Itraconazole (4 brand names, 4 dosage forms, 2 routes)
Available dosage forms: SOLUTION, CAPSULE, INJECTABLE, TABLET.
Routes of administration: ORAL, INJECTION.
Brand Names
- ITRACONAZOLE
- ONMEL
- SPORANOX
- TOLSURA
Indications and Usage
SPORANOX ®(itraconazole) Capsules are indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromisedpatients: 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. SPORANOX ®Capsules are also indicated for the treatment of the following fungal infections in non-immunocompromisedpatients: Onychomycosis of the toenail, with or without fingernail involvement, due to dermatophytes (tinea unguium), and Onychomycosis of the fingernail due to dermatophytes (tinea unguium). Prior to initiating treatment, appropriate nail specimens for laboratory testing (KOH preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis of onychomycosis. (See CLINICAL PHARMACOLOGY: Special Populations, CONTRAINDICATIONS, WARNINGS, and ADVERSE REACTIONS: Postmarketing Experiencefor more information.)
Dosage and Administration
SPORANOX ®(itraconazole) Capsules should be taken with a full meal to ensure maximal absorption. SPORANOX ®(itraconazole) Capsules must be swallowed whole. SPORANOX ®Capsules is a different preparation than SPORANOX ®Oral Solution and should not be used interchangeably.
Adverse Reactions
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. SPORANOX ® 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. If clinical signs or symptoms develop that are consistent with liver disease, treatment should be discontinued and liver function testing performed. The risks and benefits of SPORANOX ® use should be reassessed. (See WARNINGS: Hepatic Effects and PRECAUTIONS: Hepatotoxicity and Information for Patients.)
Mechanism of Action
In vitrostudies have demonstrated that itraconazole inhibits the cytochrome P450-dependent synthesis of ergosterol, which is a vital component of fungal cell membranes.
Overdosage
Itraconazole is not removed by dialysis. In the event of accidental overdosage, supportive measures should be employed. Contact a certified poison control center for the most up to date information on the management of SPORANOX ®Capsules overdosage (1-800-222-1222 or www.poison.org). In general, adverse events reported with overdose have been consistent with adverse drug reactions already listed in this package insert for itraconazole. (See ADVERSE REACTIONS.)