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Label Changes for:

Sporanox (itraconazole) Oral Solution, 10 mg/mL

March 2009

Changes have been made to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- March 2009


The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.

Summary View

Sections Modified


Sections Modified

Summary of Changes to Contraindications and Warnings


  • Drug Interactions


  • Congestive Heart Failure
  • Drug Interactions


  • Cardiac Dysrhythmias
  • Cardiac Disease
  • Treatment of Severely Neutropenic Patients


  • Hearing Loss
    • Transient or permanent hearing loss has been reported .....
  • Information for Patients
    • Instruct patients that hearing loss can occur...
  • Drug Interactions Table additions
    • ...disopyramide..(including nisoldipine)..levacetylmethadol (levomethadyl), ergot alkaloids, halofantrine..budesonide,
      dexamethasone, fluticasone..warfarin, cilostazol, eletriptan, fentanyl...
  • Antiarrhythmics
    • The class IA antiarrhythmic disopyramide has the potential to increase the QT interval...
    • ...via inhibition of P glycoprotein.
  • Calcium Channel Blockers
    • ...due to an increased risk of CHF. Concomitant administration of Sporanox and nisoldipine results in...
  • Other
    • Levacetylmethadol (levomethadyl) is known to prolong the QT...
    • Elevated concentrations of ergot alkaloids can cause ergotism...
    • Halofantrine has the potential to prolong the QT interval...
    • Sporanox may..."glucocorticosteroids such as budesonide, dexamethasone, fluticasone and"...
    • Cilostazol and eletriptan are CYP3A4 metabolized...
    • Fentanyl plasma concentrations could...
  • Pregnancy:Teratogenic Effects, Pregnancy Category C
    • During post-marketing experience, cases of congenital abnormalities have been reported.
  • Geriatric Use (new section)
  • Renal Impairment (new section)
  • Hepatic Impairment (new section)


  • Postmarketing Experience
    • Revised and table updated
      • Transient or permanent hearing loss


  • Drug Interactions
    • Coadministration of "levacetylmethadol (levomethadyl)" addition
    • ..sudden death have occurred in patients using "levacetylmethadol (levomethadyl)"...


  • Congestive Heart Failure (new section)
  • Drug Interactions
    • nisoldipine
    • levacetylmethadol
    • Ergot alkaloids metabolized...


  • Cardiac Dysrhythmias
    • levacetylmethadol (levomethadyl)
  • Cardiac Disease
    • Itraconazole has been shown to have a negative inotropic effect.
    • Sporanox has been associated with reports of congestive heart failure. In post-marketing...
    • Calcium channel blockers can have negative inotropic effects
  • Treatment of Severely Neutropenic Patients (new section)