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
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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