Ketoconazole (ketoconazole)
Topical Antifungals Topical Foam (Gram)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Ketoconazole, a synthetic imidazole derivative, is an azole antifungal agent.
Oral ketoconazole has been used as an alternative for the treatment of blastomycosis, chromomycosis (chromoblastomycosis), coccidioidomycosis, histoplasmosis, and paracoccidioidomycosis. Because ketoconazole has been associated with serious adverse effects (e.g., hepatotoxicity, adrenal insufficiency) and drug interactions, the drug should be used for the treatment of these systemic fungal infections only when they are serious or life-threatening, other effective antifungals are not available or not tolerated, and the potential benefits of oral ketoconazole outweigh potential risks of the drug. (See Cautions: Precautions and Contraindications.)
Generic name: ketoconazole
Pronunciation: (kee-toe-CON-uh-zole)
Drug class: Topical Antifungals
Therapeutic class: Dermatological
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Ketoconazole
Indications
The following indications are listed for Ketoconazole:
- Blastomycosis
- Chromoblastomycosis
- Coccidioidomycosis
- Histoplasmosis
- Paracoccidioidomycosis
Also known as: Almeida's Disease, Blastomycotic Infection, Brazilian Blastomycosis, California Disease, Chromomycosis, Coccidioidal Granuloma, Darling's Disease, Gilchrist's Disease, Lutz-Splendore-Almeida Disease, North American Blastomycosis, Paracoccidioidal Granuloma, Posada-Wernicke Disease, Posadas Disease, Posadas Mycosis, South American Blastomycosis.
Dosing
No dosing information is available for this tab.
Ketoconazole is administered orally.
If used in patients receiving a drug that decreases gastric acid output or increases gastric pH, ketoconazole tablets should be administered with an acidic beverage (e.g., non-diet cola) and the acid-reducing drug should be administered at least 1 hour before or 2 hours after ketoconazole. (See Drug Interactions: Drugs Affecting Gastric Acidity.)
To ensure absorption in patients with achlorhydria(see Pharmacokinetics: Absorption), some clinicians have suggested that each 200-mg dose of oral ketoconazole should be administered with an acidic beverage (e.g., Coca-Cola(R), Pepsi(R)) or the dose dissolved in 60 mL of citrus juice; however, this strategy may not be adequate in all patients with achlorhydria and patients should be monitored closely for therapeutic failure.
| Drug label | Dosing type | Instructions |
|---|---|---|
| Ketoconazole 2% Foam | Maintenance | Apply to the affected area(s) by topical route 2 times per day. |
| Drug label | Dosing type | Instructions |
|---|---|---|
| Ketoconazole 2% Foam | Maintenance | Apply to the affected area(s) by topical route 2 times per day. |
Drug interactions
There is no enhanced messaging for this drug.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
There is no enhanced messaging for this drug.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
- No disease contraindications
Adverse reactions
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Rare or Very Rare
- Anaphylaxis
- Angioedema
More Frequent
- Pruritus of skin
- Skin inflammation
- Skin irritation
Rare or Very Rare
- Abnormal hair texture
- Alopecia
- Cheilitis
- Dermatitis due to topical drug
- Dry skin
- Erythema
- Hair discoloration
- Skin rash
- Stinging of skin
Precautions
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No enhanced messaging available.
Ketoconazole should be used during pregnancy only when potential benefits justify possible risks to the fetus.
Ketoconazole has been teratogenic (syndactylia and oligodactylia) when given orally to pregnant rats in a dosage of 80 mg/kg daily (2 times the maximum recommended human oral dosage based on body surface area comparisons). The drug has also been embryotoxic in rats when given orally during the first trimester of gestation in dosages exceeding 80 mg/kg daily and has caused dystocia in rats when given orally during the third trimester of pregnancy in dosages exceeding 10 mg/kg (approximately 25% of the maximum human dosage based on body surface area comparisons). Although these effects may be a reflection of the particular sensitivity of female rats to ketoconazole (maternal toxicity), there are no adequate and controlled studies to date using ketoconazole in pregnant women.
Because ketoconazole is distributed into human milk, lactating women receiving the drug should not breast-feed.
No enhanced messaging available.
ICD codes
| Code | Type | Description |
|---|---|---|
| Seborrheic dermatitis | ||
| L21 | ICD10CM | Seborrheic dermatitis |
| L21.0 | ICD10CM | Seborrhea capitis |
| L21.1 | ICD10CM | Seborrheic infantile dermatitis |
| L21.8 | ICD10CM | Other seborrheic dermatitis |
| L21.9 | ICD10CM | Seborrheic dermatitis, unspecified |
ICD code information from First Databank (FDB).
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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