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Medication Written by Pharmacists Reviewed by Doctors

Pharmacy Author: Omudhome Ogbru, PharmD
Medical and Pharmacy Editor: Jay W. Marks, MD

GENERIC NAME: itraconazole

BRAND NAME: Sporanox

DRUG CLASS AND MECHANISM: Itraconazole is an anti-fungal drug in the same class of drugs as fluconazole (Diflucan), ketoconazole (Nizoral), and miconazole (Micatin, Monistat). It prevents growth of several types of fungi by preventing the fungi from producing the membranes that surround the fungal cells. The FDA approved itraconazole in September 1992.

PRESCRIPTION: Yes

GENERIC AVAILABLE: Yes

PREPARATIONS: Capsule: 100 mg; Oral Solution: 10 mg/ml

STORAGE: Capsules should be stored at room temperature, 15-25 C (59-77 F) and protected from light and moisture. Solution should be stored below 25 C (77 C) but not frozen.

PRESCRIBED FOR: Itraconazole is used for the treatment of fungal infections in both HIV- and non-HIV-infected individuals. It is active against fungal infections such as aspergillosis, blastomycosis, histoplasmosis, and candidiasis, as well as fungal infection localized to the toenails and fingernails (onychomycosis). It also is used for treating patients with fever and low white blood cell counts who are likely to develop a fungal infection.

DOSING: The usual recommended dose is 200-400 mg daily as a single dose or two divided doses. Capsules should be taken with a full meal because food improves absorption. The capsule and liquid are not interchangeable, and only the liquid form is used for treating oral candidiasis.

DRUG INTERACTIONS: Itraconazole reduces the liver metabolism (breakdown) of some drugs, resulting in increased blood levels and side effects from the affected drugs. Life threatening adverse effects occurred when itraconazole was combined with cisapride (no longer available in the U.S.), pimozide (Orap), quinidine (Quinaglute, Quinidex), dofetilide (Tikosyn), or levomethadyl (Orlaam). Therefore, itraconazole should not be combined with these drugs. Other drugs whose blood levels are increased by itraconazole include warfarin (Coumadin), tolbutamide, glyburide (Micronase, Diabeta, Glynase), glipizide (Glucotrol), protease inhibitors [for example, indinavir (Crixivan), ritonavir (Norvir), saquinavir (Invirase, Fortovase)], midazolam (Versed), triazolam (Halcion), "statins" (for example, simvastatin or Zocor) and several others.

Itraconazole increases blood levels of certain calcium channel blockers, for example, nisoldipine (Sular) and verapamil (Calan). Such combinations increase the occurrence of congestive heart failure due to itraconazole.

Clarithromycin (Biaxin), erythromycin, indinavir (Crixivan) or ritonavir (Norvir) increase blood levels of itraconazole by reducing its elimination from the liver, resulting in increased side effects of itraconazole.

Carbamazepine (Tegretol), phenobarbital, phenytoin (Dilantin), rifampin (Rifadin), rifabutin (Mycobutin) and isoniazid reduce the blood concentration of oral itraconazole, probably by increasing the elimination of itraconazole by the liver. This may reduce the effectiveness of itraconazole.

Itraconazole tablets require acid from the stomach to dissolve. Therefore, itraconazole should be administered at least two hours before taking antacids or other acid reducing medications such as cimetidine (Tagamet), ranitidine (Zantac) or omeprazole (Prilosec).

PREGNANCY: Ketoconazole has not been adequately studied in pregnant women.

NURSING MOTHERS: Itraconazole is excreted in human milk. Therefore, it probably should not be administered to nursing women or, alternatively, breastfeeding should be discontinued.

SIDE EFFECTS: The most common side effects of itraconazole include nausea, vomiting, diarrhea, rash, edema, fatigue, dizziness. High blood pressure (hypertension) and increased blood triglycerides may also occur. Less common but more serious side effects include hepatitis and congestive heart failure. It is important to report any signs or symptoms that may suggest liver dysfunction so that the appropriate laboratory testing can be done. These signs include unusual fatigue, poor appetite, nausea and/or vomiting, yellowing of the eyes (jaundice), dark urine or pale stool. Itraconazole should not be used for treatment of onychomycosis in patients with a history of heart failure. It should be discontinued if signs and symptoms of heart failure occur. Symptoms of heart failure include fatigue, edema (fluid retention), shortness of breath, nausea, abdominal pain and inability to sleep unless sitting upright. Use of calcium channel blockers may increase the risk of heart failure associated with itraconazole (see drug interactions).


Last Editorial Review: 3/3/2009




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