Sporanox (itraconazole) oral solution and capsules
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
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.
- 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.
- 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.
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.
- 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.
- ..., felodipine, methadone and ….are contraindicated with Sporanox.
- Life-threatening cardiac dysrhythmias and/or sudden death have occurred in patients using methadone…..
- 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.
- dyspnea and acute generalized exanthematous pustulosis (AGEP)
- Gastrointestinal disorders: Pancreatitis
PATIENT PACKAGE INSERT
WHAT ARE THE POSSIBLE SIDE EFFECTS OF SPORANOX
- Call your doctor right away..fever, inflammation of the pancreas