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Cisapride (United States: Available via limited access/FDA investigational drug [IND] protocol only): Drug information

Cisapride (United States: Available via limited access/FDA investigational drug [IND] protocol only): Drug information
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For additional information see "Cisapride (United States: Available via limited access/FDA investigational drug [IND] protocol only): Patient drug information" and "Cisapride (United States: Available via limited access/FDA investigational drug [IND] protocol only): Pediatric drug information"

For abbreviations, symbols, and age group definitions show table
ALERT: US Boxed Warning
Arrhythmias:

Serious cardiac arrhythmias including ventricular tachycardia, ventricular fibrillation, torsades de pointes, and QT prolongation have been reported in patients taking cisapride. From July 1993 through May 1999, more than 270 such cases have been spontaneously reported, including 70 fatalities. In approximately 85% of these cases the events occurred when cisapride was used in patients with known risk factors. These risk factors included the administration of other drugs which caused QT prolongation, inhibited the cytochrome P450 3A4 enzymes that metabolize cisapride, or depleted serum electrolytes; or the presence of disorders that may have predisposed patients to arrhythmias. In approximately 0.7% of these cases, the events occurred in the absence of identified risk factors; in the remaining cases, risk factor status was unknown. Because the cases were reported voluntarily from a population of unknown size, estimates of adverse event frequency cannot be made.

Numerous drug classes and agents increase the risk of developing serious cardiac arrhythmias. Cisapride is contraindicated in patients taking certain macrolide antibiotics (such as clarithromycin, erythromycin, and troleandromycin), certain antifungals (such as fluconazole, itraconazole, and ketoconazole), protease inhibitors (such as indinavir and ritonavir), phenothiazines (such as prochlorperazine and promethazine), Class IA and Class III antiarrhythmics (such as quinidine, procainamide, and sotalol); tricyclic antidepressants (such as amitriptyline); certain antidepressants (such as nefazodone and maprotiline); certain antipsychotic medications (such as sertindole), as well as other agents (such as bepridil, sparfloxacin, and grapefruit juice). The preceding list is not comprehensive.

QT prolongation, torsades de pointes (sometimes with syncope), cardiac arrest and sudden death have been reported in patients taking cisapride without the above-mentioned contraindicated drugs. Most patients had disorders that may have predisposed them to arrhythmias with cisapride. These include history of prolonged electrocardiographic QT intervals or known family histroy of congenital long QT syndrome; history of ventricular arrhythmias, ischemic or valvular heart disease; other structural heart defects; cardiomyopathy; congestive heart failure; clinically significant bradycardia; sinus node dysfunction; second or third degree atrioventricular block; respiratory failure; or conditions that result in electrolyte disorders (hypokalemia, hypocalcemia, and hypomagnesemia), such as severe dehydration, vomiting, or malnutrition; eating disorders; renal failure; or the administration of potassium-wasting diuretics or insulin in acute settings. Cisapride is contraindicated in patients with these conditions.

A 12-lead ECG should be performed prior to administration of cisapride. Treatment with cisapride should not be initiated if the QTc value exceeds 450 milliseconds. Serum electolytes (potassium, calcium and magnesium) and creatinine should be assessed prior to administration of cisapride and whenever conditions develop that may affect electrolyte balance or renal function.

If syncope, rapid or irregular heartbeat develop, patients should immediately stop taking cisapride and seek the attention of a physician.

Recommended doses of cisapride should not be exceeded.

Brand Names: US
  • Propulsid®
Pharmacologic Category
  • Gastrointestinal Agent, Prokinetic
Dosing: Adult
Gastroesophageal reflux disease/GI dysmotility

Gastroesophageal reflux disease/GI dysmotility: Oral: Initial: 5-10 mg 4 times/day at least 15 minutes before meals and at bedtime; in some patients the dosage will need to be increased to 20 mg to obtain a satisfactory result.

Dosing: Kidney Impairment: Adult

No dosage adjustment provided in manufacturer’s labeling; use with caution.

