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U.S. Department of Health and Human Services

Safety

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Sporanox (itraconazole) oral solution and capsules

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

 

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

 

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