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Dezor

Dezor is essentially a regional brand. Its marketing authorisation extends to six countries clustered across Southeast Asia and nearby markets, and its active ingredient is ketoconazole. Travellers who have come across Dezor in Bangkok, Jakarta, Kuala Lumpur, or Ho Chi Minh City are unlikely to find the same brand on a pharmacy shelf in Europe, the Americas, or Africa, where ketoconazole circulates under different commercial names.

Ketoconazole is classified as a broad-spectrum antifungal. Dezor is registered for use across a range of fungal skin conditions, including seborrheic dermatitis, athlete's foot, jock itch, cutaneous candidiasis, and vaginal candidiasis, as well as other dermatological infections listed in the structured indication block further down this page. The breadth of the indication list reflects the broad-spectrum positioning of ketoconazole within the antifungal category.

The specific markets where Dezor is registered — Vietnam, Indonesia, Hong Kong, Thailand, Malaysia, and Singapore — share overlapping regulatory traditions and drug-distribution channels, which is why the brand has settled into this regional footprint rather than spreading more widely. Outside this cluster, travellers and expatriates will typically encounter ketoconazole-containing products under entirely different brand names, sometimes as generics, sometimes in slightly different formulations.

Other antifungal molecules are also widely sold internationally, and a local pharmacist is the right person to translate between a Dezor prescription written in one country and the equivalent product available in another. Because antifungal therapy is matched to the organism and the site of infection, any substitution or change in treatment should be made in consultation with a healthcare provider rather than at the pharmacy counter alone.

Countries
Hong Kong Indonesia Malaysia Singapore Thailand Vietnam
Diseases
Dermatitis Infection Jock Itch Seborrheic Dermatitis Candidiasis,Vaginal Shingles Athlete's foot Cutaneous candidiasis
Ingredients
Ketoconazole
Drug Actions
Antifungal broad spectrum

Drugs with the same active ingredients

C-86 Colposan Eumicel Euronazol Faction Fangan Fitonal Grenfung Gynerium Keduo Ketoconazol fabra Ketolef Ketonazol lafedar Ketozol Micoespec-c Micoral Micoral (ketoconazol) Orifungal Perative Quadion

Overdose

Cream; Cream for external use; Medicinal shampoo; Pills; ShampooSubstance; Substance-powder; Vaginal suppository

In the event of accidental ingestion, supportive and symptomatic measures should be carried out. In order to avoid aspiration, neither emesis nor gastric lavage should be instigated.

No information provided.

Contraindications

Cream; Cream for external use; Medicinal shampoo; Pills; ShampooSubstance; Substance-powder; Vaginal suppository

Known hypersensitivity to ketoconazole or any of the excipients.

Dezor Cream 2% is contraindicated in persons who have shown hypersensitivity to the active or excipient ingredients of this formulation.

Incompatibilities

Not applicable

Undesirable effects

Cream; Cream for external use; Medicinal shampoo; Pills; ShampooSubstance; Substance-powder; Vaginal suppository

The safety of ketoconazole 2% shampoo was evaluated in 2890 subjects who participated in 22 clinical trials. Ketoconazole 2% shampoo was administered topically to the scalp and/or skin. Based on pooled safety data from these clinical trials, there were no ADRs reported with an incidence >1%.

The following table displays ADRs that have been reported with the use of Ketoconazole 2% Shampoo from either clinical trial or postmarketing experiences.

The displayed frequency categories use the following convention:

Very common (>1/10)

Common (>1/100 to <1/10)

Uncommon (>1/1,000 to <1/100)

Rare (>1/10,000 to <1/1,000)

Very rare (<1/10,000)

Not known (cannot be estimated form the available clinical trial data).

System Organ Class

Adverse Drug Reactions

Frequency Category

Uncommon

(>1/1,000 to <1/100)

Rare

(>1/10,000 and <1/1,000)

Not Known

Immune System disorders

Hypersensitvity

Nervous System Disorders

Dysgeusia

Infections and Infestations

Folliculitis

Eye Disorders

Increased lacrimation

Eye irritation

Skin and Subcutaneous Tissue Disorders

Alopecia

Dry skin

Hair texture abnormal

Rash

Skin burning sensation

Acne

Dermatitis contact

Skin disorder

Skin exfoliation

Angioedema

Urticaria

Hair colour changes

General Disorders and Administration Site Conditions

Application site erythema

Application site irritation

Application site pruritus

Application site reaction

Application site hypersensitivity

Application site pustules

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via:

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard.

During clinical trials 45 (5.0%) of 905 patients treated with Dezor Cream 2% and 5 (2.4%) of 208 patients treated with placebo reported side effects consisting mainly of severe irritation, pruritus and stinging. One of the patients treated with Dezor Cream developed a painful allergic reaction.

In worldwide postmarketing experience, rare reports of contact dermatitis have been associated with Dezor Cream or one of its excipients, namely sodium sulfite or propylene glycol.

Preclinical safety data

Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.

Therapeutic indications

Cream; Cream for external use; Medicinal shampoo; Pills; ShampooSubstance; Substance-powder; Vaginal suppository

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.

Dezor Cream 2% is indicated for the topical treatment of tinea corporis, tinea cruris and tinea pedis caused by Trichophyton rubrum, T. mentagrophytes and Epidermophyton floccosum; in the treatment of tinea (pityriasis) versicolor caused by Malassezia furfur (Pityrosporum orbiculare); in the treatment of cutaneous candidiasis caused by Candida spp. and in the treatment of seborrheic dermatitis.

Pharmacotherapeutic group

Imidazole and triazole derivatives

Pharmacodynamic properties

Pharmacotherapeutic group: Imidazole and triazole derivatives

ATC Code: D01AC08

Ketoconazole is an imidazole-dioxolane antimycotic, active against yeasts, including Malassezia and dermatophytes. Its broad spectrum of activity is already well known.