Dosing: Liver Impairment: Adult

Initiate at 50% usual dose.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Cisapride (United States: Available via limited access/FDA investigational drug [IND] protocol only): Pediatric drug information")

Gastroesophageal reflux disease/GI dysmotility

Gastroesophageal reflux disease/GI dysmotility: Limited data available: Infants, Children, and Adolescents: Oral: 0.15 to 0.2 mg/kg/dose 3 to 4 times/day; maximum dose: 10 mg/dose. Note: Doses up to 0.3 mg/kg/dose every 8 hours have been described; however, due to safety concerns, most experts recommend a maximum dose of 0.8 mg/kg/day in divided doses (Ref).

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in manufacturer’s labeling; use with caution.

Dosing: Liver Impairment: Pediatric

There are no specific recommendations in pediatric patients; based on experience in adult patients, dosage adjustment suggested.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:

Gastrointestinal: Diarrhea

Nervous system: Headache

1% to 10%:

Gastrointestinal: Abdominal pain, constipation, dyspepsia, flatulence

Genitourinary: Urinary frequency, vaginitis

Infection: Viral infection

Nervous system: Insomnia, nervousness, pain

Ophthalmic: Visual disturbance

Respiratory: Cough, rhinitis

<1%:

Cardiovascular: Edema, palpitations

Gastrointestinal: Xerostomia

Nervous system: Drowsiness, migraine, tremor

Postmarketing:

Cardiovascular: Cardiac arrhythmia, prolonged QT interval on ECG, sinus tachycardia, tachycardia, torsades de pointes, ventricular fibrillation, ventricular tachycardia

Endocrine & metabolic: Galactorrhea not associated with childbirth, gynecomastia, hyperprolactinemia

Genitourinary: Breast hypertrophy (females), urinary incontinence

Hematologic & oncologic: Aplastic anemia, granulocytopenia, leukopenia, pancytopenia, thrombocytopenia

Hepatic: Hepatitis, increased liver enzymes

Hypersensitivity: Angioedema, hypersensitivity reaction

Nervous system: Depression, extrapyramidal reaction (including akathisia, dyskinesia, dystonia, parkinsonism), psychiatric disturbance (including confusion, hallucination, suicidal tendencies), seizure

Contraindications

Hypersensitivity to cisapride or any component of the formulations; GI hemorrhage, mechanical obstruction, GI perforation, or other situations when GI motility stimulation is dangerous

Serious cardiac arrhythmias including ventricular tachycardia, ventricular fibrillation, torsade de pointes, and QT prolongation have been reported in patients taking cisapride with other drugs that inhibit CYP3A4. 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:

Antibiotics: Oral or IV erythromycin, clarithromycin, troleandomycin

Antidepressants: Nefazodone

Antifungals: Oral or IV fluconazole, itraconazole, miconazole, oral ketoconazole

Protease inhibitors: Indinavir, ritonavir, amprenavir, atazanavir

Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Cisapride is also contraindicated for patients with a prolonged electrocardiographic QT intervals (QTc >450 msec), a history of QTc prolongation, or known family history of congenital long QT syndrome; clinically significant bradycardia, renal failure, history of ventricular arrhythmias, ischemic heart disease, and congestive heart failure; 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, 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.

Warnings/Precautions

Special note:

On March 24, 2000, the FDA announced that the manufacturer of cisapride would voluntarily withdraw its product from the U.S. market on July 14, 2000. This decision was based on 341 reports of heart rhythm abnormalities including 80 reports of deaths. The company will continue to make the drug available to patients who meet specific clinical eligibility criteria for a limited-access protocol (contact 1-800-JANSSEN).

Concerns related to adverse effects:

• Arrhythmias: [U.S. Boxed Warning]: Serious cardiac arrhythmias including ventricular tachycardia, ventricular fibrillation, torsade de pointes, and QT prolongation have been reported in patients taking this drug. Many of these patients also took drugs expected to increase cisapride blood levels by inhibiting the cytochrome P450 3A4 enzymes that metabolize cisapride. These drugs include clarithromycin, erythromycin, troleandomycin, nefazodone, fluconazole, itraconazole, ketoconazole, indinavir and ritonavir. Some of these events have been fatal. Cisapride is contraindicated in patients taking any of these drugs. QT prolongation, torsade de pointes (sometimes with syncope), cardiac arrest and sudden death have been reported in patients taking cisapride without the above-mentioned contraindicated drugs. Most patients had disorders that may have predisposed them to arrhythmias with cisapride. Cisapride is contraindicated for those patients with: history of prolonged electrocardiographic QT intervals; renal failure; history of ventricular arrhythmias, ischemic heart disease, and HF; 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, including those of Class Ia (such as quinidine and procainamide) and Class III (such as sotalol); tricyclic antidepressants (such as amitriptyline); certain tetracyclic antidepressants (such as maprotiline); certain antipsychotic medications (such as certain phenothiazines and sertindole), protease inhibitors, bepridil, sparfloxacin and terodiline. (The preceding lists of drugs are not comprehensive.) Recommended doses of cisapride should not be exceeded.

