Each gram of cream contains 2.0% w/w Ketoconazole with 0.1% w/w chlorocresol as preservative.
Each mL of shampoo contains 2.0% w/v Ketoconazole.
Excipients/Inactive Ingredients: Potassium sorbate, sodium laureth sulphate, simethicone emulsion, PEG-40 castor oil, D-panthenol, PEG-120 methyl glucose dioleate, hydrochloric acid, pansee bleue parfum RSTT5, ponceau 4R, and purified water.
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 of 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: Treatment and prophylaxis of infections in which the yeast Malassezia (previously called Pityrosporum) is involved, such as Pityriasis versicolor (localized), seborrhoeic dermatitis and Pityriasis capitis (dandruff).
Cream: Apply once daily.
Duration of treatment: Pityriasis versicolor, yeast infection, tinea cruris, Tinea corporis 2 weeks and Tinea pedis 4-6 weeks.
Shampoo: Wash hair and scalp or skin thoroughly with Dezor Shampoo for 3-5 minutes, then rinse clean.
Treatment: Pityriasis versicolor: Once daily for 5 days.
Seborrhoeic dermatitis and Pityriasis capitis: Twice weekly for 2 to 4 weeks.
Maintenance: Pityriasis versicolor: Once daily for 3 days during a single treatment course before exposure to sunshine.
Seborrhoeic dermatitis and Pityriasis capitis: Once every one or two weeks.
No known information available concerning overdosage in human.
Ketoconazole is contraindicated in individuals who have shown hypersensitivity to any of its ingredients.
Cream: Ketoconazole cream is not for ophthalmic use.
Discontinue treatment if irritation or hypersensitivity occurs. Avoid introduction of shampoo into the eyes. Overgrowth of non-susceptible organisms may occur with prolonged use of any topical antimicrobial agent including ketoconazole.
Use in children: Do not use on children under 2 years of age except under the advice and supervision of a doctor.
Cream: Consult doctor if there is no improvement in 4 weeks (for athlete's foot) or 2 weeks (for jock itch).
Animal studies and studies in human volunteers have failed to demonstrate systemic absorption of topically applied Ketoconazole; however due to the teratogenic nature of the active ingredient, Ketoconazole 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.
Keep container well closed. Protect from strong light. Store below 30°C. For external use only.
Recommended shelf-life: 3 years.
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
Dezor shampoo 2%
120 mL x 1's
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