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Itraconazole is authorised in the world under the following brand names: Hyphanox, Itrizole, Oriconazole, Sporal, Sporanos, Sporanox, Sporonox, Triasporn.

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Itraconazole, a synthetic triazole derivative, is an azole antifungal agent.

Drug Interactions

Itraconazole Drug Interactions

Antiarrhythmic Agents

Concomitant use of quinidine or dofetilide (antiarrhythmics that increase the QT interval) and itraconazole is contraindicated. Administration of itraconazole with quinidine or dofetilide would be expected to increase plasma concentrations of the antiarrhythmic agent which could result in serious adverse cardiovascular effects. Life-threatening cardiac dysrhythmias and/or sudden death have occurred in patients receiving quinidine concomitantly with itraconazole and/or other drugs that inhibit the CYP3A4 enzyme.

Antilipemic Agents

Concomitant use of hydroxymethylglutaryl-CoA (HMG-CoA) reductase inhibitors (e.g., atorvastatin, cerivastatin, lovastatin, simvastatin) and itraconazole may increase plasma concentrations of these antilipemic agents resulting in increased effects and increased risk of toxicity (e.g., myopathy including rhabdomyolysis).

Concomitant use of itraconazole and these antilipemic agents is contraindicated.

Astemizole and Terfenadine

Concomitant use of itraconazole and astemizole or terfenadine (drugs no longer commercially available in the US) is contraindicated. Rare cases of serious adverse cardiovascular effects, including death, ventricular tachycardia, and atypical ventricular tachycardia (torsades de pointes), have occurred in patients receiving itraconazole and terfenadine concomitantly. Similar effects have been reported when ketoconazole, a structurally similar antifungal agent, was used concomitantly with terfenadine. The antifungal agents appear to inhibit the metabolism of astemizole or terfenadine, probably via inhibition of the cytochrome P-450 (CYP) microsomal enzyme system, resulting in increased plasma concentrations of unchanged drug (to measurable levels) and reduced clearance of the active desmethyl or carboxylic acid metabolite, respectively. Such alterations in the pharmacokinetics of these antihistamines may have been associated with prolongation of the QT and QTc intervals.


Concomitant use of itraconazole and benzodiazepines (e.g., alprazolam, diazepam, oral midazolam, triazolam) may result in increased plasma concentrations of these benzodiazepines that could potentiate and prolong the sedative and hypnotic effects of the drugs. Concomitant use of itraconazole and oral midazolam or triazolam is contraindicated; if midazolam is administered parenterally in patients receiving itraconazole, special precaution and patient monitoring is required since the sedative effect of the benzodiazepine may be prolonged.

Sporanox (Itraconazole)


Concomitant use of itraconazole and cisapride (no longer commercially available in the US) is contraindicated since itraconazole inhibits metabolism of cisapride and such use can result in increased plasma cisapride concentrations and increase the potential for serious adverse cardiovascular effects.


Concomitant use of pimozide and itraconazole is contraindicated. Life-threatening cardiac dysrhythmias and/or sudden death have occurred in patients receiving pimozide concomitantly with itraconazole and/or other drugs that inhibit the CYP3A4 enzyme. Spectrum Itraconazole and its principal metabolite hydroxyitraconazole are active against many fungi, including yeasts and dermatophytes. The antifungal spectrum of activity of the drug is similar to that of fluconazole and ketoconazole, although differences in specific in vitro and in vivo activity on weight and pharmacodynamic bases exist. In addition, itraconazole more consistently exhibits clinically important activity against Aspergillus.

In Vitro Susceptibility Testing

Optimal methods for antifungal agent in vitro susceptibility testing have been difficult to identify and are still being investigated.

Sporanox (Itraconazole)

The National Committee for Clinical Laboratory Standards (NCCLS) has recommended standardized procedures for reference broth dilution antifungal susceptibility testing that can be used to test in vitro susceptibility of yeasts (e.g., Candida, Cryptococcus neoformans) to itraconazole and has established interpretive MIC guidelines for Candida based principally on data involving oropharyngeal candidiasis.

The clinical relevance of these interpretive guidelines in terms of invasive candidal infections is unclear. While routine antifungal agent in vitro susceptibility testing is not recommended, such testing may be warranted under certain circumstances. When the NCCLS reference broth dilution procedure is used to evaluate susceptibility to itraconazole, Candida with MICs of 0.125 mcg/mL or less should be considered susceptible to itraconazole and those with MICs of 1 mcg/mL or greater should be considered resistant to the drug. Candida with MICs of 0.25-0. mcg/mL should be considered to have dose-dependent susceptibility, and measures to ensure adequate drug absorption and plasma itraconazole concentrations of greater than 0.5 mcg/mL may be required for optimal response.