Disease-related concerns:

• Electrolyte disturbances: Should not be used in patients with uncorrected hypokalemia or hypomagnesemia, such as those with severe dehydration, vomiting or malnutrition, or those taking potassium-wasting diuretics; should also not be used in patients who might experience rapid reduction of plasma potassium, such as those administered potassium-wasting diuretics and/or insulin in acute settings.

Other warnings/precautions:

• Risk vs. benefit: Potential benefits should be weighed against risks prior administration of cisapride to patients who have or may develop prolongation of cardiac conduction intervals, particularly QTc. These include patients with conditions that could predispose them to the development of serious arrhythmias, such as multiple organ failure, COPD, apnea and advanced cancer. Patients should have a baseline ECG and an electrolyte panel (magnesium, calcium, potassium) prior to initiating cisapride (see Contraindications).

Generic Equivalent Available: US

No

Prescribing and Access Restrictions

In U.S., available via limited-access protocol only. Call 877-795-4247 for more information.

Administration: Pediatric

Oral: Administer ≥15 minutes before meals or feeding

Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and at http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088994.pdf, must be dispensed with this medication.

Use: Labeled Indications

Treatment of nocturnal symptoms of gastroesophageal reflux disease (GERD); has demonstrated effectiveness for gastroparesis, refractory constipation, and nonulcer dyspepsia

Medication Safety Issues
Sound-alike/look-alike issues:

Propulsid® may be confused with propranolol

Metabolism/Transport Effects

Substrate of CYP1A2 (Minor), CYP2A6 (Minor), CYP2B6 (Minor), CYP2C19 (Minor), CYP2C9 (Minor), CYP3A4 (Major with inhibitors), CYP3A4 (Minor with inducers); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential;

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Agents with Clinically Relevant Anticholinergic Effects: May decrease therapeutic effects of Gastrointestinal Agents (Prokinetic). Risk C: Monitor

Alcohol (Ethyl): Cisapride may increase adverse/toxic effects of Alcohol (Ethyl). Specifically, Alcohol (Ethyl) sedative and psychomotor effects may be enhanced. Alcohol (Ethyl) may also worsen nocturnal heartburn. Cisapride may increase serum concentration of Alcohol (Ethyl). Risk C: Monitor

Amiodarone: QT-prolonging Miscellaneous Agents (Highest Risk) may increase QTc-prolonging effects of Amiodarone. Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Amisulpride (Oral): QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Amisulpride (Oral). Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even greater risk. Risk D: Consider Therapy Modification

Amitriptyline: May increase arrhythmogenic effects of Cisapride. Risk X: Avoid

Arsenic Trioxide: QT-prolonging Miscellaneous Agents (Highest Risk) may increase QTc-prolonging effects of Arsenic Trioxide. Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Azithromycin (Systemic): QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Azithromycin (Systemic). Management: Consider alternatives to this combination. Patients with other risk factors (eg, older age, female sex, bradycardia, hypokalemia, hypomagnesemia, heart disease, and higher drug concentrations) are likely at greater risk for these toxicities. Risk D: Consider Therapy Modification

Bedaquiline: QT-prolonging Miscellaneous Agents (Highest Risk) may increase QTc-prolonging effects of Bedaquiline. Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Carbetocin: May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Chloroquine: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Chloroquine. Management: Consider alternatives to this combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

ChlorproMAZINE: QT-prolonging Miscellaneous Agents (Highest Risk) may increase QTc-prolonging effects of ChlorproMAZINE. Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Cimetidine: May increase serum concentration of Cisapride. Management: Consider alternatives to cimetidine. If this combination cannot be avoided, monitor for toxic effects of cisapride, particularly QTc interval prolongation. Risk D: Consider Therapy Modification

