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U.S. Department of Health and Human Services

Safety

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Sporanox (Itraconazole) Capsules

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – April 2012

Summary View

 

BOXED WARNING

  • Cardiac Effects and Drug Interactions:…
  • Drug interactions: Oral Midazolam, Nisoladipine, Felodipine…Triazolam…Lovastatin, Simvastatin, Ergot Alkaloids such as Dihydroergotamine, Ergometrine (Ergonovine), Ergotamine and Methylergometrine (Methylergonovine) or Methadone…
 

CONTRAINDICATIONS

  • and Clinical Pharmacology, Special Populations.
Drug Interactions:
  • Felodipine…Methadone
 

WARNINGS:

Cardiac Dysrhythmias:
  • Methadone…
 

PRECAUTIONS

Drug Interactions:
Table 1
  • Calcium Channel Blockers – felodipine…
  • Other – Methadone…
Calcium Channel blockers:
  • Nisoldipine…
  • 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…
Other:
  • Methadone and…
  • …Methadone or…
 

PATIENT INFORMATION

Never take Sporanox if you:
Are taking any of the medicines listed below. Dangerous or even life-threatening abnormal heartbeats could result:
  • Methadone (such as Dolophine)
  • Felodipine (such as Plendil)

 

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