SPORANOX ORAL SOLUTION

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Generic Name for SPORANOX ORAL SOLUTION Itraconazole 10mg/mL; cherry-caramel flavor. Legal Classification: Rx Pharmacological Class for SPORANOX ORAL SOLUTION Azole. Manufacturer of SPORANOX ORAL SOLUTION Centocor Ortho Biotech Inc.

Indications for SPORANOX ORAL SOLUTION

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.

Adult dose for SPORANOX ORAL SOLUTION

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.

Children's dosing for SPORANOX ORAL SOLUTION

Not recommended. Doses of 5mg/kg per day for 2 weeks have been used; see literature.

Also:

Contraindications for SPORANOX ORAL SOLUTION

Concomitant cisapride, pimozide, nisoldipine, quinidine, dofetilide, triazolam, levacetylmethadol, ergots, or oral midazolam, possibly others metabolized by CYP3A4. Suspend statins metabolized by CYP3A4 (eg, lovastatin, simvastatin) 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.

Warnings/Precautions for SPORANOX ORAL SOLUTION

Use appropriate formulation; caps and soln are not interchangeable. Confirm diagnosis of onychomycosis with nail specimen. Renal impairment. 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). Elderly. Pregnancy (Cat.C): use appropriate contraception during and for 2 months after therapy. Nursing mothers: not recommended.

Interactions for SPORANOX ORAL SOLUTION

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, atorvastatin, cerivastatin, glucocorticoids (eg, budesonide, dexamethasone, methylprednisolone), vinca alkaloids, docetaxel, busulfan, others metabolized by CYP3A4 (eg, halofantrine, alfentanil, buspirone, cilostazole, eletriptan, fluticasone, trimetrexate, fentanyl). 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 for SPORANOX ORAL SOLUTION

GI upset, edema, rash, fatigue, fever, headache, dizziness, hepatotoxicity, liver failure, CHF, hypokalemia.

How is SPORANOX ORAL SOLUTION supplied?

Caps—30
Caps PulsePak—28
Oral soln—150mL

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