Citalopram: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Citalopram. Risk X: Avoid

Clarithromycin: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Clarithromycin. Risk X: Avoid

Clofazimine: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Clofazimine. Management: Consider alternatives to this combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

ClomiPRAMINE: May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Clotiazepam: Cisapride may increase absorption of Clotiazepam. Risk C: Monitor

CloZAPine: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of CloZAPine. Management: Consider alternatives to this combination. Patients with other risk factors (eg, older age, female sex, bradycardia, hypokalemia, hypomagnesemia, heart disease, and higher drug concentrations) are likely at greater risk for these toxicities. Risk D: Consider Therapy Modification

CYP3A4 Inhibitors (Moderate): May increase serum concentration of Cisapride. Management: Consider alternatives to this combination. Prescribing information for some moderate CYP3A4 inhibitors state coadministration with cisapride is contraindicated, while some others recommend monitoring and dose titration. Risk D: Consider Therapy Modification

CYP3A4 Inhibitors (Strong): May increase serum concentration of Cisapride. Risk X: Avoid

Dabrafenib: May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Dasatinib: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Dasatinib. Management: Consider alternatives to this combination. Patients with other risk factors (eg, older age, female sex, bradycardia, hypokalemia, hypomagnesemia, heart disease, and higher drug concentrations) are likely at greater risk for these toxicities. Risk D: Consider Therapy Modification

Domperidone: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Domperidone. Risk X: Avoid

Doxepin-Containing Products: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Doxepin-Containing Products. Management: Consider alternatives to this combination. Patients with other risk factors (eg, older age, female sex, bradycardia, hypokalemia, hypomagnesemia, heart disease, and higher drug concentrations) are likely at greater risk for these toxicities. Risk D: Consider Therapy Modification

Dronedarone: QT-prolonging Miscellaneous Agents (Highest Risk) may increase QTc-prolonging effects of Dronedarone. Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

DroPERidol: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of DroPERidol. Management: Consider alternatives to this combination. Patients with other risk factors (eg, older age, female sex, bradycardia, hypokalemia, hypomagnesemia, heart disease, and higher drug concentrations) are likely at greater risk for these toxicities. Risk D: Consider Therapy Modification

Encorafenib: May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Entrectinib: May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Risk X: Avoid

Erythromycin (Systemic): Cisapride may increase QTc-prolonging effects of Erythromycin (Systemic). Erythromycin (Systemic) may increase QTc-prolonging effects of Cisapride. Erythromycin (Systemic) may increase serum concentration of Cisapride. Risk X: Avoid

Escitalopram: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Escitalopram. Management: Consider alternatives to this combination. Patients with other risk factors (eg, older age, female sex, bradycardia, hypokalemia, hypomagnesemia, heart disease, and higher drug concentrations) are likely at greater risk for these toxicities. Risk D: Consider Therapy Modification

Etelcalcetide: May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Fexinidazole: May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Risk X: Avoid

Fingolimod: May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias (including TdP) with a continuous overnight ECG when fingolimod is combined with QT prolonging drugs. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

Flecainide: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Flecainide. Management: Consider alternatives to this combination. Patients with other risk factors (eg, older age, female sex, bradycardia, hypokalemia, hypomagnesemia, heart disease, and higher drug concentrations) are likely at greater risk for these toxicities. Risk D: Consider Therapy Modification

Fluconazole: May increase QTc-prolonging effects of Cisapride. Fluconazole may increase serum concentration of Cisapride. Risk X: Avoid

Fluorouracil Products: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Fluorouracil Products. Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Flupentixol: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Flupentixol. Risk X: Avoid

FluvoxaMINE: May increase serum concentration of Cisapride. Management: Avoid this combination when possible. The combination is specifically contraindicated in at least some non-US labeling. Risk X: Avoid

Fosamprenavir: May increase serum concentration of Cisapride. Risk X: Avoid

Fosfomycin: Gastrointestinal Agents (Prokinetic) may decrease serum concentration of Fosfomycin. Risk C: Monitor

Fusidic Acid (Systemic): May increase serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Consider avoiding this combination if possible. If required, monitor patients closely for increased adverse effects of the CYP3A4 substrate. Risk D: Consider Therapy Modification

