Cisapride (removed from Market 2000)
- Serious cardiac arrhythmias including ventricular tachycardia, ventricular fibrillaton, torsades de pointes, and QT prolongation.
- Risk factors include concurrent therapy with drugs known to cause QT prolongation, depleted serum electrolytes.
- Contraindicated with numerous drugs including those known to cause QT prolongation (tricyclics, certain antipsychotics) or CYP 450 3A4 inhibitors (fluconazole, ketoconazole, itraconazole).
- See package insert
- Do not exceed recommended doses
Note: This drug was withdrawn from market in 2000 and only available via restricted distribution.
MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA
- Perform 12 ECG lead prior to administration
- Do not initiate therapy if QTc > 450 msec
- Serum electrolytes and creatinine assessed prior to therapy and whenever condition develops that may affect electrolyte balance or renal function.
- If syncope, rapid or irregular heartbeat develops stop drug.
- Drug withdrawn in 2000 and is available only via restricted distribution and registration program
Patient Counseling Information