Sporanox: Advanced Antifungal Treatment for Systemic Infections
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Sporanox (itraconazole) is a potent, broad-spectrum triazole antifungal agent indicated for the treatment of a wide range of systemic, subcutaneous, and mucosal fungal infections. As a cornerstone of modern antifungal therapy, it offers targeted inhibition of ergosterol synthesis—a critical component of fungal cell membranes—leading to fungistatic or fungicidal activity depending on the pathogen and concentration. Its lipophilic properties and extensive tissue penetration make it particularly effective against deep-seated and recalcitrant fungal infections where other antifungals may fail. This medication represents a critical advancement in medical mycology, providing clinicians with a powerful tool against life-threatening invasive fungal diseases.
Features
- Contains itraconazole 100 mg as the active pharmaceutical ingredient
- Available in capsule and oral solution formulations for flexible dosing
- Demonstrates broad-spectrum activity against Aspergillus, Blastomyces, Histoplasma, and Candida species
- High bioavailability when taken with food, particularly acidic beverages
- Lipophilic composition enables extensive penetration into tissues, skin, and nails
- Metabolized primarily by cytochrome P450 3A4 enzyme system
Benefits
- Effectively treats systemic fungal infections that may be life-threatening without proper intervention
- Provides comprehensive coverage against both common and emerging fungal pathogens
- Offers convenient oral administration compared to intravenous antifungal alternatives
- Demonstrates excellent tissue penetration, reaching infection sites that are difficult to treat
- Shows proven efficacy in immunocompromised patients, including those with HIV/AIDS or undergoing chemotherapy
- Reduces risk of infection recurrence when administered as directed
Common use
Sporanox is primarily indicated for the treatment of blastomycosis, histoplasmosis (including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis), and aspergillosis (pulmonary and extrapulmonary) in patients who are intolerant of or refractory to amphotericin B therapy. It is also used for empirical therapy of febrile neutropenic patients with suspected fungal infections. Additionally, Sporanox is approved for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes, and oropharyngeal and esophageal candidiasis. Off-label uses may include treatment of certain cases of coccidioidomycosis, cryptococcosis, sporotrichosis, paracoccidioidomycosis, and chromoblastomycosis, though these applications require careful medical supervision.
Dosage and direction
Dosage varies significantly based on indication, patient factors, and formulation. For systemic fungal infections: typically 200 mg once daily, may increase to 200 mg twice daily for life-threatening infections. For oropharyngeal candidiasis: oral solution 200 mg daily for 1-2 weeks. For esophageal candidiasis: oral solution 100-200 mg daily for minimum 3 weeks. For onychomycosis: 200 mg once daily for 12 consecutive weeks for toenails, 6 consecutive weeks for fingernails. Must be taken with a full meal to ensure optimal absorption. Capsules should be swallowed whole; oral solution should be swished vigorously in mouth for several seconds before swallowing. Dosage adjustments required in hepatic impairment, and monitoring of serum concentrations may be necessary in serious infections.
Precautions
Hepatotoxicity has been reported, requiring liver function monitoring before and during treatment. Discontinue immediately if clinical signs of liver disease develop. Cardiac dysrhythmias, including potentially fatal ventricular tachycardia, have occurred—avoid in patients with ventricular dysfunction or history of heart failure. Hearing loss, usually reversible, has been reported. Neutropenia and rare cases of severe hypersensitivity reactions require immediate medical attention. Not recommended during pregnancy unless potential benefit justifies potential risk to fetus. Advise women of childbearing potential to use effective contraception during and for two months after treatment. May cause dizziness or blurred vision—caution when operating machinery.
Contraindications
Contraindicated in patients with known hypersensitivity to itraconazole or any component of the formulation. Should not be administered to patients with evidence of ventricular dysfunction such as congestive heart failure or history of heart failure. Coadministration with certain drugs that are highly dependent on CYP3A4 for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated. These include quinidine, dofetilide, levacetylmethadol, methadone, pimozide, cisapride, triazolam, oral midazolam, ergot alkaloids, lovastatin, simvastatin, and elbasvir/grazoprevir. Contraindicated in patients with known hypochlorhydria, including those taking acid suppression therapy, unless administered with an acidic beverage.