Gadobenate Dimeglumine: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Gadobenate Dimeglumine. Management: Consider alternatives to this combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Gemifloxacin: May increase QTc-prolonging effects of QT-prolonging Miscellaneous Agents (Highest Risk). Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Gilteritinib: May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Consider alternatives to this combination. If use is necessary, monitor for QTc interval prolongation and arrhythmias. Risk D: Consider Therapy Modification

Grapefruit Juice: May increase serum concentration of Cisapride. Risk X: Avoid

Halofantrine: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Halofantrine. Management: Consider alternatives to this combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Haloperidol: QT-prolonging Miscellaneous Agents (Highest Risk) may increase QTc-prolonging effects of Haloperidol. Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

HydrOXYzine: May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Risk C: Monitor

Imipramine: May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Inotuzumab Ozogamicin: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Inotuzumab Ozogamicin. Management: Consider alternatives to this combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Itraconazole: May increase serum concentration of Cisapride. Risk X: Avoid

Lefamulin: May increase QTc-prolonging effects of QT-prolonging CYP3A4 Substrates. Management: Do not use lefamulin tablets with QT-prolonging CYP3A4 substrates. Lefamulin prescribing information lists this combination as contraindicated. Risk X: Avoid

Levofloxacin-Containing Products (Systemic): May increase QTc-prolonging effects of QT-prolonging Miscellaneous Agents (Highest Risk). Management: Consider alternatives to this combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Levoketoconazole: QT-prolonging CYP3A4 Substrates may increase QTc-prolonging effects of Levoketoconazole. Levoketoconazole may increase serum concentration of QT-prolonging CYP3A4 Substrates. Risk X: Avoid

Levosulpiride: Benzamide Derivatives may increase adverse/toxic effects of Levosulpiride. Risk C: Monitor

Lofexidine: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Lofexidine. Management: Consider alternatives to this combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Loprazolam: Cisapride may increase therapeutic effects of Loprazolam. Risk X: Avoid

Meglumine Antimoniate: May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Methadone: May increase QTc-prolonging effects of QT-prolonging Miscellaneous Agents (Highest Risk). Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Midostaurin: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Midostaurin. Management: Consider alternatives to this combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Moxifloxacin (Systemic): QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Moxifloxacin (Systemic). Risk X: Avoid

Nilotinib: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Nilotinib. Risk X: Avoid

OLANZapine: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of OLANZapine. Management: Consider alternatives to this combination. Patients with other risk factors (eg, older age, female sex, bradycardia, hypokalemia, hypomagnesemia, heart disease, and higher drug concentrations) are likely at greater risk for these toxicities. Risk D: Consider Therapy Modification

Ondansetron: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Ondansetron. Management: Consider alternatives to this combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Opioid Agonists: May decrease therapeutic effects of Gastrointestinal Agents (Prokinetic). Risk C: Monitor

Osimertinib: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Osimertinib. Management: Consider alternatives to this combination. Patients with other risk factors (eg, older age, female sex, bradycardia, hypokalemia, hypomagnesemia, heart disease, and higher drug concentrations) are likely at greater risk for these toxicities. Risk D: Consider Therapy Modification

Oxytocin: May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Pacritinib: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Pacritinib. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

PAZOPanib: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of PAZOPanib. Risk X: Avoid

Pentamidine (Systemic): QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Pentamidine (Systemic). Management: Consider alternatives to this combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Pilsicainide: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Pilsicainide. Management: Consider alternatives to this combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Pimozide: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Pimozide. Management: Consider alternatives to this combination. Patients with other risk factors (eg, older age, female sex, bradycardia, hypokalemia, hypomagnesemia, heart disease, and higher drug concentrations) are likely at greater risk for these toxicities. Risk X: Avoid

Piperaquine: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Piperaquine. Risk X: Avoid

Posaconazole: May increase serum concentration of QT-prolonging CYP3A4 Substrates. Such increases may lead to a greater risk for proarrhythmic effects and other similar toxicities. Risk X: Avoid

Probucol: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Probucol. Risk X: Avoid

Propafenone: May increase QTc-prolonging effects of QT-prolonging Miscellaneous Agents (Highest Risk). Management: Consider alternatives to this combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Propofol: May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Protriptyline: May increase arrhythmogenic effects of Cisapride. Risk X: Avoid

