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Sporanox Capsules (itraconazole)

BOXED WARNING

Should not be administered for the treatment of onychomycosis in patients w/ evidence of ventricular dysfunction (eg, CHF, history of CHF). D/C use if signs/symptoms of CHF occur. Contraindicated w/ methadone, disopyramide, dofetilide, dronedarone, quinidine, ergot alkaloids (eg, dihydroergotamine, ergometrine [ergonovine], ergotamine, methylergometrine [methylergonovine]), irinotecan, lurasidone, oral midazolam, pimozide, triazolam, felodipine, nisoldipine, ranolazine, eplerenone, cisapride, lovastatin, simvastatin, ticagrelor, and, in subjects w/ varying degrees of renal or hepatic impairment, colchicine, fesoterodine, telithromycin, and solifenacin; may cause elevated levels of these drugs and may increase or prolong both the pharmacologic effects and/or adverse reactions to these drugs.

THERAPEUTIC CLASS

Azole antifungal

DEA CLASS

RX

INDICATIONS

Treatment of blastomycosis (pulmonary/extrapulmonary), histoplasmosis (eg, chronic cavitary pulmonary disease and disseminated, nonmeningeal histoplasmosis), and aspergillosis (pulmonary/extrapulmonary) if refractory to or intolerant of amphotericin B therapy, in immunocompromised and nonimmunocompromised patients. Onychomycosis of the toenail (w/ or w/o fingernail involvement) and fingernail due to dermatophytes (tinea unguium) in nonimmunocompromised patients.

ADULT DOSAGE

Aspergillosis

Pulmonary/extrapulmonary aspergillosis in patients intolerant or refractory to amphotericin B therapy who are immunocompromised/nonimmunocompromised 

Usual: 200-400mg/day

Blastomycosis

Pulmonary/extrapulmonary blastomycosis in immunocompromised/nonimmunocompromised patients

Usual: 200mg qd
Titrate: May increase in 100mg increments if no improvement or if w/ evidence of progressive fungal disease
Max: 400mg/day

Administer in 2 divided doses for doses >200mg/day

Histoplasmosis

Pulmonary/extrapulmonary histoplasmosis in immunocompromised/nonimmunocompromised patients

Usual: 200mg qd
Titrate: May increase in 100mg increments if no improvement or if w/ evidence of progressive fungal disease
Max: 400mg/day

Administer in 2 divided doses for doses >200mg/day

Onychomycosis

Nonimmunocompromised Patients:
Toenails (w/ or w/o Fingernail Involvement):
Usual:
200mg qd for 12 consecutive weeks

Fingernails Only:
Usual:
2 treatment pulses, each consisting of 200mg bid for 1 week; separate pulses by a 3-week period w/o itraconazole

Life-Threatening Infections

LD: 200mg tid for the first 3 days

Continue treatment for a minimum of 3 months and until infection subsides

ADMINISTRATION

Oral route

Swallow caps whole; take w/ a full meal

HOW SUPPLIED

Cap: 100mg

CONTRAINDICATIONS

Coadministration of a number of CYP3A4 substrates (eg, methadone, disopyramide, dofetilide, dronedarone, quinidine, ergot alkaloids [eg, dihydroergotamine, ergometrine (ergonovine), ergotamine, methylergometrine (methylergonovine)], irinotecan, lurasidone, oral midazolam, pimozide, triazolam, felodipine, nisoldipine, ranolazine, eplerenone, cisapride, lovastatin, simvastatin, ticagrelor, and, in subjects w/ varying degrees of renal or hepatic impairment, colchicine, fesoterodine, telithromycin, and solifenacin). Treatment of onychomycosis in pregnant patients, women contemplating pregnancy, and in patients w/ evidence of ventricular dysfunction (eg, CHF, history of CHF).

WARNINGS/PRECAUTIONS

Sol and caps should not be used interchangeably. Rare cases of serious hepatotoxicity reported, including liver failure and death; d/c if clinical signs/symptoms that are consistent w/ liver disease develop. Caution w/ cardiac disease (eg, ischemic/valvular disease); pulmonary disease (eg, COPD); and renal failure and other edematous disorders. Itraconazole reported to have a negative inotropic effect. CHF, peripheral edema, and pulmonary edema reported. D/C if neuropathy occurs. Consider switching to alternative therapy if a cystic fibrosis patient does not respond to therapy. Transient/permanent hearing loss reported. Absorption of itraconazole may be decreased in HIV-infected individuals who have hypochlorhydria. Caution in hepatic/renal impairment and in the elderly.

