Sporanox (itraconazole) is a broad-spectrum triazole antifungal agent indicated for the treatment of systemic fungal infections. As a potent inhibitor of fungal cytochrome P450-dependent enzymes, it disrupts ergosterol synthesis in fungal cell membranes, leading to fungal cell death. This oral solution and capsule formulation offers targeted therapeutic action against a wide range of pathogenic fungi, including Aspergillus, Blastomyces, Histoplasma, and dermatophytes. Its lipophilic properties enable excellent tissue penetration, particularly in skin, nails, and organs affected by deep-seated fungal infections. Medical professionals prescribe Sporanox based on confirmed mycological diagnosis and susceptibility testing when appropriate.

Features

• Contains itraconazole 100mg per capsule or 10mg/mL oral solution
• Available in hydroxypropyl-β-cyclodextrin solution for enhanced bioavailability
• Demonstrates broad-spectrum activity against dermatophytes, yeasts, and molds
• Acid-resistant capsules ensure optimal drug release in intestinal tract
• Requires acidic gastric environment for optimal absorption (capsule formulation)
• Exhibits extensive tissue distribution with concentration in skin, nails, and lungs

Benefits

• Effectively treats systemic fungal infections that may be life-threatening in immunocompromised patients
• Provides targeted action against difficult-to-treat dermatophytoses and onychomycosis
• Offers convenient once or twice-daily dosing regimen depending on indication
• Demonstrates superior tissue penetration compared to some other antifungal agents
• Shows fungistatic and fungicidal activity depending on the fungal species
• May be used as sequential therapy following intravenous antifungal treatment

Common use

Sporanox is primarily prescribed for the treatment of blastomycosis, histoplasmosis, and aspergillosis in patients who are intolerant of or refractory to amphotericin B therapy. It is also indicated for onychomycosis of the toenail or fingernail caused by dermatophytes, as well as oral and esophageal candidiasis. Off-label uses include treatment of cryptococcosis, sporotrichosis, paracoccidioidomycosis, and certain cases of dermatophytosis that are extensive or resistant to topical therapy. The selection of Sporanox should be based on appropriate diagnostic procedures, including fungal culture and histopathological examination when indicated.

Dosage and direction

Blastomycosis/Histoplasmosis: 200mg once daily; may increase to 200mg twice daily if no clinical improvement. Continue for at least 3 months.

Aspergillosis: 200mg twice daily; duration based on clinical response (minimum 2-5 months).

Onychomycosis: Pulse therapy: 200mg twice daily for 1 week per month, repeated for 2-3 months (fingernails) or 3-4 months (toenails). Continuous therapy: 200mg daily for 6 weeks (fingernails) or 12 weeks (toenails).

Oral Candidiasis: 200mg daily for 1-2 weeks.

Esophageal Candidiasis: 100-200mg daily for 3 weeks.

Capsules must be taken with a full meal to ensure optimal absorption. The oral solution should be taken on an empty stomach. Dosage adjustments are necessary in hepatic impairment. Monitoring of serum concentrations may be warranted in serious infections or when drug interactions are suspected.

Precautions

Hepatic function should be monitored during treatment, as Sporanox has been associated with rare cases of serious hepatotoxicity, including liver failure and death. Cardiac monitoring is advised in patients with risk factors for congestive heart failure, as negative inotropic effects have been reported. Patients should be advised to report any signs of liver dysfunction (fatigue, anorexia, nausea, vomiting, jaundice, dark urine, or pale stools). Caution is recommended when administering to patients with renal impairment, although the pharmacokinetics of itraconazole are not significantly affected. Peripheral neuropathy has been reported with prolonged use. Audiometric testing may be considered in patients receiving long-term therapy.

Contraindications

Sporanox is contraindicated in patients with known hypersensitivity to itraconazole or any component of the formulation. Concomitant administration with drugs that are highly dependent on CYP3A4 metabolism and which have narrow therapeutic windows is contraindicated, including quinidine, dofetilide, levacetylmethadol, methadone, pimozide, cisapride, triazolam, oral midazolam, ergot alkaloids, lovastatin, simvastatin, and elbasvir/grazoprevir. Administration with strong CYP3A4 inducers such as rifampin, rifabutin, phenobarbital, phenytoin, and carbamazepine is also contraindicated. The drug is contraindicated for the treatment of onychomycosis in patients with evidence of ventricular dysfunction such as congestive heart failure.