QT-prolonging Agents (Indeterminate Risk - Avoid): May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

QT-prolonging Agents (Indeterminate Risk - Caution): May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

QT-prolonging Class IA Antiarrhythmics (Highest Risk): May increase QTc-prolonging effects of QT-prolonging Miscellaneous Agents (Highest Risk). Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

QT-prolonging Class III Antiarrhythmics (Highest Risk): May increase QTc-prolonging effects of QT-prolonging Miscellaneous Agents (Highest Risk). Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

QT-Prolonging Inhalational Anesthetics (Moderate Risk): May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

QT-prolonging Kinase Inhibitors (Highest Risk): May increase QTc-prolonging effects of QT-prolonging Miscellaneous Agents (Highest Risk). Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

QT-prolonging Miscellaneous Agents (Highest Risk): May increase QTc-prolonging effects of Cisapride. Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

QT-prolonging Moderate CYP3A4 Inhibitors (Moderate Risk): May increase QTc-prolonging effects of QT-prolonging Miscellaneous Agents (Highest Risk). Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

QT-prolonging Strong CYP3A4 Inhibitors (Highest Risk): May increase QTc-prolonging effects of Cisapride. QT-prolonging Strong CYP3A4 Inhibitors (Highest Risk) may increase serum concentration of Cisapride. Risk X: Avoid

QT-prolonging Strong CYP3A4 Inhibitors (Moderate Risk): May increase QTc-prolonging effects of Cisapride. QT-prolonging Strong CYP3A4 Inhibitors (Moderate Risk) may increase serum concentration of Cisapride. Risk X: Avoid

QUEtiapine: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of QUEtiapine. Risk X: Avoid

Quinupristin and Dalfopristin: May increase serum concentration of Cisapride. Risk X: Avoid

Quizartinib: May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Consider alternatives to this combination. Patients with other risk factors (eg, older age, female sex, bradycardia, hypokalemia, hypomagnesemia, heart disease, and higher drug concentrations) are likely at greater risk for these toxicities. Risk D: Consider Therapy Modification

Ribociclib: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Ribociclib. Risk X: Avoid

RisperiDONE: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of RisperiDONE. QT-prolonging Agents (Highest Risk) may increase CNS depressant effects of RisperiDONE. Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Roxithromycin: May increase QTc-prolonging effects of Cisapride. Roxithromycin may increase serum concentration of Cisapride. Risk X: Avoid

Sertindole: May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Risk X: Avoid

Simeprevir: May increase serum concentration of Cisapride. Risk X: Avoid

Sincalide: Drugs that Affect Gallbladder Function may decrease therapeutic effects of Sincalide. Management: Consider discontinuing drugs that may affect gallbladder motility prior to the use of sincalide to stimulate gallbladder contraction. Risk D: Consider Therapy Modification

Sirolimus (Conventional): Gastrointestinal Agents (Prokinetic) may increase serum concentration of Sirolimus (Conventional). Risk C: Monitor

Sparfloxacin: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Sparfloxacin. Risk X: Avoid

SUNItinib: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of SUNItinib. Management: Consider alternatives to this combination. Patients with other risk factors (eg, older age, female sex, bradycardia, hypokalemia, hypomagnesemia, heart disease, and higher drug concentrations) are likely at greater risk for these toxicities. Risk D: Consider Therapy Modification

Terbutaline: May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Consider alternatives to this combination. Patients with other risk factors (eg, older age, female sex, bradycardia, hypokalemia, hypomagnesemia, heart disease, and higher drug concentrations) are likely at greater risk for these toxicities. Risk D: Consider Therapy Modification

Thioridazine: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Thioridazine. Risk X: Avoid

Tipranavir: May increase serum concentration of Cisapride. Risk X: Avoid

Toremifene: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Toremifene. Management: Consider alternatives to this combination. Patients with other risk factors (eg, older age, female sex, bradycardia, hypokalemia, hypomagnesemia, heart disease, and higher drug concentrations) are likely at greater risk for these toxicities. Risk D: Consider Therapy Modification

Vemurafenib: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Vemurafenib. Management: Consider alternatives to this combination. Patients with other risk factors (eg, older age, female sex, bradycardia, hypokalemia, hypomagnesemia, heart disease, and higher drug concentrations) are likely at greater risk for these toxicities. Risk D: Consider Therapy Modification

Food Interactions

Coadministration of grapefruit juice with cisapride increases the bioavailability of cisapride. Management: Minimize consumption of grapefruit/grapefruit juice during cisapride therapy; monitor closely for toxic effects (eg, QT interval prolongation, ventricular arrhythmia).

