Itraconazole: clinical trials recruiting now

FDA drug label

FDA-approved

Yes. Itraconazole appears in the FDA drug-label database. Marketed as ITRACONAZOLE.

Drug class

Azole Antifungal (FDA established pharmacologic class)

Mechanism of action

Cytochrome P450 3A4 Inhibitors; P-Glycoprotein Inhibitors; Breast Cancer Resistance Protein Inhibitors (as stated on the FDA label)

Boxed warning

The FDA label for Itraconazole carries a boxed warning (the FDA's most serious warning). See the full label for details.

FDA-approved use

Itraconazole capsules are indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised patients: 1. Blastomycosis, pulmonary and extrapulmonary 2. Histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non- meningeal histoplasmosis, and 3. Aspergillosis, pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to amphotericin B therapy. Specimens for fungal cultures and other relevant laboratory studies (wet mount, histopathology, serology) should be obtained before therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, antiinfective therapy should be adjusted accordingly. Itraconazole capsules are also indicated for the treatment of the following fungal infections in non-immunocompromised patients: 1. Onychomycosis of the toenail, with or without fingernail involvement, due to dermatophytes (tinea unguium), and 2. Onychomycosis of the fingernail due to dermatophytes (tinea unguium). Prior to initiating treatment, appropriate nail specimen…

FDA label via openFDA