SPORANOX ORAL SOLUTION Dosage & Rx Info

Sporanox Oral Solution Generic Name & Formulations

Legal Class

General Description

Itraconazole 10mg/mL; cherry-caramel flavor.

Pharmacological Class

Azole antifungal.

How Supplied

Caps—30; Oral soln—150mL

Manufacturer

Janssen Pharmaceuticals, Inc.

Generic Availability

YES

Mechanism of Action

In vitro studies have demonstrated that itraconazole inhibits the cytochrome P450-dependent synthesis of ergosterol, which is a vital component of fungal cell membranes.

Sporanox Oral Solution Indications

Indications

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

Sporanox Oral Solution Dosage and Administration

Adult

Caps and soln are not interchangeable. Take on empty stomach. Swish and swallow 10mL at a time. Oropharyngeal: 200mg (20mL) daily for 1–2 weeks; fluconazole-resistant: 100mg (10mL) twice daily. Esophageal: 100mg daily; doses up to 200mg/day may be used. Treat for at least 3 weeks, continue 2 weeks after symptoms resolve.

Children

Not established.

Sporanox Oral Solution Contraindications

Contraindications

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, finerenone, voclosporin. 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. Concomitant venetoclax in those with CLL/SLL during the dose initiation and ramp-up phase of venetoclax.

Sporanox Oral Solution Boxed Warnings

Boxed Warning

Congestive heart failure and cardiac effects. Drug interactions.

Sporanox Oral Solution Warnings/Precautions

Warnings/Precautions

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. Reduced gastric acidity, achlorhydria (eg, in HIV): reduced capsule bioavailability; cola drink has shown to increase absorption. Discontinue if neuropathy or hearing loss occurs. Immunocompromised: adjust dose based on clinical response. Cystic fibrosis: switch to alternative therapy if no response. Renal impairment. Elderly. Advise females of reproductive potential to use highly effective contraception during and for 2 months after therapy. Pregnancy. Nursing mothers: not recommended.

Sporanox Oral Solution Pharmacokinetics

Absorption

Peak plasma concentrations are reached within 2–5 hours. Absolute oral bioavailability: ~55%.

Distribution

Apparent volume of distribution: >700 L. Plasma protein bound: 99.8%.

Metabolism

Hepatic (CYP3A4).

Elimination

Fecal (54%), renal (35%). Half-life: 16–28 hours.

Sporanox Oral Solution Interactions

Interactions

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, contraceptives (eg, 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.

Sporanox Oral Solution Adverse Reactions

Adverse Reactions

Nausea, rash, vomiting, edema, headache, diarrhea, fatigue, fever, upper respiratory symptoms, pruritus; hepatotoxicity (may be serious), CHF, neuropathy, hearing loss.

Sporanox Oral Solution Clinical Trials

See Literature

Sporanox Oral Solution Note

Not Applicable

Sporanox Oral Solution Patient Counseling