Sporanox: Effective Antifungal Treatment for Systemic Infections
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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 cell death. This medication is particularly effective against a range of pathogens, including Aspergillus, Blastomyces, and Histoplasma species. Available in oral and intravenous formulations, Sporanox offers flexibility in administration based on clinical need and patient factors. Its use is supported by extensive clinical evidence demonstrating efficacy in both immunocompetent and immunocompromised individuals.
Features
- Active ingredient: Itraconazole 100 mg per capsule
- Formulations: Oral capsules, oral solution, and intravenous injection
- Mechanism: Inhibition of fungal cytochrome P450-dependent ergosterol synthesis
- Spectrum: Broad activity against dermatophytes, yeasts, and molds
- Bioavailability: Enhanced by acidic gastric environment; co-administration with food recommended for capsules
- Half-life: Approximately 21 hours in steady-state conditions
Benefits
- Provides systemic coverage for deep-seated fungal infections unresponsive to topical agents
- High clinical cure rates in invasive aspergillosis, blastomycosis, and histoplasmosis
- Oral bioavailability allows for outpatient treatment in appropriate cases
- Demonstrated efficacy in both immunocompetent and immunocompromised patients
- Flexible dosing regimens adaptable to specific fungal pathogens and infection severity
- Well-established safety profile with extensive post-marketing surveillance data
Common use
Sporanox is primarily indicated for the treatment of systemic fungal infections including pulmonary and extrapulmonary blastomycosis, histoplasmosis (including chronic cavitary pulmonary disease and disseminated non-meningeal histoplasmosis), and aspergillosis in patients who are intolerant 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, though systemic infections represent its primary therapeutic domain.
Dosage and direction
For systemic fungal infections: The recommended dose is 200 mg once daily, which may be increased to 200 mg twice daily in life-threatening situations. Treatment should continue for a minimum of three months and until clinical parameters and laboratory tests indicate that active fungal infection has subsided. For onychomycosis: 200 mg once daily for 12 consecutive weeks. Capsules must be taken with a full meal to ensure optimal absorption. The oral solution should be taken on an empty stomach to maximize bioavailability. For patients with achlorhydria or those taking gastric acid suppressors, co-administration with an acidic beverage (e.g., cola) may be necessary.
Precautions
Hepatic function should be monitored in all patients receiving Sporanox, particularly those with pre-existing liver impairment or those receiving treatment beyond 28 days. Cardiac function should be assessed in patients with risk factors for congestive heart failure. Concomitant use with drugs that prolong QT interval should be avoided. Pregnancy should be excluded before initiation of therapy in women of childbearing potential due to potential teratogenic effects. Adrenal function should be monitored in patients requiring prolonged therapy. Patients should be advised to report any signs of peripheral neuropathy, hearing loss, or visual changes promptly.
Contraindications
Sporanox is contraindicated in patients with known hypersensitivity to itraconazole or any component of the formulation. Concomitant administration with certain drugs metabolized by CYP3A4 is strictly contraindicated, including quinidine, dofetilide, pimozide, levacetylmethadol, cisapride, triazolam, oral midazolam, ergot alkaloids, lovastatin, simvastatin, and elbasvir/grazoprevir. Additional contraindications include ventricular dysfunction such as congestive heart failure (NYHA Classes III and IV), and history of heart failure with past itraconazole use.
Possible side effect
Common adverse reactions (≥1%) include nausea (11%), vomiting (5%), diarrhea (4%), abdominal pain (3%), headache (4%), rash (3%), and edema (4%). Less frequent but clinically significant effects include elevated liver enzymes (2%), hepatitis, hypokalemia, hypertension, and peripheral neuropathy. Rare but serious adverse events include congestive heart failure, Stevens-Johnson syndrome, tinnitus, hearing loss, and anaphylaxis. Most adverse effects are dose-dependent and reversible upon discontinuation of therapy.
Drug interaction
Sporanox is a potent inhibitor of CYP3A4 and P-glycoprotein, resulting in numerous clinically significant interactions. Coadministration with CYP3A4 substrates may increase their plasma concentrations and toxicity risk. Specifically, interactions occur with: anticoagulants (increased warfarin effect), antidiabetics (hypoglycemia with sulfonylureas), benzodiazepines (prolonged sedation), calcium channel blockers (hypotension), HIV protease inhibitors, HMG-CoA reductase inhibitors (increased risk of rhabdomyolysis), and immunosuppressants (cyclosporine, tacrolimus). Dose adjustments and therapeutic drug monitoring are essential when coadministering these medications.
Missed dose
If a dose is missed, it should be taken as soon as possible. However, if it is almost time for the next scheduled dose, the missed dose should be skipped. Patients should not double the dose to make up for a missed dose. Consistent daily administration is important to maintain therapeutic drug levels, particularly given Sporanox’s long half-life. Healthcare providers should educate patients about the importance of adherence to the prescribed dosing schedule for optimal antifungal efficacy.
Overdose
There is no specific antidote for itraconazole overdose. Cases of overdose have reported symptoms including nausea, vomiting, diarrhea, and abdominal pain. Severe overdose may lead to hepatotoxicity, adrenal dysfunction, and electrolyte abnormalities. Management should include supportive measures with gastric lavage if presented within one hour of ingestion. Activated charcoal may be administered. Liver function tests, electrolyte monitoring, and adrenal function assessment are recommended. Hemodialysis is not effective due to high protein binding.
Storage
Store Sporanox capsules at room temperature (15-30°C or 59-86°F) in their original container. Protect from light and moisture. Keep the oral solution at room temperature; do not freeze. The intravenous formulation should be stored at room temperature and protected from light. All formulations should be kept out of reach of children and pets. Do not use beyond the expiration date printed on the packaging. Proper storage ensures stability and efficacy throughout the treatment period.
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. Individual patient response may vary, and treatment decisions should be based on professional clinical judgment. Patients should consult their healthcare provider for complete information about benefits, risks, and appropriate use. Full prescribing information including boxed warnings should be reviewed before initiation of therapy.
Reviews
Clinical studies demonstrate Sporanox’s efficacy with mycological cure rates of 70-80% in blastomycosis and histoplasmosis. In aspergillosis trials, response rates of 60-70% have been observed in salvage therapy. The drug maintains generally favorable physician assessments regarding tolerability and convenience of oral administration. Some clinicians note the need for therapeutic drug monitoring in complex cases. Patient-reported outcomes indicate satisfaction with treatment effectiveness, though some report gastrointestinal side effects as challenging. Overall, Sporanox remains a valuable therapeutic option in the antifungal armamentarium.