Possible side effect

Common adverse reactions (>1%) include nausea, vomiting, diarrhea, abdominal pain, edema, headache, rash, and dizziness. Less frequent but serious side effects may include hepatotoxicity (elevated liver enzymes, hepatitis, liver failure), congestive heart failure, peripheral neuropathy, hearing loss, and Stevens-Johnson syndrome. Laboratory abnormalities may include hypokalemia, decreased hemoglobin, and neutropenia. Men have reported reversible decreased libido and erectile dysfunction. Visual disturbances have been reported rarely. Pediatric patients may experience a higher incidence of some adverse effects including vomiting, diarrhea, fever, and abdominal pain.

Drug interaction

Sporanox is a potent inhibitor of CYP3A4 and P-glycoprotein, resulting in numerous clinically significant drug interactions. It increases concentrations of calcium channel blockers, benzodiazepines, buspirone, busulfan, carbamazepine, cyclosporine, digoxin, disopyramide, HMG-CoA reductase inhibitors, indinavir, rifabutin, methylprednisolone, tacrolimus, vinca alkaloids, and warfarin. Drugs that reduce gastric acidity (H2-receptor antagonists, proton pump inhibitors, antacids) may significantly decrease itraconazole absorption. Concomitant use with CYP3A4 inducers reduces itraconazole concentrations. Interaction with midazolam, triazolam, and quinidine may result in life-threatening events. Comprehensive medication review is essential before initiation.

Missed dose

If a dose is missed, it should be taken as soon as remembered unless it is almost time for the next scheduled dose. In that case, the missed dose should be skipped and the regular dosing schedule resumed. Patients should not take a double dose to make up for a missed one. For once-daily dosing, if remembered within 12 hours of the scheduled time, the dose may be taken. For twice-daily dosing, if remembered within 6 hours, the dose may be taken. Maintaining consistent timing is important for therapeutic drug levels.

Overdose

Symptoms of overdose may include nausea, vomiting, diarrhea, and abdominal pain. Severe overdose may lead to hepatotoxicity, hearing loss, and cardiac effects including QT prolongation. There is no specific antidote for itraconazole overdose. Management should include supportive measures and gastric lavage if presented within one hour of ingestion. Activated charcoal may be administered. Liver function, electrolytes, and ECG should be monitored. Hemodialysis is not effective due to high protein binding. Symptomatic treatment should be provided based on clinical manifestations.

Storage

Capsules should be stored at room temperature (15-30°C or 59-86°F) in a tight container protected from light and moisture. The oral solution should be stored below 25°C (77°F) and not frozen. Keep both formulations out of reach of children. Do not use beyond the expiration date printed on the packaging. The oral solution bottle should be kept tightly closed and used within 3 months after opening. Do not transfer the oral solution to other containers. Protect from direct sunlight and excessive heat.

Disclaimer

This information is provided for educational purposes only and does not constitute medical advice. Sporanox is a prescription medication that should be used only under the supervision of a qualified healthcare professional. The prescribing physician should be consulted for diagnosis and treatment decisions. Individual patient response may vary, and the full prescribing information should be reviewed before administration. This document does not contain all possible information about this medication and should not be used as a substitute for professional medical advice.

Reviews

Clinical studies have demonstrated Sporanox’s efficacy in various fungal infections. In a multicenter trial of blastomycosis, success rates of 90% were observed with itraconazole therapy. For onychomycosis, mycological cure rates range from 70-80% with pulse therapy. Studies in histoplasmosis in AIDS patients showed success rates of 85%. The drug has shown particular value in chronic pulmonary aspergillosis with response rates of 60-70%. Dermatologists report high patient satisfaction with nail clearance rates. Infectious disease specialists note its importance as an oral alternative to amphotericin B in certain systemic fungal infections. Monitoring of serum levels is recommended in serious infections to ensure therapeutic concentrations.