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Label Changes for:

Sporanox (itraconazole) Injection, 10 mg/mL

March 2009

Changes have been made to the CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT 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


  • Cardiac Disease


  • Hearing Loss
    • Transient or permanent hearing loss has been reported .....
  • Information for Patients
    • Instruct patients that hearing loss can occur...
  • Antiarrhythmics
    • Concomitant administration of digoxin...added "via inhibition of P-glycoprotein"
  • Drug Interactions/Calcium Channel Blockers
    • added...due to an increased risk of CHF. Concomitant administration of Sporanox and nisoldipine results in...
  • Drug Interactions/Other
    • fluticasone
    • Fentanyl plasma concentrations could be increased or prolonged by concomitant use of Sporanox and may cause potentially fatal respiratory depression
  • Geriatric Use
    • Transient or permanent hearing loss has been reported...
  • Renal Impairment (new)
  • Hepatic Impairment (new)


  • Post-marketing Experience (replaced with table)
    • Adverse drug reactions that have been identified during post-approval use of Sporanox (all formulations) are listed ...


  • Who Should Not Take Sporanox and What Are The Possible Side Effects Of Sporanox section


  • Drug Interactions
    • nisoldipine


  • Cardiac Disease
    • Sporanox has been associated with reports of congestive heart failure. In post-marketing...
    • Calcium channel blockers can have negative inotropic effects