiectasia. It is unknown whether prior use of topical corticosteroids was a contributing factor in the development of telangiectasia in 2 of the patients
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.
Dermatop (Prenicarbate) Overdosage
Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects.
Dermatop (Prenicarbate) Dosage And Administration
Apply a thin film of Dermatop (Prenicarbate) Emollient Cream (prednicarbate emollient cream) 0.1% to the affected skin areas twice daily. Rub in gently.
Dermatop (Prenicarbate) Emollient Cream (prednicarbate emollient cream) 0.1 % may be used in pediatric patients 1 year of age or older. Safety and efficacy of Dermatop (Prenicarbate) 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 (Prenicarbate) Emollient Cream 0.1% should not be used with occlusive dressings unless directed by the physician. Dermatop (Prenicarbate) 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 (Prenicarbate) How Supplied
Dermatop (Prenicarbate) Emollient Cream (prednicarbate emollient cream) 0.1% is supplied in 60 g (NDC 0066-0507-60) tubes.
Dermatop (Prenicarbate)
Dermatop (Prenicarbate) Principal Display Panel - G Tube Carton
NDC 0066-0507-60
FOR DERMATOLOGIC USE ONLY — NOT FOR USE IN EYES
