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

CONTRAINDICATIONS

  • Drug Interactions

WARNINGS

  • Cardiac Disease

PRECAUTIONS

  • 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)

ADVERSE REACTIONS

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

PATIENT PACKAGE INSERT

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

CONTRAINDICATIONS

  • Drug Interactions
    • nisoldipine

WARNINGS

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