Source: Health Products and Food Branch (CA) Revision Year: 2022
DERMATOP (prednicarbate ointment/emollient cream, 0.1%) is indicated for the relief of the inflammatory and pruritic manifestations of acute and chronic corticosteroid-responsive dermatoses. The emollient cream formulation has been shown to be safe and effective in infants and children.
Apply a thin film of DERMATOP (prednicarbate ointment/emollient cream, 0.1%) to affected areas of skin twice daily. Rub in gently and completely.
Therapy should be limited to two weeks. If a symptomatic response is not noted within a few days to a week, the local applications of corticosteroid should be discontinued, and the patient reevaluated. Therapy should be discontinued as soon as lesions heal. DERMATOP should not be used with occlusive dressings unless directed by the physician.
DERMATOP EMOLLIENT CREAM 0.1% may be used with caution in pediatric patients 1 year of age or older. 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.
No specific antidote to prednicarbate is available and treatment should be symptomatic. Topically applied DERMATOP (prednicarbate ointment/emollient cream, 0.1%) can be absorbed systemically. Percutaneous absorption is enhanced when large amounts of corticosteroids are applied, when used under occlusive dressing or when used chronically. Toxic effects of hypercorticism and adrenal suppression may appear. Should toxic effects occur, the dosage of DERMATOP should be discontinued slowly, consistent with accepted procedures for discontinuation of chronic steroid therapy. The restoration of hypothalamic-pituitary axis may be slow; and during periods of pronounced physical stress (severe infections, trauma, surgery); a supplement with systemic steroids may need to be considered. Toxic effects may include ecchymosis of skin, peptic ulceration, hypertension, aggravation of infection, hirsutism, acne, edema and muscle weakness due to protein depletion. Treatment of a patient with systemic toxic manifestations consists of assuring and maintaining a patent airway and supporting ventilation using oxygen and assisted or controlled respiration as required. This usually will be sufficient in the management of most reactions. Should circulatory depression occur, vasopressors such as ephedrine and i.v. fluids may be used. Should a convulsion persist despite oxygen therapy, small increments of an ultra-short acting barbiturate (pentobarbital or secobarbital) may be given i.v. Allergic reactions are characterized by cutaneous lesions, urticaria, edema or anaphylactoid reactions.
For management of a suspected drug overdose, contact your regional Poison Control Centre.
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