Generic Name and Formulations:
Itraconazole 100mg; caps.
Janssen Pharmaceuticals, Inc.
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.
Caps and soln are not interchangeable. Swallow whole. Take with full meal. 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 three times daily for 1st 3 days; treat for at least 3 months until resolved. Onychomycosis (confirm diagnosis with nail specimen): toenails: 200mg once daily for 12 consecutive weeks; fingernail only: 200mg twice daily for 1 week, then 3 weeks off, then 200mg twice daily for 1 more week.
Treatment of onychomycosis in CHF, pregnancy, or contemplating pregnancy. Concomitant methadone, disopyramide, dofetilide, dronedarone, quinidine, isavuconazole, ergots, irinotecan, lurasidone, oral midazolam, pimozide, triazolam, felodipine, nisoldipine, ivabradine, ranolazine, eplerenone, cisapride, naloxegol, lomitapide, lovastatin, simvastatin, avanafil, ticagrelor. Concomitant colchicine, fesoterodine, or solifenacin in renal/hepatic impairment. Concomitant eliglustat in poor or intermediate CYP2D6 metabolizers or those taking strong or moderate CYP2D6 inhibitors.
Not for treatment of onychomycosis in patients with ventricular dysfunction (eg, CHF). CHF risk (eg, ischemic/valvular disease, COPD, renal failure, edema); monitor and discontinue if occurs. Monitor for signs/symptoms of liver dysfunction; discontinue and perform LFTs if develop. Discontinue if neuropathy or hearing loss occurs. Reduced gastric acidity, achlorhydria (eg, in HIV): reduced capsule bioavailability; cola drink has shown to increase absorption. Cystic fibrosis: switch to alternative therapy if no response. Renal impairment. Elderly. Pregnancy (Cat.C): use effective contraception during and for 2 months after therapy. Nursing mothers: not recommended.
See Contraindications. Serious cardiac effects with cisapride, pimozide, methadone, quinidine, others. Concomitant alfuzosin, silodosin, tamsulosin, fentanyl, apixaban, rivaroxaban, vorapaxar, antineoplastics (see full labeling), simeprevir, aliskiren, riociguat, sildenafil or tadalafil (for PAH), everolimus, sirolimus, IV temsirolimus, salmeterol, darifenacin, vardenafil, colchicine, conivaptan, tolvaptan, regorafenib, saccharomyces boulardii: not recommended during and 2 weeks after itraconazole. Avoid itraconazole for more than 2 weeks during bedaquiline therapy. Rifabutin, carbamazepine, lumacaftor/ivacaftor: avoid 2 weeks before, during, and 2 weeks after itraconazole. Avoid isoniazid, rifampicin, phenobarbital, phenytoin, efavirenz, nevirapine 2 weeks before and during itraconazole therapy. Potentiates alfentanil, buprenorphine, oxycodone, sufentanil, digoxin, clarithromycin, trimetrexate, cilostazol, dabigatran, warfarin, repaglinide, saxagliptin, praziquantel, eletriptan, antineoplastics (see full labeling), antipsychotics, anxiolytics, hypnotics, zopiclone, daclatasvir, indinavir, maraviroc, nadolol, diltiazem, other dihydropyridines, verapamil, bosentan, guanfacine, aprepitant, loperamide, netupitant, budesonide, ciclesonide, dexamethasone, fluticasone, methylprednisolone, cyclosporine, tacrolimus, atorvastatin, venlafaxine, fesoterodine, solifenacin, dutasteride, oxybutynin, sildenafil, tadalafil, tolterodine, eliglustat, oral alitretinoin, cabergoline, cannabinoids, cinacalcet, ivacaftor; monitor, may need to reduce dose of these. Concomitant artemether-lumefantrine, quinine, cobicistat, elvitegravir (ritonavir-boosted), ritonavir, saquinavir (unboosted), tenofovir disoproxil fumarate, dienogest, ulipristal; monitor for adverse events. Antagonizes meloxicam; increase dose if necessary. Potentiated by ciprofloxacin, erythromycin, clarithromycin, idelalisib, cobicistat, protease inhibitors, diltiazem, other CYP3A4 inhibitors; monitor, may need to reduce itraconazole dose. Give gastric acid suppressants (eg, antacids, H2 blockers, PPIs) at least 2hrs before or 2hrs after itraconazole caps. Tinnitus or hearing impairment with quinidine. Increased risk of CHF with concomitant CCBs.
Nausea, rash, vomiting, edema, headache, diarrhea, fatigue, fever, upper respiratory symptoms, pruritus; hepatotoxicity (may be serious), CHF, neuropathy, hearing loss.
Caps—30; Caps PulsePak—28; Oral soln—150mL
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