Ketoconazole

These indications are based on manufacturer information for both originator and generic products. For product specific registered indications, please refer to product specific manufacturer information

Registered South African indications:

• Dermatophyte infections of the skin: tinea corporis, tinea cruris, tinea manus and tinea pedis due to Trichophyton rubrum, Trichophyton mentagrophytes, Micro-sporum canis and Epidermophyton floccosum (cre) 
• Cutaneous candidiasis (cre)
• Tinea (pityriasis) versicolor (cre)
• Infections due to yeast Pityrosporum (e.g. pityriasis versicolor, seborrhoeic dermatitis and pityriasis capitis) (sha)  
• Prophylaxis of seborrheic dermatitis (sha)

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients

Cautions

• Pregnancy
• Breastfeeding
• Abrupt withdrawal
• Avoid contact with eyes
• Prolonged treatment

Forms avail. in SA and covered in this monograph: sha, cre

Infections caused by Dermatophytes (e.g. Trichophyton spp., Epidermophyton floccosum, Microsporum spp.); Yeasts (e.g. Candida sp., Malassezia furfur)

General dosing range

• Topical (sha): Apply small quantity to wet skin/hair, leave for 3-5min then rinse, dly
• Topical (cre): Apply small quantity to affected area(s), dly; Treatment duration: Until a few days after disappearance of symptoms

Specific doses based on individual indications

Please note that the dosages below should be used in combination with regional guidelines, taking into account local antibiotic sensitivities

Pityriasis versicolor

• Topical (sha): Apply small quantity to wet skin/hair, leave for 3-5min then rinse, dly; Treatment duration: 5 days

Seborrhoeic dermatitis
Pityriasis Versicolor

• Topical (sha): Apply small quantity to wet skin/hair, leave for 3-5min then rinse, twice weekly; Treatment duration: 2-4 weeks

Prophylactic seborrhoeic dermatitis

• Topical (sha): Apply small quantity to wet skin/hair, leave for 3-5min then rinse, weekly

Tinea versicolor
Yeast infection

• Topical (cre): Apply small quantity to affected area(s), dly; Treatment duration: 2-3 weeks

Tinea cruris

• Topical (cre): Apply small quantity to affected area(s), dly; Treatment duration: 2-4 weeks

Tinea corporis

• Topical (cre): Apply small quantity to affected area(s), dly; Treatment duration: 3-4 weeks

Tinea Pedis

• Topical (cre): Apply small quantity to affected area(s), dly; Treatment duration: 4-6 weeks

Not established for use in children below 12 years

Pregnancy

• Caution
• There are no adequate and well-controlled studies in pregnant women
• Data on a limited number of exposed pregnancies indicate no adverse effects of topical ketoconazole on pregnancy or on the health of the foetus/newborn child. Animal studies have shown reproductive toxicity at doses that are not relevant to the topical administration of ketoconazole. Plasma concentrations of ketoconazole were not detectable after topical administration of ketoconazole to the scalp non-pregnant humans. Plasma levels were detected after topical administration of ketoconazole on the whole body. There are no known risks associated with the use of ketoconazole in pregnancy

Breastfeeding

• Caution
• There are no adequate and well-controlled studies in breastfeeding women. No effects on the breastfed newborn/infant are anticipated. There are no known risks associated with the use of ketoconazole during breastfeeding

Renal Impairment

• No dose adjustment recommended

Hepatic Impairment

• No dose adjustment recommended

Elderly

• No dose adjustment recommended

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Dysgeusia

Skin and Subcutaneous Tissue Disorders

• Angioedema
• Urticaria
• Hair colour changes
• Acne
• Contact dermatitis
• Alopecia
• Dry skin
• Abnormal hair texture 
• Rash
• Burning sensation
• Bullous eruption
• Contact dermatitis
• Skin exfoliation
• Sticky skin
• Urticaria
• Application site reaction

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity
• Folliculitis

Sensory Disorders

• Increased lacrimation
• Eye irritation

No information available

None routine

Ketoconazole is a synthetic imidazole dioxolane, which has antimycotic activity against dermatophytes. Ketoconazole acts at the level of the CYP450 system to inhibit the conversion of lanosterol to ergosterol. Decreased ergosterol levels result in cell wall defects and thus increased fungal cellular permeability. It also acts through several other mechanisms including inhibition of several fungal enzymes that results in accumulation of toxic concentrations of hydrogen peroxide, inhibition of trigylceride and phospholipid synthesis and inihibition of yeast transformation into mycelial forms. 

Spectrum of activity: Dermatophytes (e.g. Trichophyton spp., Epidermophyton floccosum, Microsporum spp.); Yeasts (e.g. Candida sp., Malassezia furfur)

Cream (per g) 20mg

• Ketazol (Pharmacare)
• Nizcreme (Janssen) originator

Shampoo (per ml) 20mg

• Adco-Dermed (Adcock)
• Kez shampoo (Pharma Dynamics)
• Nizshampoo (Johnson & Johnson) originator

Also available in the following form: Tablet