Monograph Details
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Infections & Infestations
> Fungal infections
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SPORANOX ORAL SOLUTION |
| Manufacturer |
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Ortho Biotech Products, L.P. |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Azole. |
| Generic Name |
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Itraconazole 10mg/mL; cherry-caramel flavor. |
| Also |
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• SPORANOX
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| Indications |
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Oropharyngeal and esophageal candidiasis (not recommended for initiation of treatment if immediate risk of systemic candidiasis). Empiric therapy of febrile neutropenia if fungal infection suspected. |
| Children |
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Not recommended. Doses of 5mg/kg per day for 2 weeks have been used; see literature. |
| Adults |
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Take on empty stomach. Neutropenia: see literature (use IV form first). Swish and swallow 10mL at a time. Oropharyngeal: 200mg daily for 1–2 weeks; fluconazole-resistant: 100mg twice daily. Esophageal: 100–200mg daily. Treat for at least 3 weeks, continue 2 weeks after symptoms resolve. |
| Contraindications |
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Concomitant cisapride, pimozide, quinidine, dofetilide, triazolam, levacetylmethadol, ergots, or oral midazolam, possibly others metabolized by CYP3A4. Suspend statins metabolized by CYP3A4 (eg, lovastatin, simvastatin, atorvastatin) during itraconazole therapy. Reevaluate if CHF symptoms occur. Do not use for onychomycosis if pregnant or contemplating pregnancy, or if ventricular dysfunction symptoms (eg, CHF, history of CHF) occur. |
| Precautions |
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Use appropriate formulation; caps and soln are not interchangeable. Confirm diagnosis of onychomycosis with nail specimen. Hepatic dysfunction; monitor and discontinue if hepatic dysfunction occurs. Ventricular dysfunction. CHF risk (eg, valvular disease, COPD, renal disease). Discontinue if CHF or neuropathy occurs. Achlorhydria (reduced bioavailability from capsules). Pregnancy (Cat.C): use appropriate contraception during and for 2 months after therapy. Nursing mothers: not recommended. |
| Interactions |
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See Contraindications. Serious cardiac effects with cisapride, pimozide, quinidine, others. Concomitant nevirapine, rifabutin, rifampin, others metabolized by CYP3A4: not recommended. Potentiates triazolam, midazolam, diazepam, alprazolam, cyclosporine, tacrolimus, sirolimus, carbamazepine, digoxin, rifabutin, anticoagulants and coumarin-type drugs (monitor PT), HIV protease inhibitors (eg, ritonavir, indinavir, saquinavir), disopyramide, dihydropyridine calcium channel blockers, verapamil, glucocorticoids (eg, budesonide, dexamethasone, methylprednisolone), vinca alkaloids, docetaxel, busulfan, others metabolized by CYP3A4 (eg, alfentanil, buspirone, cilostazole, eletriptan, trimetrexate). Severe hypoglycemia with oral hypoglycemics; monitor glucose. Antagonized by phenytoin, phenobarbital, carbamazepine, rifampin, rifabutin, isoniazid, nevirapine, other CYP3A4 inducers; monitor itraconazole if given concomitantly. Potentiated by clarithromycin, erythromycin, indinavir, ritonavir, others that inhibit CYP3A4. Monitor cyclosporine, tacrolimus, phenytoin, digoxin, potassium, warfarin, vinca alkaloids, non-nucleoside reverse transcriptase inhibitors. Tinnitus or hearing impairment with quinidine. May inhibit polyene antifungals. Calcium channel blockers increase risk of edema; consider dose adjustment. Capsules: antagonized by gastric acid suppressants (eg, H2 blockers, proton pump inhibitors). Take at least 1 hour before or 2 hours after antacids. |
| Adverse Reactions |
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GI upset, edema, rash, fatigue, fever, headache, dizziness, hepatotoxicity, liver failure, CHF, hypokalemia; inj site reactions, vein disorders (inj). |
| How Supplied |
Caps—30
Caps PulsePak—28
Oral soln—150mL |
| Additional Resources |
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• Related Prescribing Note |
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