Monograph Details
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Infections & Infestations
> Fungal infections
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SPORANOX |
| Manufacturer |
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Janssen Pharmaceutica Products, LP |
| 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 100mg; caps. |
| Also |
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• SPORANOX ORAL SOLUTION
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| Indications |
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Blastomycosis. Histoplasmosis. Aspergillosis where amphotericin B is inappropriate. Onychomycosis of the fingernail or toenail in immunocompetent patients. |
| Children |
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Not recommended. Systemic infections: 3–16yrs: doses of 100mg/day have been used; see literature. |
| Adults |
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Take with full meal. Take with cola drink in achlorhydria or if on concomitant gastric acid suppressants. Treat systemic infections for at least 3 months. Give daily doses >200mg in 2 divided doses. Blastomycosis, histoplasmosis: 200mg once daily, may increase by 100mg increments; max 400mg/day. Aspergillosis: 200–400mg daily. Life-threatening conditions: May give loading dose of 200mg 3 times daily for 1st 3 days. Onychomycosis (toenail): 200mg once daily for 12 consecutive weeks. Onychomycosis (fingernail): 200mg twice daily for 1 week, then 3 weeks off, then 200mg twice daily for 1 more week. |
| 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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