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Sporanox (itraconazole) Capsules, 100 mg March 2009

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. Read about the new physician labeling format.

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)