Sporanox (itraconazole)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Itraconazole, a synthetic triazole derivative, is an azole antifungal agent.
Oral itraconazole capsules are used in immunocompromised and immunocompetent patients for the treatment of systemic fungal infections, including blastomycosis (pulmonary and extrapulmonary), histoplasmosis (including chronic cavitary pulmonary disease and disseminated, nonmeningeal disease), and aspergillosis (pulmonary and extrapulmonary). Itraconazole oral solution (but not itraconazole capsules) is used for the treatment of oropharyngeal and esophageal candidiasis. Itraconazole (given IV initially (IV preparation no longer commercially available in the US) followed by itraconazole oral solution) has been used for empiric antifungal therapy in febrile neutropenic patients.
Oral itraconazole capsules are used in immunocompetent individuals for the treatment of tinea unguium (onychomycosis) of the toenail and/or fingernail caused by dermatophytes. Itraconazole also is used orally for prevention of serious fungal infections (e.g., coccidioidomycosis, cryptococcosis, histoplasmosis, mucocutaneous candidiasis) in patients with human immunodeficiency virus (HIV) infection+.
Generic name: itraconazole
Pronunciation: (IT-ra-KON-a-zole)
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Sporanox
Indications
The following indications are listed for Sporanox:
- Esophageal Candidiasis
- Oropharyngeal Candidiasis
Also known as: Esophageal Candidosis, Esophageal Moniliasis, Oral Pharynx Candidiasis, Oropharyngeal Candidosis, Oropharyngeal Moniliasis, Oropharynx Candidiasis.
Dosing
Because of differences in oral bioavailability, itraconazole capsules and oral solution should not be used interchangeably.
Itraconazole appears to undergo saturable metabolism in the liver; therefore, increases in dosage can result in more than proportional increases in plasma concentrations.
Dosage of itraconazole capsules should be based on the type and severity of infection, identity of the causative organism, and patient's response to therapy.
To ensure adequate plasma concentrations of itraconazole (especially in patients with life-threatening fungal infections), the Infectious Diseases Society of America (IDSA) and other experts recommend that itraconazole plasma concentrations be determined, usually after 2 weeks of therapy.
Only limited data are available on the use of itraconazole in patients with renal impairment, and the drug should be used with caution in such patients. (See Other Precautions and Contraindications under Cautions: Precautions and Contraindications.)
Only limited data are available on the use of itraconazole in patients with hepatic impairment, and the drug should be used with caution in such patients. (See Precautions Related to Hepatic Effects under Cautions: Precautions and Contraindications.)
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Drug interactions
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There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
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There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
There are no moderate contraindications for this drug.
Adverse reactions
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There are no severe adverse reactions for this drug.
There are no less severe adverse reactions for this drug.
Precautions
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Itraconazole has been shown to be teratogenic and embryotoxic in mice and rats. In addition, although a causal relationship with itraconazole has not been established, congenital abnormalities (skeletal, genitourinary tract, cardiovascular, ophthalmic) and chromosomal and multiple malformations have been reported during postmarketing experience when the drug was used in pregnant women.
There are no adequate and controlled studies evaluating itraconazole in pregnant women, and the drug should be used during pregnancy only when the potential benefits justify the possible risks to the fetus.
For the treatment of onychomycosis, use of itraconazole is contraindicated in pregnant women and also is contraindicated in women contemplating pregnancy. If itraconazole therapy for the treatment of onychomycosis is initiated in a woman of childbearing potential, the first dose of the drug should be given on the second or third day of the next normal menstrual period and measures should be taken to ensure that effective contraception is continued throughout itraconazole therapy and for 2 additional months following discontinuance of the drug.
In reproduction studies, itraconazole caused a dose-related increase in maternal toxicity, embryotoxicity, and teratogenicity in rats at dosages of approximately 40-160 mg/kg daily (5-20 times the maximum recommended human dosage) and in mice at dosages of approximately 80 mg/kg daily (10 times the maximum recommended human dosage). Teratogenicity consisted of major skeletal defects in rats and encephaloceles and/or macroglossia in mice.
Itraconazole is distributed into human milk and the expected benefits of itraconazole for the nursing woman should be weighed against the potential risk to the infant from exposure to the drug. Because of the potential for transmission of HIV to an uninfected child, the US Centers for Disease Control and Prevention (CDC) currently recommends that HIV-infected women not breastfeed infants.
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ICD codes
No ICD codes are available for this drug.
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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