Possible side effect
Common side effects (≥1%) include nausea, vomiting, diarrhea, abdominal pain, edema, fatigue, fever, rash, headache, and dizziness. Less common but serious adverse reactions include clinical hepatitis, cholestasis, and hepatic failure; symptomatic ventricular dysfunction and congestive heart failure; peripheral neuropathy; hearing loss; neutropenia; and severe skin reactions including Stevens-Johnson syndrome. Elevated liver enzymes occur in approximately 5% of patients, typically reversible upon discontinuation. Hypokalemia has been reported, particularly at higher doses. Men may experience decreased libido or erectile dysfunction. Visual disturbances including blurred vision may occur but are typically transient.
Drug interaction
Sporanox is a potent inhibitor of cytochrome P450 3A4 and P-glycoprotein, resulting in numerous clinically significant interactions. Contraindicated with drugs that prolong QT interval and are metabolized by CYP3A4. Significantly increases concentrations of calcium channel blockers, certain statins, benzodiazepines, buspirone, busulfan, carbamazepine, cyclosporine, digoxin, disopyramide, halofantrine, indinavir, rifabutin, methylprednisolone, tacrolimus, trimetrexate, warfarin, and vinca alkaloids. Drugs that decrease itraconazole concentrations include rifampin, rifabutin, phenytoin, phenobarbital, carbamazepine, isoniazid, and antacids. Acid-suppressing drugs (H2-receptor antagonists, proton pump inhibitors) significantly reduce absorption of capsules but not oral solution.
Missed dose
If a dose is missed, take it as soon as remembered unless it is almost time for the next scheduled dose. Do not double the dose to make up for a missed dose. Resume the regular dosing schedule. Consistent administration is important for maintaining therapeutic drug levels, particularly in the treatment of systemic fungal infections. If multiple doses are missed, contact healthcare provider for guidance on resuming therapy, as additional monitoring or dosage adjustment may be necessary.
Overdose
In case of suspected overdose, contact poison control center or emergency department immediately. Symptoms may include nausea, vomiting, diarrhea, and hearing loss. There is no specific antidote for itraconazole overdose. Treatment should be supportive and symptomatic. Gastric lavage may be considered if performed soon after ingestion. Administration of activated charcoal may be beneficial. Due to high protein binding and extensive tissue distribution, dialysis is not expected to enhance elimination. Cardiac monitoring is recommended, as QT prolongation and ventricular arrhythmias may occur. Provide supportive care including maintenance of electrolyte balance and monitoring of hepatic and renal function.
Storage
Store capsules at room temperature (15-25°C or 59-77°F) in a dry place, protected from light and moisture. Keep oral solution at room temperature; do not freeze. Keep both formulations in their original container with the cap tightly closed. Do not transfer capsules or solution to other containers. Keep out of reach of children and pets. Do not use after the expiration date printed on the packaging. Properly discard any unused medication that is no longer needed or has expired according to local regulations, preferably through a medicine take-back program.
Disclaimer
This information is provided 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. The prescribing physician should be consulted for diagnosis and treatment of medical conditions. Individual response to medication may vary, and not all side effects are listed here. Full prescribing information should be reviewed before initiating therapy. Healthcare professionals should be aware of the latest clinical information and recommendations for antifungal therapy.
Reviews
Clinical studies have demonstrated Sporanox’s efficacy across multiple indications. In a randomized trial of histoplasmosis in AIDS patients, success rates of 85% were achieved. For aspergillosis, response rates of 39-69% have been reported in salvage therapy. In onychomycosis trials, mycological cure rates reached 70-80% with 12-week therapy. Many clinicians report satisfactory outcomes in difficult-to-treat fungal infections, particularly noting its value as an oral alternative to intravenous amphotericin B. Some specialists express concern regarding drug interactions and monitoring requirements but generally acknowledge its important role in the antifungal armamentarium when used appropriately with proper patient selection and monitoring.