Monograph

D01AC08 - Ketoconazole

Propably not porphyrinogenic

Rationale

Ketoconazole (ATC code: D01A C08) for topical administration is safety classified as Probably not porphyrinogenic because of minimal hepatic exposure. For more details of the metabolism of ketoconazole please refer to the monograph of ketoconazole for systemic use (ATC code: J02A B02).

Therapeutic characteristics

Ketoconazole cream is indicated for the treatment of seborrheic eczema. Ketoconazole shampoo is indicated for the treatment of seborrheic dermatitis and dandruff on the scalp.

Hepatic exposure

Insignificant

Metabolism and pharmacokinetics

Plasma concentrations of ketoconazole were not detectable after topical administration of ketoconazole cream in adults on the skin. In one study in infants with seborrhoeic dermatitis (n = 19), where approximately 40 g of ketoconazole cream was applied daily on 40 % of the body surface area, plasma levels of ketoconazole were detected in 5 infants, ranging from 32 to 133 ng/mL (SPC), which is equivalent to < 1 ÂµM hepatic exposure.

IPNet drug reports

Uneventful use reported in 1 patient with acute porphyria.

References

#	Citation details	PMID
*	Summary of Product Characteristics
1.	The electronic Medicines Compendium (emc). Summary of Product Characteristics (SPC). Ketoconazole.

Citation details

PMID

Summary of Product Characteristics

The electronic Medicines Compendium (emc). Summary of Product Characteristics (SPC). Ketoconazole.

Similar drugs

Explore alternative drugs in similar therapeutic classes D01A / D01AC or go back.

Tradenames and packages

From some sources, we get a list of packages (United Kingdom, Ireland, Estonia). Other sources contain more or less "clean" versions of the trade name (Denmark, Finland, Iceland, Lithuania, Norway). What you see here is the raw data we get from each country, so there will appear to be duplicates. The bold names are the searchable terms. The gray names that follow are all mapped to the bolded term.

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Netherlands

Ketoconazol · Ketoconazol Aurobindo Shampoo 20 mg/g, shampoo · Ketoconazol BModesto 20 mg/g, crème · Ketoconazol CF 20 mg/g, crème · Ketoconazol Double-e Pharma 20 mg/g, shampoo · Ketoconazol ERC 20 mg/g, shampoo · Ketoconazol Eureco-Pharma 20 mg/g, crème · Ketoconazol Medcor 20 mg/g, shampoo · Nizoral · Nizoral 20 mg/g, creme · Nizoral crème 20 mg/g, crème

Belgium

Nizoral · Nizoral 20 mg/g shampooing

United Kingdom

Boots Anti-Dandruff · Boots Anti-Dandruff 2% shampoo · Daktarin Gold · Daktarin Gold 2% cream · Daktarin Intensiv · Daktarin Intensiv 2% cream · Dandrazol · Dandrazol 2% shampoo · Dandrazol Anti-dandruff · Dandrazol Anti-dandruff 2% shampoo · Ketoconazole · Ketoconazole 2% shampoo · Ketopine · Ketopine 2% shampoo · Nizoral · Nizoral 2% cream · Nizoral 2% shampoo · Nizoral anti-dandruff · Nizoral anti-dandruff 2% shampoo · Nizoral Dandruff · Nizoral Dandruff 2% shampoo · Nizorelle · Nizorelle 1% shampoo

Denmark