DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Propulsid (Cisapride) - Summary

 
 



Warning:

Serious cardiac arrhythmias including ventricular tachycardia, ventricular fibrillation, torsades de pointes, and QT prolongation have been reported in patients taking PROPULSID ®. 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 PROPULSID ® 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. (See CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and Drug Interactions.)

Numerous drug classes and agents increase the risk of developing serious cardiac arrhythmias. PROPULSID® is contraindicated in patients taking certain macrolide antibiotics (such as clarithromycin, erythromycin, and troleandomycin), 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). (See PRECAUTIONS: Drug Interactions.) 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 PROPULSID ® without the above-mentioned contraindicated drugs. Most patients had disorders that may have predisposed them to arrhythmias with PROPULSID®. These include history of prolonged electrocardiographic QT intervals or known family history 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. PROPULSID® is contraindicated in patients with these conditions.

A 12-lead ECG should be performed prior to administration of PROPULSID®. Treatment with PROPULSID® 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 PROPULSID® and whenever conditions develop that may affect electrolyte balance or renal function. (See DOSAGE AND ADMINISTRATION.)

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

Recommended doses of PROPULSID ® should not be exceeded.

 

PROPULSID SUMMARY

PROPULSID®
(cisapride)
TABLETS/SUSPENSION

PROPULSID (cisapride) Tablets and Suspension contain cisapride, an oral gastrointestinal agent.

PROPULSID (cisapride) is indicated for the symptomatic treatment of adult patients with nocturnal heartburn due to gastroesophageal reflux disease. Because of the risk of serious, and sometimes fatal, ventricular arrhythmias (see Boxed Warning), PROPULSID should generally be reserved for patients who do not respond adequately to lifestyle modifications (See PRECAUTIONS: Information for Patients and Medication Guide), antacids and gastric acid reducing agents.


See all Propulsid indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Propulsid (Cisapride)

Gastroesophageal Reflux Disease (GERD)
Source: MedicineNet Helicobacter Pylori Specialty [2017.05.10]
Title: Gastroesophageal Reflux Disease (GERD)
Category: Symptoms and Signs
Created: 10/13/2003 12:00:00 AM
Last Editorial Review: 5/10/2017 12:00:00 AM

Acid Reflux (Gastroesophageal Reflux Disease or GERD)
Source: MedicineNet calcium carbonate Specialty [2017.05.05]
Title: Acid Reflux (Gastroesophageal Reflux Disease or GERD)
Category: Symptoms and Signs
Created: 12/4/2013 12:00:00 AM
Last Editorial Review: 5/5/2017 12:00:00 AM

more news >>

Published Studies Related to Propulsid (Cisapride)

Domperidone versus cisapride in the treatment of infant regurgitation and increased acid gastro-oesophageal reflux: a pilot study. [2009.04]
AIM: Although domperidone is used frequently to treat infant regurgitation, efficacy data are scarce. Cisapride was previously used in the same indication... CONCLUSION: The decrease in regurgitation was comparable in both groups, although acid reflux decreased more in the cisapride group. Cisapride induced QT prolongation in one infant.

The effects of bethanechol and cisapride on urodynamic parameters in patients undergoing radical hysterectomy for cervical cancer. A randomized, double-blind, placebo-controlled study. [2006.05]
To evaluate the effects of bethanechol and cisapride on urodynamic parameters in patients undergoing radical hysterectomy for cervical cancer. In this double-blind, placebo-controlled study, 79 patients with cervical cancer were randomized to receive bethanechol (30 mg/day), cisapride (30 mg/day), bethanechol combined with cisapride (same doses) and placebo...

A randomized trial comparing omeprazole, ranitidine, cisapride, or placebo in helicobacter pylori negative, primary care patients with dyspepsia: the CADET-HN Study. [2005.07]
BACKGROUND: The management of Helicobacter pylori negative patients with dyspepsia in primary care has not been studied in placebo-controlled studies... CONCLUSION: Treatment with omeprazole provides superior symptom relief compared to ranitidine, cisapride, and placebo in the treatment of H. pylori negative primary care dyspepsia patients.

Norfloxacin and cisapride combination decreases the incidence of spontaneous bacterial peritonitis in cirrhotic ascites. [2005.04]
BACKGROUND: Spontaneous bacterial peritonitis (SBP) is a serious complication of cirrhosis with ascites, having high recurrence despite antibiotic prophylaxis. Small bowel dysmotility and bacterial overgrowth have been documented to be related to SBP. The purpose of the present paper was (i) to study whether addition of a prokinetic agent to norfloxacin ameliorates the development of SBP in high-risk patients; and (ii) to identify risk factors for SBP development... CONCLUSIONS: Prophylaxis with norfloxacin and cisapride significantly reduces the incidence of SBP in high-risk cirrhosis patients; low serum albumin, low ascitic fluid protein and alcoholic cirrhosis predispose to the development of SBP in high-risk cirrhosis patients; and low ascitic fluid protein should also be considered as a risk factor for the development of SBP requiring prophylaxis.

The administration of cisapride as an adjuvant to PEG-electrolyte solution for colonic cleansing: a double-blind randomized study. [2005.03]
CONCLUSIONS: The administration of cisapride to patients undergoing colonic lavage may be an effective adjuvant to PEG-electrolyte solution particularly with respect to increase patient acceptability.

more studies >>

Clinical Trials Related to Propulsid (Cisapride)

A Study of Cisapride in Premature Infants With Feeding Problems [Terminated]
The purpose of this study is to evaluate the effectiveness of Cisapride in improving feeding problems in premature newborn infants.

A Study of Cisapride in Patients With Symptomatic Gastro-Oesophageal Reflux Disease [Terminated]
The purpose of this study is to compare the efficacy and tolerability of cisapride with placebo in infants and children with gastro-oesophageal reflux disease (GORD).

An Efficacy and Safety Study of Cisapride in Patients With Chronic Gastroparesis After Failure of Other Treatment Options [Terminated]
The purpose of this study is to assess the effectiveness of cisapride in patients with a primary diagnosis of chronic gastroparesis (a stomach disorder) of unknown cause.

An Efficacy and Safety Study of Cisapride for Improving Symptoms Associated With Gastroparesis in Patients With Diabetes Mellitus [Terminated]
The purpose of this study is to assess the effectiveness of cisapride at improving symptoms associated with gastroparesis (a stomach disorder) in patients with diabetes mellitus.

Limited Access Protocol for the Use of Oral Cisapride [Completed]
Due to the lack of other drugs to treat gastroparesis Janssen and FDA approved the compassionate use of cisapride to treat patients who had no other effective therapy. For this observational study, 3 patients who had already been prescribed cisapride by outside physicians, were followed to determine the effectiveness of cisapride on their gastric emtpying.

more trials >>

Reports of Suspected Propulsid (Cisapride) Side Effects

Electrocardiogram QT Prolonged (27)Drug Ineffective (2)Palpitations (2)Atrial Fibrillation (2)Arrhythmia (2)Asperger's Disorder (1)Pneumonia Legionella (1)Food Intolerance (1)Constipation (1)Adverse Event (1)more >>


Page last updated: 2017-05-10

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017