Monograph
D01AC08 - Ketoconazole |
Propably not porphyrinogenic |
PNP |
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 µM hepatic exposure.
IPNet drug reports
Uneventful use reported in 1 patient with acute porphyria.
Similar drugs
References
| # | Citation details | PMID |
|---|---|---|
| * | Summary of Product Characteristics | |
| 1. | The electronic Medicines Compendium (emc). Summary of Product Characteristics (SPC). Ketoconazole.
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Tradenames
This list comprises raw data collected from different countries.
In some cases, a more comprehensive list of available drug packages is included.
Consequently, very similar terms may therefore appear multiple times.
Bold names are the searchable terms, while the gray names that follow are all mapped to the bolded term.
Note: The cleaning is done automatically by a proprietary algorithm, and it may produce errors.
We strive to improve it continuously.
Ketoconazol · Ketoconazol Aurobindo Shampoo 20 mg/g, shampoo · Ketoconazol BModesto 20 mg/g, cr?me · Ketoconazol CF 20 mg/g, cr?me · Ketoconazol Double-e Pharma 20 mg/g, shampoo · Ketoconazol ERC 20 mg/g, shampoo · Nizoral · Nizoral 20 mg/g, creme · Nizoral cr?me 20 mg/g, cr?me 
Nizoral 20 mg/g shampooing 
FUNGAREST 20 mg/g crema · KETO-CURE 20 mg/ml GEL · KETOCONAZOL ABAMED 20 mg/g CREMA · KETOCONAZOL ABAMED 20 mg/g GEL EFG · Ketoconazol Aristo 20 mg/ml gel efg · Ketoconazol Aristogen 20 mg/g gel efg · Ketoconazol Cinfa 2% gel efg · Ketoconazol Euromedicines 2% gel · Ketoconazol Kern Pharma 20 mg/g Crema · Ketoconazol Korhispana 20 mg/g gel efg · Ketoconazol Sandoz 20 mg/g gel efg · Ketoconazol Sesderma 2% gel efg · KETOCONAZOL VIR 20 mg/ml GEL EFG · KETOISDIN 20mg/g CREMA 
Keto - tis · Ketoconazol · KETOCONAZOL DR. MAX 20 mg/g · KETOCONAZOL FITERMAN 20 mg/g · NIZORAL 20 mg/g · SEBODERM MED 20 mg/ml 
Boots Anti-Dandruff · Daktarin Gold · Daktarin Intensiv · Dandrazol · Dandrazol Anti-dandruff · Ketoconazole · Ketopine · Nizoral · Nizoral anti-dandruff · Nizoral Dandruff · Nizorelle 
Ketoconazole Shampoo Actavis 2 % · Nizoral 
Fungoral 
Nizax Activ · Nizoral · Sinazol · Zoxin-med 
Nizoral 
Dermatin · Fungoral 
Ketoconazol Ratiopharm · Ketokonazol Oriola-KD · Konact · Nizoral 
Ketoconazol-ratiopharm · Mikanisal · Nizoral 
Mycoseb®
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