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SPORANOX
Fungal infections
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Drug Name:

SPORANOX Rx

Generic Name and Formulations:
Itraconazole 100mg; caps.

Company:
Janssen Pharmaceuticals, Inc.

Therapeutic Use:

Indications for SPORANOX:

Blastomycosis. Histoplasmosis. Aspergillosis in patients who are intolerant of or refractory to amphotericin B. Onychomycosis of the fingernail or toenail in immunocompetent patients.

Adult:

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.

Children:

Not established. Systemic infections: 3–16yrs: doses of 100mg/day 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 ORAL SOLUTION

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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