Itraconazole

What it is and how it works

Mechanism class: Cytochrome P450 3A4 Inhibitors · P-Glycoprotein Inhibitors · Breast Cancer Resistance Protein Inhibitors

Indications

INDICATIONS AND USAGE Itraconazole capsules are indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised patients: Blastomycosis, pulmonary and extrapulmonary Histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis, and 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.

Dosage and administration (summary)

DOSAGE AND ADMINISTRATION Itraconazole capsules should be taken with a full meal to ensure maximal absorption. Itraconazole capsules must be swallowed whole. Itraconazole capsules are a different preparation than itraconazole oral solution and should not be used interchangeably. Treatment of Blastomycosis and Histoplasmosis: The recommended dose is 200 mg once daily (2 capsules). If there is no obvious improvement, or there is evidence of progressive fungal disease, the dose should be increased in 100-mg increments to a maximum of 400 mg daily. Doses above 200 mg/day should be given in two divided doses. Treatment of Aspergillosis: A daily dose of 200 to 400 mg is recommended.

Contraindications

CONTRAINDICATIONS Congestive Heart Failure: Itraconazole capsules should not be administered for the treatment of onychomycosis in patients with evidence of ventricular dysfunction such as congestive heart failure (CHF) or a history of CHF (see BOXED WARNING , WARNINGS , PRECAUTIONS : Drug Interactions-Calcium Channel Blockers, ADVERSE REACTIONS : Post-marketing Experience, and CLINICAL PHARMACOLOGY : Special Populations) .

Warnings and precautions

WARNINGS Hepatic Effects: Itraconazole has been associated with rare cases of serious hepatotoxicity, including liver failure and death. Some of these cases had neither pre-existing liver disease nor a serious underlying medical condition, and some of these cases developed within the first week of treatment. If clinical signs or symptoms develop that are consistent with liver disease, treatment should be discontinued and liver function testing performed.

Storage and supply

HOW SUPPLIED Itraconazole capsules USP, 100 mg, are supplied as a hard gelatin capsule filled with white to off-white pellets having “AMNEAL” printed on blue opaque cap and “630” on blue transparent body in black ink. They are available as follows: Bottles of 30: NDC 65162-630-03 Store at 20° to 25°C (68° to 77°F).

Source: Itraconazole (Itraconazole) — US FDA prescribing information, 2026-07-22, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.