Pharmacokinetic properties

Plasma concentrations of ketoconazole were not detectable after topical administration of Dezor 2% shampoo on the scalp. Plasma levels were detected after topical administration of Dezor 2% shampoo on the whole body.

Name of the medicinal product

Dezor

Qualitative and quantitative composition

Ketoconazole

Special warnings and precautions for use

Cream; Cream for external use; Medicinal shampoo; Pills; ShampooSubstance; Substance-powder; Vaginal suppository

In patients who have been on prolonged treatment with topical corticosteroids, it is recommended that the steroid therapy be gradually withdrawn over a period of 2 to 3 weeks, while using Dezor 2% shampoo, to prevent any potential rebound effect.

Keep out of the eyes. If the shampoo should get into the eyes, they should be bathed with water.

WARNINGS

Dezor Cream 2% is not for ophthalmic use.

Dezor Cream 2% contains sodium sulfite anhydrous, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

PRECAUTIONS General

If a reaction suggesting sensitivity or chemical irritation should occur, use of the medication should be discontinued. Hepatitis (1:10,000 reported incidence) and, at high doses, lowered testosterone and ACTH induced corticosteroid serum levels have been seen with orally administered Dezor; these effects have not been seen with topical Dezor.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

A long-term feeding study in Swiss Albino mice and in Wistar rats showed no evidence of oncogenic activity. The dominant lethal mutation test in male and female mice revealed that single oral doses of Dezor as high as 80 mg/kg produced no mutation in any stage of germ cell development. The Ames'Salmonella microsomal activator assay was also negative.

Pregnancy Teratogenic effects : Pregnancy Category C

Dezor has been shown to be teratogenic (syndactylia and oligodactylia) in the rat when given orally in the diet at 80 mg/kg/day, (10 times the maximum recommended human oral dose). However, these effects may be related to maternal toxicity, which was seen at this and higher dose levels.

There are no adequate and well-controlled studies in pregnant women. Dezor should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether Dezor Cream 2% administered topically could result in sufficient systemic absorption to produce detectable quantities in breast milk. Nevertheless, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in children have not been established.

Effects on ability to drive and use machines

Not relevant

Dosage (Posology) and method of administration

Cream; Cream for external use; Medicinal shampoo; Pills; ShampooSubstance; Substance-powder; Vaginal suppository

For topical administration.

Ketoconazole shampoo 2% is for use in adolescents and adults:

Wash affected areas and leave for 3-5 minutes before rinsing.

Treatment:

Dandruff and seborrhoeic dermatitis:

Wash hair twice weekly for 2-4 weeks.

Tinea versicolor:

Once daily for a maximum of 5 days.

Prophylaxis:

Dandruff and seborrhoeic dermatitis:

Use once every 1-2 weeks.

Tinea versicolor:

Once daily for a maximum of 3 days before exposure to sunshine.

Cutaneous candidiasis, tinea corporis, tinea cruris, tinea pedis and tinea (pityriasis) versicolor: It is recommended that Dezor Cream 2% be applied once daily to cover the affected and immediate surrounding area. Clinical improvement may be seen fairly soon after treatment is begun; however, candidal infections and tinea cruris and corporis should be treated for two weeks in order to reduce the possibility of recurrence. Patients with tinea versicolor usually require two weeks of treatment. Patients with tinea pedis require six weeks of treatment. Seborrheic dermatitis: Dezor Cream 2% should be applied to the affected area twice daily for four weeks or until clinical clearing.

If a patient shows no clinical improvement after the treatment period, the diagnosis should be redetermined.

Special precautions for disposal and other handling

No special requirements

Frequently asked questions

What conditions does Dezor treat?

Dezor is prescribed for a range of fungal and yeast-related skin conditions, including seborrheic dermatitis, athlete's foot, jock itch, cutaneous candidiasis, and vaginal candidiasis, alongside other dermatological infections listed in the structured indication block on this page. As a broad-spectrum antifungal, ketoconazole is positioned against a wide variety of dermatophyte and yeast organisms, which is why the registered indication list spans several distinct skin presentations.

Which active substance is in Dezor?

Dezor contains ketoconazole, classified as a broad-spectrum antifungal. Ketoconazole is a well-established molecule that circulates internationally under a number of different brand names and in several topical and systemic formulations. The same active ingredient is widely available outside the markets where the Dezor brand specifically is registered, often as a generic or under regionally familiar trade names.

Is Dezor sold internationally?

Dezor has a narrow regional footprint, registered in six countries — all within Southeast Asia and the surrounding region: Vietnam, Hong Kong, Indonesia, Thailand, Malaysia, and Singapore. Travellers outside this cluster will generally not encounter the Dezor brand, although ketoconazole-containing products are available in most regulated pharmaceutical markets globally. If your country is not on the list, a local pharmacist can advise on what is stocked there.

Are there other medications with the same active ingredient as Dezor?

Ketoconazole is sold under multiple brand names worldwide, both as topical preparations and in other formulations, and many markets also stock generic ketoconazole. Other molecules within the broader antifungal category exist as well, although they differ in spectrum and clinical positioning and are not freely interchangeable. To identify a local ketoconazole-containing product, search the active ingredient on Pill2Trip or ask a pharmacist in your country.

Should I consult a doctor before taking Dezor?

Yes. Antifungal therapy is calibrated to the specific organism, the site of infection, and the patient's wider medical context, and ketoconazole in particular has formulation-specific considerations that a healthcare provider is best placed to weigh. Prescription requirements for ketoconazole products also differ between countries, which is relevant for travellers and people relocating. Any decision to start, continue, or substitute Dezor should sit with a qualified clinician.

Dezor

Available in 6 countries