See the DrugPatentWatch profile for ketoconazole
Ketoconazole is an imidazole antifungal medication used to treat various fungal infections [1]. It is available in different formulations, including oral tablets and topical creams, shampoos, and foams [2, 3].
Why is ketoconazole sometimes restricted for oral use?
Oral ketoconazole is no longer recommended for the treatment of fungal infections in many regions, including the United States and Europe, due to serious risks of liver injury [4, 5]. The U.S. Food and Drug Administration (FDA) has issued warnings about these risks, and the medication's use for non-fungal conditions has also been discontinued [4].
What are the common uses for ketoconazole shampoo and cream?
Topical formulations of ketoconazole, such as shampoos and creams, are still widely used for treating fungal skin conditions [2, 3]. These include dandruff (seborrheic dermatitis), fungal infections of the scalp, and certain skin infections caused by yeast [3, 6].
How does ketoconazole work against fungi?
Ketoconazole functions by inhibiting the synthesis of ergosterol, a vital component of fungal cell membranes [1]. This disruption weakens the fungal cell membrane, leading to cell death and controlling the fungal infection [1].
What are the side effects of ketoconazole?
While topical formulations are generally well-tolerated, potential side effects can include skin irritation, itching, or redness [3]. Oral ketoconazole is associated with more significant side effects, including nausea, vomiting, abdominal pain, and, most critically, severe liver damage, which can be life-threatening [4, 5].
When does the patent for ketoconazole expire?
Ketoconazole is an older medication, and its original patents have long since expired, allowing for the development of generic versions [7].
What other antifungal medications are available?
A range of other antifungal medications exist, including azoles like fluconazole and itraconazole, as well as echinocandins and polyenes, which are used to treat different types of fungal infections [8]. The choice of antifungal medication depends on the specific fungal pathogen, the site and severity of infection, and the patient's overall health [8].
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**Sources:
[1] https://www.nhs.uk/medicines/ketoconazole/
[2] https://www.webmd.com/drugs/2/drug-2576/ketoconazole-oral/details
[3] https://www.nhs.uk/medicines/ketoconazole-cream-and-shampoo/
[4] https://www.fda.gov/drugs/postmarket-drug-safety-information-for-patients-and-providers/drug-safety-communication-fda-recommends-against-use-ketoconazole-oral-tablets-treat-certain-fungal
[5] https://www.ema.europa.eu/en/medicines/human/referrals/ketoconazole-oral
[6] https://www.drugs.com/condition/seborrheic-dermatitis.html
[7] https://www.drugpatentwatch.com/
[8] https://www.cdc.gov/fungal/diseases/treatment.html