Sporanox (itraconazole) is a broad-spectrum triazole antifungal agent indicated for the treatment of systemic fungal infections. It works by inhibiting the synthesis of ergosterol, a critical component of 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, making it a first-line choice for clinicians managing invasive mycoses. Its bioavailability is enhanced when taken with food, particularly a full meal, optimizing systemic absorption and clinical efficacy.

Features

• Active ingredient: Itraconazole 100 mg per capsule
• Formulations: Oral capsules and solution
• Mechanism: Inhibition of fungal cytochrome P450-dependent ergosterol synthesis
• Spectrum: Broad activity against dermatophytes, yeasts, and molds
• Administration: Once or twice daily dosing, depending on indication

Benefits

• Effectively treats severe systemic fungal infections including histoplasmosis, blastomycosis, and aspergillosis
• High oral bioavailability when administered correctly with food
• Demonstrates fungistatic and fungicidal activity depending on the pathogen
• Suitable for both immunocompetent and immunocompromised patients
• Available in multiple formulations to accommodate different patient needs
• Well-established safety profile with extensive clinical use history

Common use

Sporanox is primarily prescribed for the treatment of systemic fungal infections such as blastomycosis, histoplasmosis, and aspergillosis in patients who cannot tolerate or have failed amphotericin B therapy. It is also used for fungal infections in immunocompromised patients, including those with HIV/AIDS or undergoing chemotherapy. Additionally, it finds application in treating onychomycosis when topical antifungals are ineffective, though systemic use requires careful monitoring due to potential hepatic effects.

Dosage and direction

The recommended dosage varies by indication and patient status. For systemic fungal infections: 200 mg once daily, increased to 200 mg twice daily if inadequate response. For life-threatening infections: loading dose of 200 mg three times daily for first 3 days, followed by 200-400 mg daily. Must be taken with a full meal to maximize absorption. For oral solution: swish vigorously in mouth and swallow. Treatment duration ranges from 3 months to continued therapy based on clinical response and immunosuppression status. Renal or hepatic impairment requires dosage adjustment.

Precautions

Monitor liver function tests before and during treatment. Discontinue if clinical signs of liver disease develop. Use with caution in patients with cardiac disease or risk factors for heart failure. Avoid concomitant use with drugs that prolong QT interval. Not recommended during pregnancy unless potential benefit justifies potential risk. Use effective contraception during and for 2 months after treatment. May cause hearing loss; monitor auditory function in elderly patients. Caution in patients with hypochlorhydria or achlorhydria as absorption may be reduced.

Contraindications

Contraindicated in patients with known hypersensitivity to itraconazole or any component of the formulation. Should not be administered to patients taking certain medications metabolized by CYP3A4 that can cause serious adverse events, including: cisapride, pimozide, quinidine, dofetilide, levacetylmethadol, ergot alkaloids, lovastatin, simvastatin, and triazolam. Contraindicated in patients with evidence of ventricular dysfunction such as congestive heart failure or history of heart failure. Not for use in treatment of onychomycosis in patients with evidence of ventricular dysfunction.

Possible side effect

Common side effects include nausea (11%), vomiting (5%), diarrhea (4%), abdominal pain (3%), headache (4%), and rash (3%). Less frequent but serious adverse reactions include hepatotoxicity (elevated liver enzymes in 5%, clinical hepatitis in <1%), peripheral neuropathy, hearing loss, and congestive heart failure. Hypokalemia may occur, particularly with high doses. Visual disturbances have been reported. Stevens-Johnson syndrome and anaphylaxis are rare but possible. Most side effects are dose-dependent and reversible upon discontinuation.

Drug interaction

Sporanox is a potent inhibitor of CYP3A4 and P-glycoprotein, resulting in numerous clinically significant interactions. Contraindicated with: cisapride, pimozide, quinidine, HMG-CoA reductase inhibitors (simvastatin, lovastatin), and certain benzodiazepines. Increases concentrations of: calcium channel blockers, cyclosporine, tacrolimus, digoxin, warfarin, protease inhibitors, and many antidepressants. Rifampin, rifabutin, phenytoin, and carbamazepine significantly decrease itraconazole concentrations. Antacids, H2-receptor antagonists, and proton pump inhibitors reduce absorption. Requires careful review of all concomitant medications.

Missed dose

If a dose is missed, take it as soon as remembered unless it is almost time for the next dose. Do not double the dose to make up for a missed dose. Maintain regular dosing schedule. If multiple doses are missed, contact healthcare provider for guidance as treatment efficacy may be compromised, particularly for serious systemic infections. For patients on once-daily dosing, a single missed dose is generally not critical, but consistent adherence is important for optimal therapeutic outcomes.

Overdose

Symptoms of overdose may include enhanced adverse effects including nausea, vomiting, diarrhea, and hepatic toxicity. In cases of significant overdose, symptomatic and supportive care is indicated. Gastric lavage may be considered if presented soon after ingestion. Itraconazole is not dialyzable. Monitor hepatic and renal function, electrolyte levels, and cardiac status. There is no specific antidote. Manage arrhythmias if they occur. Case reports indicate survival after ingestion of up to 3000 mg, but medical supervision is essential for any suspected overdose.

Storage

Store capsules at room temperature (15-30°C/59-86°F) in tightly closed container. Protect from light and moisture. Do not freeze. Oral solution should be stored below 25°C (77°F); do not freeze. Keep out of reach of children. Do not use after expiration date printed on packaging. Once opened, oral solution remains stable for 3 months at room temperature. Do not transfer to other containers. Capsules should be kept in original packaging until use to maintain stability.

Disclaimer

This information is for educational purposes only and does not constitute medical advice. Sporanox is a prescription medication that should only be used under the supervision of a qualified healthcare professional. Individual response to treatment may vary. Always follow your healthcare provider’s instructions regarding dosage, administration, and monitoring. Report any adverse effects to your physician immediately. The full prescribing information contains complete details regarding use, warnings, and precautions.

Reviews

Clinical studies demonstrate Sporanox’s efficacy in treating systemic fungal infections with success rates of 70-85% in immunocompetent patients with blastomycosis or histoplasmosis. In aspergillosis, response rates of 40-60% have been observed. Patients report satisfaction with oral administration compared to intravenous alternatives, though gastrointestinal side effects are commonly noted. Healthcare providers appreciate its broad spectrum but emphasize the necessity of therapeutic drug monitoring and liver function testing. Long-term use requires careful benefit-risk assessment due to potential hepatic and cardiac effects.