ADVERSE REACTIONS

N/V, edema, headache, rash, diarrhea, fatigue, fever, rhinitis, URTI, sinusitis, abdominal pain, dizziness, elevated liver enzymes, HTN, flatulence.

DRUG INTERACTIONS

See Boxed Warning and Contraindications. Not recommended w/ potent CYP3A4 inducers (eg, rifabutin, carbamazepine, efavirenz), tamsulosin, apixaban, rivaroxaban, axitinib, dabrafenib, dasatinib, ibrutinib, nilotinib, sunitinib, simeprevir, aliskiren, sildenafil (for the treatment of pulmonary HTN), everolimus, temsirolimus, salmeterol, darifenacin, vardenafil, conivaptan, and tolvaptan. Avoid CYP3A4 inducers from 2 weeks before and during treatment w/ itraconazole, unless the benefits outweigh the risk of potentially reduced itraconazole efficacy; monitor antifungal activity and increase itraconazole dose as necessary. Drugs that reduce the gastric acidity (eg, aluminum hydroxide, H2-receptor antagonists, proton pump inhibitors) may impair absorption; use w/ caution. Potent CYP3A4 inhibitors (eg, ciprofloxacin, clarithromycin, telaprevir) may increase levels; use w/ caution, monitor closely for signs/symptoms of increased/prolonged itraconazole pharmacologic effects, and decrease itraconazole dose as necessary. Caution w/ alfentanil, buprenorphine (IV and SL), fentanyl, oxycodone, sufentanil, digoxin, coumarins, cilostazol, dabigatran, repaglinide, saxagliptin, praziquantel, eletriptan, bortezomib, busulphan, docetaxel, erlotinib, imatinib, ixabepilone, lapatinib, ponatinib, trimetrexate, vinca alkaloids, alprazolam, aripiprazole, buspirone, diazepam, haloperidol, midazolam IV, perospirone, quetiapine, ramelteon, risperidone, maraviroc, indinavir, ritonavir, saquinavir, nadolol, dihydropyridine calcium channel blockers [except felodipine and nisoldipine], verapamil, bosentan, riociguat, aprepitant, budesonide, ciclesonide, dexamethasone, cyclosporine, fluticasone, methylprednisolone, sirolimus, tacrolimus, atorvastatin, oxybutynin, sildenafil (for the treatment of erectile dysfunction), tadalafil, tolterodine, and cinacalcet. May decrease levels of meloxicam; use w/ caution and monitor effects/side effects; adjust meloxicam dose if necessary. May inhibit metabolism of drugs metabolized by CYP3A4 and can inhibit drug transport by P-gp, which may result in increased plasma concentrations of these drugs and/or their active metabolite(s). Refer to PI for more information on drug interactions.

PREGNANCY AND LACTATION

Category C, caution in nursing.

MECHANISM OF ACTION

Azole antifungal agent; inhibits the CYP450-dependent synthesis of ergosterol, which is a vital component of fungal cell membranes.

PHARMACOKINETICS

Absorption: Rapid. Absolute oral bioavailability (55%); Tmax=2-5 hrs. Distribution: Vd>700L; plasma protein binding (99.8%, itraconazole), (99.6%, hydroxy-metabolite); found in breast milk. Metabolism: Liver (extensive) via CYP3A4; hydroxyitraconazole (major metabolite). Elimination: (IV) Urine (<1% unchanged and hydroxyitraconazole); (PO) feces (3-18% unchanged).

ASSESSMENT

Assess for hypersensitivity to the drug or to other azole antifungal agents, ventricular dysfunction, ischemic/valvular disease, pulmonary disease, renal/hepatic impairment, edematous disorders, or any other conditions where treatment is cautioned or contraindicated. Assess pregnancy/nursing status and for possible drug interactions. Obtain specimens for fungal cultures and other relevant lab studies to isolate and identify causative organisms.

MONITORING

Monitor for signs/symptoms of CHF, peripheral/pulmonary edema, hepatotoxicity, neuropathy, transient/permanent hearing loss, and other adverse reactions. Monitor LFTs.

PATIENT COUNSELING

Instruct not to interchange caps and oral sol. Instruct to take w/ a full meal. Instruct on signs/symptoms of CHF and liver dysfunction; advise to d/c use if these occur and contact physician immediately. Instruct to contact physician before taking any concomitant medications w/ the drug. Instruct to d/c therapy and inform physicians if hearing loss occurs. Instruct that dizziness or blurred/double vision may sometimes occur; advise not to drive or use machines if these events occur.

STORAGE

15-25°C (59-77°F). Protect from light and moisture.

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