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SPORANOX ORAL SOLUTION
Fungal infections
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Drug Name:

SPORANOX ORAL SOLUTION Rx

Generic Name and Formulations:
Itraconazole 10mg/mL; cherry-caramel flavor.

Company:
Janssen Pharmaceuticals, Inc.

Therapeutic Use:

Indications for SPORANOX ORAL SOLUTION:

Oropharyngeal and esophageal candidiasis (not recommended for initiation of treatment if immediate risk of systemic candidiasis).

Adult:

Take on empty stomach. 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:

Not established. Doses of 5mg/kg per day for 2 weeks have been used; see full labeling.

Contraindications:

CHF. Concomitant methadone, disopyramide, dofetilide, dronedarone, cisapride, pimozide, nisoldipine, quinidine, triazolam, ergots, irinotecan, ivabradine, lurasidone, ranolazine, eplerenone, felodipine, lovastatin, simvastatin, oral midazolam, ticagrelor; and colchicine, fesoterodine, telithromycin, solifenacin (if renal/hepatic impairment). Do not use for onychomycosis if pregnant or contemplating pregnancy.

Warnings/Precautions:

Use appropriate formulation; caps and soln are not interchangeable. Confirm diagnosis of onychomycosis with nail specimen. Renal impairment. Monitor for signs/symptoms of liver dysfunction; discontinue and perform LFTs if develop. Ventricular dysfunction. CHF risk (eg, valvular disease, COPD, renal disease). Discontinue if CHF or neuropathy occurs. Achlorhydria (reduced bioavailability from capsules). Cystic fibrosis patients: switch to alternative therapy if no response. Elderly. Pregnancy (Cat.C): use appropriate contraception during and for 2 months after therapy. Nursing mothers: not recommended.

Interactions:

See Contraindications. Serious cardiac effects with cisapride, pimozide, methadone, quinidine, others. Potentiates triazolam, midazolam, diazepam, alprazolam, cyclosporine, tacrolimus, sirolimus, carbamazepine, digoxin, rifabutin, anticoagulants and coumarin-type drugs, HIV protease inhibitors (eg, ritonavir, indinavir, saquinavir), 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), dabigatran, oxycodone, repaglinide, saxagliptin, others. Potentiated by clarithromycin, erythromycin, ciprofloxacin, indinavir, ritonavir, others that inhibit CYP3A4; monitor closely. Monitor cyclosporine, tacrolimus, phenytoin, digoxin, warfarin, vinca alkaloids, non-nucleoside reverse transcriptase inhibitors. Concomitant tamsulosin, apixaban, rivaroxaban, carbamazepine, dasatinib, nilotinib, aliskiren, everolimus, temsirolimus, salmeterol, sildenafil (for PAH), vardenafil, simeprevir, darifenacin, colchicine, conivaptan, tolvaptan: not recommended. Severe hypoglycemia with oral hypoglycemics; monitor glucose. Antagonizes meloxicam; adjust dose if necessary. Antagonized by phenytoin, phenobarbital, carbamazepine, rifabutin, rifampicin, isoniazid, efavirenz, nevirapine, other CYP3A4 inducers; avoid for 2 weeks before and during itraconazole therapy. May inhibit trimetrexate metabolism. May alter fentanyl plasma levels: fatal respiratory depression possible. 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 1hr before or 2hrs after antacids.

See Also:

SPORANOX

Pharmacological Class:

Azole antifungal.

Adverse Reactions:

Nausea, vomiting, diarrhea, edema, rash, fatigue, fever, headache, dizziness, hepatotoxicity, liver failure, CHF, hypokalemia, hearing loss.

How Supplied:

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

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