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Itraconazole (Capsules, Oral Solution)

Congestive Heart Failure and Cardiac Interactions

  • Should not be administered for the treatment of onychomycosis in patients with evidence of ventricular dysfunction such as congestive heart failure (CHF) or a history of CHF.
  • When itraconazole was administered intravenously to dogs and healthy human volunteers, negative inotropic effects were seen.
  • If signs or symptoms of congestive heart failure occur during administration of itraconazole, discontinue administration. (See CLINICAL PHARMACOLOGY, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS: Drug Interactions and ADVERSE REACTIONS).

 Contraindicated Drug Interactions

  • Coadministration of the following drugs are contraindicated with itraconazole: methadone, disopyramide, dofetilide, dronedarone, quinidine, ergot alkaloids (such as dihydroergotamine, ergometrine (ergonovine), ergotamine, methylergometrine (methylergonovine)), irinotecan, lurasidone, oral midazolam, pimozide, triazolam, felodipine, nisoldipine, ranolazine, eplerenone, cisapride, lovastatin, simvastatin and, in subjects with renal or hepatic impairment, colchicine. Coadministration with itraconazole can cause elevated plasma concentrations of these drugs and may increase or prolong both the pharmacologic effects and/or adverse reactions to these drugs. For example, increased plasma concentrations of some of these drugs can lead to QT prolongation and ventricular tachyarrhythmias including occurrences of torsades de pointes, a potentially fatal arrhythmia.(See CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS: Drug Interactions for more information).
  • CYP3A4 inhibitors (including itraconazole) may increase systemic contraceptive hormone concentrations.

Immunocompromised Patients

  • In some immunocompromised patients (e.g., neutropenic, AIDS or organ transplant patients), the oral bioavailability of Itraconazole capsules may be decreased. Therefore, the dose should be adjusted based on the clinical response in these patients.

MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA

  • Monitor for signs and symptoms of CHF, discontinue if these develop.
  • Obtain nail specimens for laboratory testing prior to prescribing the medications for onychomycosis to confirm the diagnosis.

Patient Counseling Information

SPORANOX

TOLSURA

Package Inserts

Itraconazole

Additional Information

Updated March 2019