Pregnancy Considerations

Adverse events were observed in animal reproduction studies.

Breastfeeding Considerations

Cisapride is excreted into breast milk. The manufacturer recommends caution be used if administered to a nursing woman.

Monitoring Parameters

A 12-lead ECG should be performed prior to administration of cisapride. Treatment with cisapride should not be initiated if the QTc value exceeds 450 milliseconds. Serum electrolytes (potassium, calcium, and magnesium) and creatinine should be assessed prior to administration of cisapride and whenever conditions develop that may affect electrolyte balance or renal function.

Mechanism of Action

Enhances the release of acetylcholine at the myenteric plexus. In vitro studies have shown cisapride to have serotonin-4 receptor agonistic properties which may increase gastrointestinal motility and cardiac rate; increases lower esophageal sphincter pressure and lower esophageal peristalsis; accelerates gastric emptying of both liquids and solids.

Pharmacokinetics (Adult Data Unless Noted)

Onset of action: 0.5-1 hour

Protein binding: 97.5% to 98%

Metabolism: Extensive in liver via cytochrome P450 isoenzyme CYP 3A3/4 to norcisapride

Bioavailability: 35% to 40%

Half-life elimination: 6-12 hours

Excretion: Urine and feces (<10%)

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Prepulsid | Prokinate;
  • (AR) Argentina: Cinacol | Cisap | Cisapride ilab | Cispride | Digenormotil | Etacril | Fabrapride | Kinetizine | Prepulsid | Pulsar | Pulsar pediatrico | Pulsar reflux | Regalisa;
  • (AT) Austria: Prepulsid;
  • (AU) Australia: Prepulsid;
  • (BD) Bangladesh: Apulcid | Ciped | Cipride | Cisarid | Cisid | Gastonom | Isopride | Mopride | Pepmotil;
  • (BE) Belgium: Cyprid | Prepulsid;
  • (BG) Bulgaria: Coordinax;
  • (BR) Brazil: Cinetic | Cisapan | Cisatec | Cispride | Enteropride | Prepulsid;
  • (CH) Switzerland: Prepulsid;
  • (CL) Chile: Cisaprida | Gastrokin | Gastromet | Marovil | Ondax | Prepulsid | Properistal | Tono Cis;
  • (CN) China: Prepulsid | Unipride | Wei fu lai | Yirui;
  • (CO) Colombia: Adirpasic | Calmax | Cipramax | Cisaprida | Cisapride mk | Cisapron | Gastrenol | Kaudalit | Peristalt | Prepulsid | Procinet | Saprid | Sedolax | Zypanar;
  • (CZ) Czech Republic: Prepulsid;
  • (DE) Germany: Prepulsid;
  • (DO) Dominican Republic: Adamin | Cinacol | Cisaprida | Cisapron | Cymapride | Fisiogastrol | Hebacpyl | Kinestase | Lusapride | Motifar | Ondax | Prepulsid | Pridac | Procinet | Sedolax | Suipride | Unamol | Viprasen;
  • (EC) Ecuador: Cisaprida | Cisapron | Gastromet | Ondax | Prepulsid | Tonocis | Viprasen;
  • (EE) Estonia: Coordinax;
  • (EG) Egypt: Cisil | Motiprid | Prepulsid;
  • (ES) Spain: Cisaprida merck | Fisiogastrol | Prepulsid | Trautil;
  • (FI) Finland: Prepulsid;
  • (FR) France: Cisapride Dci | Prepulsid;
  • (GB) United Kingdom: Prepulsid;
  • (GR) Greece: Bozaktral | Cefanyl | Cevilor | Dolyzinax | Elpegon | Epasan | Kinussen | Lamafer | Lirebin | Lycalin | Minsk | Nastilox | Oferin | Ruvetine | Spabucol | Systilan;
