Cream: A white cream containing 2.0% w/w Ketoconazole with 0.1% w/w chlorocresol as preservative.
Shampoo: A red viscous liquid with characteristic odour.
Pharmacology: Pharmacodynamics: Ketoconazole is an imidazole antifungal agent which interferes with ergosterol synthesis and therefore alters the permeability of the cell membrane of sensitive fungi.
Pharmacokinetics: Ketoconazole is a broad-spectrum synthetic antifungal agent which inhibits the growth of the following common dermatophytes and yeasts by altering the permeability of the cell membrane: Dermatophytes-Trichophyton rubrum, T. mentagrophytes, T. tonsurans, Microsporum canis, M. audouini, M. gypseum and Epidermophyton floccosum; Yeasts-Candida albicans and C. tropicalis and the organism responsible for tinea versicolor, Malassezia furfur (Pityrosporum orbiculare).
Cream: Development of resistance to Ketoconazole has not been established. In vitro studies suggest that Ketoconazole impairs the synthesis for ergosterol which is a vital component of fungal cell membranes. The mechanism of therapeutic effect of Ketoconazole in seborrhoeic dermatitis has not been established.
Shampoo: Ketoconazole 2.0% shampoo may be effective in seborrhoeic dermatitis where yeast Pityrosporum is involved. A double-blind study in 50 patients with seborrhoeic dermatitis has shown Ketoconazole 2% cream/shampoo to be as effective as hydrocortisone 1% cream in providing symptomic improvement and to be more effective in reducing the number of yeast cells.
Cream: Topical treatment of tinea corporis, tinea cruris, tinea pedis, pityriasis versicolor and cutaneous candidiasis.
Shampoo: Prevention and treatment of infections in which the yeast Malassezia (previously called Pityrosporum) is likely to be involved, such as dandruff, seborrhoeic dermatitis and tinea (Pityriasis) versicolor.
Cream: Apply once daily.
Duration of treatment: Pityriasis versicolor, yeast infection, tinea cruris, tinea corporis 2 weeks and tinea pedis 4-6 weeks.
Shampoo: For topical administration.
Dezor Shampoo is for use in adolescents and adults.
Direction of use: Wash affected thoroughly with Dezor Shampoo and leave for 3-5 minutes before rinsing.
Treatment: Seborrhoeic dermatitis and dandruff: Wash hair twice weekly for 2 to 4 weeks.
Tinea versicolor: once daily for maximum 5 days.
Prophylaxis: Seborrhoeic dermatitis and dandruff: once every 1 to 2 weeks.
Tinea versicolor: once daily for maximum 3 days before exposure to sunshine.
No known information available concerning overdosage in human.
Ketoconazole is contraindicated in individuals who have shown hypersensitivity to any of its ingredients.
Ketoconazole cream is not for ophthalmic use.
If irritation or sensitivity occurs, treatment should be discontinued. Do not use on children under 2 years of age except under the advice and supervision of a doctor. Avoid contact with eyes and mucous membranes (for external use only). Overgrowth of non-susceptible organisms may occur with prolonged use of any topical antimicrobial agent including Ketoconazole.
Cream: Consult doctor if there is no improvement in 4 weeks (for athlete's foot) or 2 weeks (for jock itch).
Use in pregnancy and lactation: Animal studies and studies in human volunteers have failed to demonstrate systemic absorption of topically applied Ketoconazole cream and Ketoconazole shampoo; however due to the teratogenic nature of the active ingredient, Ketoconazole cream and shampoo should only be used in pregnant or lactating woman if in the judgement of the treating physician, the expected benefits outweigh the potential risk.
Animal studies and studies in human volunteers have failed to demonstrate systemic absorption of topically applied Ketoconazole cream and Ketoconazole shampoo; however due to the teratogenic nature of the active ingredient, Ketoconazole cream and shampoo should only be used in pregnant or lactating woman if in the judgement of the treating physician, the expected benefits outweigh the potential risk.
Signs of skin irritation, burning sensation, pruritus, dermatitis were observed in 3% of Ketoconazole treated patients and in 2% of placebo controls during clinical trials.
Concomitant administration of Ketoconazole with rifampicin results in decreased antifungal activity. Concurrent use of Ketoconazole and Phenytoin may alter serum concentrations of both drugs.
Store below 30°C. For external use only.
Recommended shelf-life: 3 years.
Shampoo: Keep container well closed. Protect from strong light.
D01AC08 - ketoconazole ; Belongs to the class of imidazole and triazole derivatives. Used in the topical treatment of fungal infection.
Dezor cream 2%
15 g x 1's;450 g x 1's
Dezor shampoo 2%
120 mL x 1's
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