Safety

Sporanox (itraconazole) oral solution and capsules

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

April 2015

Summary View

BOXED WARNING

Congestive Heart Failure, Cardiac Effects and Drug Interactions
  • Coadministration of the following drugs are contraindicated with SPORANOX Capsules… ticagrelor and, in subjects with varying degrees of renal or hepatic impairment, colchicine, fesoteridine, telithromycin and solifenacin. See PRECAUTIONS: Drug Interactions Section for specific examples.

CONTRAINDICATIONS

Drug Interactions
  • Coadministration of a number of CYP3A4 substrates are contraindicated with SPORANOX
  • Plasma concentrations increase for the following drugs: …ticagrelor, and, in subjects with varying degrees of renal or hepatic impairment, colchicine, fesoterodine, telithromycin and solifenacin.

PRECAUTIONS

Cystic Fibrosis
  • If a cystic fibrosis patient does not respond to SPORANOX  Capsules, consideration should be given to switching to alternative therapy. For more information concerning the use of itraconazole in cystic fibrosis patients see the prescribing information for SPORANOX Oral Solution.
Drug Interactions

Drugs that may have their plasma concentrations increased by itraconazole

  • ticagrelor, and, in subjects with varying degrees of renal or hepatic impairment, colchicine, fesoterodine, telithromycin and solifenacin.

ADVERSE REACTIONS

Post-Marketing Experience
  • tremor

 

March 2012

Summary View

BOXED WARNING

Drug Interactions
  • Coadministration of ... oral midazolam, nisoldipine, felodipine, triazolam, lovastatin, simvastatin, ergot alkaloids such as dihydroergotamine, ergometrine (ergonovine), ergotamine and methylergometrine (methylergonovine) or methadone with Sporanox (itraconazole) Capsules or Oral Solution is contraindicated.

CONTRAINDICATIONS

Drug Interactions
  • ..., felodipine, methadone and ….are contraindicated with Sporanox.

WARNINGS

Cardiac Dysrhythmias
  • Life-threatening cardiac dysrhythmias and/or sudden death have occurred in patients using methadone…..

PRECAUTIONS

Drug Interactions
  • Calcium Channel Blockers: ...A clinical study showed that felodipine exposure was increased by coadministration of itraconazole, resulting in approximately a 6-fold increase in the AUC and an 8-fold increase in the Cmax. The concomitant use of sporanox and felodipine is contraindicated.

ADVERSE REACTIONS

Postmarketing Experience
  • dyspnea and acute generalized exanthematous pustulosis (AGEP)   

 

July 2010

Summary View 

ADVERSE REACTIONS

Post-marketing experience
  • Gastrointestinal disorders: Pancreatitis 

PATIENT PACKAGE INSERT

WHAT ARE THE POSSIBLE SIDE EFFECTS OF SPORANOX
  • Call your doctor right away..fever, inflammation of the pancreas 

 

Page Last Updated: 05/13/2015
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