KETODERM Cream (2003)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
KETODERM Cream 2%.
Indications and clinical use
KETODERM (ketoconazole) cream 2% may be indicated for the topical treatment of tinea pedis, tinea corporis and tinea cruris caused by Trichophyton rubrum, T. mentagrophytes and Epidermophyton floccosum; ...
Contraindications
KETODERM (ketoconazole) cream 2% is contraindicated in persons who have shown hypersensitivity to the active or excipient ingredients of this formulation.
Warnings and precautions
Warnings KETODERM (ketoconazole) cream 2% should never be employed for the treatment of infections of the eye. To prevent a rebound effect after stopping a prolonged treatment with topical corticosteroids, ...
Adverse reactions
Short-term studies indicate that Ketoconazole Cream 2% is well tolerated by the skin. During clinical trials, 43 (5.0%) of 867 patients treated with the cream and 3 (1.8%) of 167 patients treated with ...
Dosage and administration
When clinically warranted, therapy with KETODERM (ketoconazole) cream 2% may be initiated while results of culture and susceptibility tests are pending. Treatment should be adjusted according to the findings. ...
Overdosage
There has been no experience with overdosage of Ketoconazole Cream 2%. Treatment should include general supportive measures.
Action and clinical pharmacology
In vitro studies suggest that the antifungal properties of Ketoconazole may be related to its ability to impair the synthesis of ergosterol, a component of fungal and yeast cell membranes. Without the ...
Storage and stability
Store at room temperature, between 15° and 25°C. Keep from freezing.
Dosage forms, composition and packaging
KETODERM cream 2% is a white odourless cream containing 20 mg ketoconazole per gram and is supplied in 30 g tubes.
Pharmaceutical information
Drug Substance Proper Name: ketoconazole Chemical Name:cis-1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)- 2-(1H- imidazol-1-ylmethyl)-1,3-dioxolan-4-yl] methoxy] phenyl] piperazine Structural Formula: Molecular ...
Detailed pharmacology
The systemic absorption of Ketoconazole cream 2% was not measurable in Beagle dogs. When applied to both intact and abraded skin at a daily dose of 80 mg for 28 days, the cream produced plasma levels of ...
Clinical trials
Mycology In Vitro In yeast and fungal cells, ergosterol is the main sterol regulating membrane permeability. Ketoconazole inhibits the biosynthesis of ergosterol and affects the synthesis of triglycerides ...
Toxicology
Animal Studies Subacute Dermal Toxicity in New Zealand White Rabbits and Albino Guinea Pigs Ketoconazole cream 2% at doses of 0, 0.5, 1.0 and 2.0 g/kg was devoid of any irritating effect in 16 male and ...
Marketing authorization holder
TaroPharma Preparation, A Division of Taro Pharmaceuticals Inc., 130 East Drive, Brampton, Ontario, L6T 1C1
Submission control number
086234
Date of approval
Sept 02, 2003
Date of revision
August 6, 2003
References
Borgers M, Van den Bossche H and De Brabander M.: The Mechanism of Action o f the New Antimycotic Ketoconazole. American Journal of Medicine. 74: 2-8, January 1983. Levine HB.: Introduction to Antifungal ...
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