  • (HK) Hong Kong: Prepulsid;
  • (ID) Indonesia: Acpulsif | Bellaprid | Colinorm | Disflux | Dispep | Ethiprid | Guarposid | Laprid | Precis | Prepulsid | Presid | Pridesia | Pronetic | Rapulid | Stimulit | Vomiflux | Vomiprid;
  • (IE) Ireland: Prepulsid;
  • (IL) Israel: Prepulsid;
  • (IN) India: Alipride | Alzide | Benz | Cenz | Cide | Ciloid | Cisade | Cisakem | Cisalone | Cisanorm | Cisapid | Cisapro | Cisatec | Cisawal | Cispel | Ciza | Cizafast | Esorid | Gaskin | Gastro | Gastron | Gastropen | Lisa | Mogit | Moten | Moticare | Motilax | Normagut | Normocis | Normokine | Normopel | Nupride | Peristil | Prepulsid | Procisa | Progit | Prokine | Santiza | Syspride | Unipride;
  • (IT) Italy: Prepulsid;
  • (JO) Jordan: Prepulsid | Refluxin | Sepride;
  • (JP) Japan: Acenalin | Risamol;
  • (KR) Korea, Republic of: Cisaconcide | Cisaple | Cisaplus | Cisapren | Mobid | Prepulsid;
  • (KW) Kuwait: Prepulsid;
  • (LB) Lebanon: Ciprid | Prepulsid | Trautil;
  • (LT) Lithuania: Coordinax | Prepulsid;
  • (LU) Luxembourg: Cyprid | Prepulsid;
  • (LV) Latvia: Cipril | Coordinax | Prepulsid | Propulsin;
  • (MA) Morocco: Prepulsid;
  • (MX) Mexico: Aposada | Cepriser | Cisaprida | Cisaprida gi | Cisaprida gi kendr | Cisaprida gi kener | Cisaprida gi serra | Cisaprida iqfa | Cisaprida Senosiain | Enteropride | Eriken | Expril | Kinestase | Lornakin | Mavisid | Nodrix | Prepulsid | Presistin | Prixin | Sapriken | Tadasil | Tezadim | Unamol;
  • (MY) Malaysia: Prepulsid;
  • (NL) Netherlands: Prepulsid;
  • (NO) Norway: Gasprid | Prepulsid;
  • (NZ) New Zealand: Prepulsid;
  • (PE) Peru: Cisamod | Cisaprida | Gastromet | Plexus | Prepulsid | Tono-cis;
  • (PH) Philippines: Prepulsid;
  • (PK) Pakistan: Cisallium | Eupeptol | Minsk | Mopride | Osspride | Prepulsid | Pride | Zorid;
  • (PL) Poland: Coordinax | Gasprid | Gastronax | Prepulsid;
  • (PR) Puerto Rico: Propulsid;
  • (PT) Portugal: Prepulsid;
  • (PY) Paraguay: Ondax | Prepulsid;
  • (RO) Romania: Coordinax | Unipride;
  • (RU) Russian Federation: Cisap | Coordinax | Peristil;
  • (SA) Saudi Arabia: Prepulsid;
  • (SG) Singapore: Prepulsid;
  • (SI) Slovenia: Digenol;
  • (SK) Slovakia: Prepulsid;
  • (TH) Thailand: Cipasid | Cipride | Cisamed | Cisapie | Cisapin | Cisaride | Metison | Motride | Palcid | Persid | Prepulsid | Pri-de-sid | Veesapride;
  • (TN) Tunisia: Prepulsid | Sepride;
  • (TR) Turkey: Desaprid | Dispeprid | Peristal | Prepulsid | Sisarid;
  • (TW) Taiwan: Asamox | Cipr | Cisa | Cisap | Gimove | Goodway | Prepulsid | Prider | Prisic | Topride | Tsupid | Wasow | Wepride;
  • (UA) Ukraine: Cisap | Coordinax | Peristil;
  • (UY) Uruguay: Celaprid | Cisaprida | Cisapridan | Cisapril | Euprandial | Peptax | Peptodual | Prepulsid;
  • (VE) Venezuela, Bolivarian Republic of: Adamin | Cisamod | Cisaprida | Gastrum | Isaprid | Motilar | Prepulsid;
  • (ZA) South Africa: Prepulsid
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