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Oral ketoconazole has been used clinically as a steroidogenesis inhibitor in men, women, and children at dosages of 200 to 1,200 mg/day. [47] [48] [49] Numerous small studies have investigated the effects of oral ketoconazole on hormone levels in humans. [50]
There is tentative evidence for flutamide in women; however, it is associated with relatively high rates of liver problems and strong recommendations have been made against its use. [14] [35] Like spironolactone, flutamide is typically only used by women. [36] Bicalutamide is another option for the treatment of female pattern hair loss.
In July 2013, the European Medicines Agency's Committee on Medicinal Products for Human Use (CHMP) advised that oral medicines containing Ketoconazole should be suspended due to the high risk of hepatotoxicity outweighing its benefits. The advice does not affect topical ketoconazole products, and the oral use of the drug for Cushing's syndrome.
The first oral antimycotic imidazole, called ketoconazole, was available on the market in 1981. Triazole based drugs came shortly after and quickly gained popularity due to its broader spectrum of antifungal activity and less toxicity. [20] Terconazole was the first triazole-based antifungal drug synthesized for human use.
Cushing's syndrome is a collection of signs and symptoms due to prolonged exposure to glucocorticoids such as cortisol. [4] [9] [10] Signs and symptoms may include high blood pressure, abdominal obesity but with thin arms and legs, reddish stretch marks, a round red face due to facial plethora, [11] a fat lump between the shoulders, weak muscles, weak bones, acne, and fragile skin that heals ...
A reference dose is the United States Environmental Protection Agency's maximum acceptable oral dose of a toxic substance, "below which no adverse noncancer health effects should result from a lifetime of exposure". Reference doses have been most commonly determined for pesticides. The EPA defines an oral reference dose (abbreviated RfD) as:
Research on animal reproduction has indicated that there is a trace of teratogenicity when doses are reduced by 10 times the human recommended dose. [54] There is no sufficient information on human pregnancy at this moment. Use is only recommended when the potential benefits outweigh the potential risks for the pregnant mother and the fetus. [54]
In 2020, the FDA approved a supplemental New Drug Application for efinaconazole topical solution, 10%, which extended the age range included in the product's label to children six years of age and older; it was first approved in 2014, in people aged 18 years of age and older. [12]