In vitro, the MIC90 of itraconazole for C. guilliermondii, C. krusei, C. parapsilosis, and C. tropicalis is 0.12-1 mcg/mL and the MIC90 of the drug for C. albicans and C. glabrata (formerly Torulopsis glabrata) is 0.12-4 mcg/mL. When the NCCLS standardized procedure was used to test in vitro susceptibility of clinical isolates of C. dubliniensis obtained from patients with or without human immunodeficiency virus (HIV) infection, these strains were inhibited by itraconazole concentrations of 0.03-0.5 mcg/mL. Some strains of C. lusitaniae are inhibited in vitro by itraconazole concentrations of 0.06-0.5 mcg/mL. The MIC90 of itraconazole reported for C. neoformans is 0.5 mcg/mL.

Blastomyces dermatitidis generally is inhibited in vitro by itraconazole concentrations of 0.07 mcg/mL or less. The MIC of itraconazole reported for clinical isolates of Sporothrix schenckii has ranged from 0.03-8 mcg/mL.

Several clinical isolates of Basidiobolus ranarum had itraconazole MICs of 1-8 mcg/mL when the NCCLS reference broth dilution procedure was used. Scopulariopsis, including S. acremonium and S. brevicaulis, generally are resistant to itraconazole in vitro.

Chemistry and Stability


Itraconazole, a synthetic triazole derivative, is an azole antifungal agent. The drug is structurally related to imidazole-derivative azole antifungal agents (e.g., butoconazole, clotrimazole, econazole, ketoconazole, oxiconazole); however, imidazoles have 2 nitrogens in the azole ring (imidazole ring) while itraconazole and other triazoles (e.g., fluconazole, terconazole) have 3 nitrogens in the ring (triazole ring).

For additional information on the chemistry of triazoles, including structure-activity relationships. Itraconazole is a 1:1:1:1 racemic mixture of 4 diastereomers (2 enantiomeric pairs), each possessing 3 chiral centers. The drug occurs as a white to slightly yellowish powder and is insoluble in water and very slightly soluble in alcohol.

Each mL of itraconazole oral solution contains 10 mg of itraconazole solubilized by 400 mg of hydroxypropyl-b-cyclodextrin as a molecular inclusion complex. The oral solution is clear and yellowish in color with a target pH of 2; the solution also contains hydrochloric acid, propylene glycol, sodium hydroxide, sodium saccharin, and sorbitol. Each mL of itraconazole injection contains 10 mg of itraconazole solubilized by 400 mg hydroxypropyl-b-cyclodextrin as a molecular inclusion complex. The injection also contains hydrochloric acid, propylene glycol, and sodium hydroxide for pH adjustment in sterile water for injection and has a pH of 4.5.


Itraconazole capsules should be stored at a controlled room temperature of 15-25°C and protected from light and moisture. Itraconazole oral solution should be stored at 25°C or lower and should not be frozen. Commercially available itraconazole injection should be stored at 25°C or lower and protected from light; freezing should be avoided.

Following dilution of itraconazole injection in the 0.9% sodium chloride injection diluent supplied by the manufacturer, itraconazole injections may be stored at 2-8° or 15-25°C for up to 48 hours. The injection should be protected from light during storage, but may be exposed to normal room light during administration.

The manufacturer states that itraconazole injection should not be diluted with 5% dextrose injection or with lactated Ringer's injection, alone or in combination with any other diluent, since information is not available regarding the physical and/or chemical compatibility of itraconazole with these diluents.

Sporanox (Itraconazole)


Itraconazole Oral Capsules 100 mg Sporanox®, (available in PulsePak® and regular packages) Janssen  Solution 10 mg/mL Sporanox®, (with hydroxypropyl-b-cyclodextrin 400 mg/mL and with propylene glycol) OrthoBiotech Parenteral for injection, 10 mg/mL (250 mg for Sporanox®, (with hydroxypropyl-concentrate, for delivery of 200 mg) b-cyclodextrin 400 mg/mL and IV infusion with propylene glycol and with 50 mL 0.9% sodium chloride for injection diluent and one filtered infusion set) Ortho Biotech

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Synonyms of Itraconazole:

ITC, ITCZ, ITR, Itraconazol [Spanish], Itraconazole, Itraconazolum [Latin], ITZ

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Therapeutic classes of Itraconazole:

Antifungal Agents, Antifungals, Antiprotozoal Agents, Antiprotozoals


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