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A one-month-old male infant received 2 mg/kg of cisapride 4 times per day for 5 days. The patient developed third degree heart block and subsequently died of right ventricular perforation caused by pacemaker wire insertion.
In instances of overdose, patients should be evaluated for possible QT prolongation and ventricular arrhythmias, including torsades de pointes. Treatment should include gastric lavage and/or activated charcoal, close observation and general supportive measures.
Single oral doses of cisapride at 4000 mg/kg, 160 mg/kg, 1280 mg/kg, and 640 mg/kg were lethal in adult rats, neonatal rats, mice, and dogs, respectively. Symptoms of acute toxicity were ptosis, tremors, convulsions, dyspnea, loss of righting reflex, catalepsy, catatonia, hypotonia, and diarrhea.
Serious cardiac arrhythmias including ventricular tachycardia, ventricular fibrillation, torsades de pointes, and QT prolongation have been reported in patients taking cisapride with other drugs that inhibit cytochrome P450 3A4. Some of these events have been fatal.
Concomitant oral or intravenous administration of the following drugs with cisapride may lead to elevated cisapride blood levels and is contraindicated (see WARNINGS, PRECAUTIONS, and DRUG INTERACTIONS).
Antibiotics: Oral or IV erythromycin, clarithromycin (Biaxin), troleandomycin (TAO).
Antidepressants: Nefazodone (Serzone).
Antifungals: Oral or IV fluconazole (Diflucan), itraconazole (Sporanox), oral ketoconazole (Nizoral).
Protease Inhibitors: Indinavir (Crixivan), ritonavir (Norvir).
Cisapride is Also Contraindicated for Patients With: History of prolonged electrocardiographic QT intervals or known family history of congenital long QT syndrome; renal failure; history of ventricular arrhythmias, ischemic heart disease, and congestive heart failure; clinically significant bradycardia; uncorrected electrolyte disorders (hypokalemia, hypomagnesemia); respiratory failure; and concomitant medications known to prolong the QT interval and increase the risk of arrhythmia, such as certain antiarrhythmics, certain antipsychotics, certain antidepressants, astemizole, bepridil, sparfloxacin, and terodiline. The preceding lists of drugs are not comprehensive.
Cisapride should not be used in patients with uncorrected hypokalemia or hypomagnesemia or who might experience rapid reduction of plasma potassium such as those administered potassium-wasting diuretics and/or insulin in acute settings.
Cisapride should not be used in patients in whom an increase in gastrointestinal motility could be harmful, e.g., in the presence of gastrointestinal hemorrhage, mechanical obstruction, or perforation. Cisapride is contraindicated in patients with known sensitivity or intolerance to the drug.
Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.
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