DERMATOP Ointment, Cream (2022)

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Name of the medicinal product

DERMATOP OINTMENT Prednicarbate Ointment 0.1% DERMATOP EMOLLIENT CREAM Prednicarbate Emollient Cream 0.1%

Indications and clinical use

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 ...

Contraindications

DERMATOP (prednicarbate ointment/emollient cream, 0.1%) is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. DERMATOP EMOLLIENT CREAM contains ...

Warnings and precautions

Warnings When used under occlusive dressing, over extensive areas, or on the face, scalp, axillae and scrotum, sufficient absorption of the topical corticosteroid may occur, giving rise to adrenal suppression ...

Adverse reactions

In controlled clinical trials in adults, the total incidence of adverse reactions associated with the use of DERMATOP OINTMENT (prednicarbate ointment 0.1%) was low (1.6%). These adverse reactions were ...

Dosage and administration

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 ...

Overdosage

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 ...

Action and clinical pharmacology

DERMATOP (prednicarbate ointment/emollient cream, 0.1%) is a mid-potency, non-fluorinated topical corticosteroid. Topical corticosteroids are synthetic derivatives of cortisone which are effective when ...

Special handling instructions

The active ingredient in DERMATOP (prednicarbate ointment/emollient cream, 0.1%) is prednicarbate. Prednicarbate belongs to a group of medicines called corticosteroids and is of medium strength. In certain ...

Dosage forms, composition and packaging

DERMATOP OINTMENT (prednicarbate ointment, 0.1%) is available in tubes of 60 grams for topical use. DERMATOP EMOLLIENT CREAM (prednicarbate emollient cream, 0.1%) is available in tubes of 20 and 60 grams ...

Pharmaceutical information

Drug Substance Proper Name: Prednicarbate Chemical Name: Pregna-1,4-diene-3,20-dione,17(ethoxy-carbonyl)oxy-11- hydroxy-21-(1-oxopropoxy)-,(11β) Structural Formula: Molecular Formula: C<sub>27</sub>H ...

Detailed pharmacology

In vitro Effect on proliferative capacity of fibroblasts in culture by gluco-corticosteroids was evaluated. Growth inhibition was not observed with prednicarbate or hydrocortisone at a concentration of ...

Clinical trials

Ointment Four multi-centre double blind, randomized trials support the efficacy of DERMATOP OINTMENT (prednicarbate ointment, 0.1%) in the treatment of corticosteroid-responsive dermatoses (psoriasis and ...

Toxicology

Acute Toxicity The acute toxicity of prednicarbate was determined orally in immature mouse and rat, subcutaneously in immature rat and topically in white rabbits. The oral LD<sub>50</sub>'s were 3102 mg/kg ...

Marketing authorization holder

Bausch Health, Canada Inc., 2150 St-Elzear Blvd. West, Laval, Quebec, H7L 4A8

Submission control number

241609

Date of revision

November 27, 2020

References

Alpermann H.G., Sandow J. and Vogel H.G.: Animal experimental studies and systemic activity of prednisolone-17-ethyl carbonate-21-propionate. Z. Hautkr: 61 (Suppl. 1): 7-17, 1985. Barth J. et al: Studies ...