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.
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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.
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NEWS HIGHLIGHTSMedia Articles Related to Propulsid (Cisapride)
Gastroesophageal Reflux Disease (GERD, Heartburn)
Source: MedicineNet Hiatal Hernia Specialty [2008.02.15]
Title: Gastroesophageal Reflux Disease (GERD, Heartburn)
Category: Diseases and Conditions
Created: 12/31/1997
Last Editorial Review: 2/15/2008
World Trade Center Workers Have More Cases of Acid Reflux (HealthDay)
Source: Y! Health Digestive Health News [2009.10.26]
HealthDay - MONDAY, Oct. 26 (HealthDay News) -- World Trade Center rescue
workers can add another illness to the list of health problems that may
have resulted from exposure to Ground Zero toxins and the ensuing mental
anguish of the tragedy -- gastroesophageal reflux disease (GERD).
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.
Clinical Trials Related to Propulsid (Cisapride)
Aprepitant PO vs Ondansetron IV for Prevention of Postoperative Nausea and Vomiting [Recruiting]
Postoperative nausea and vomiting (PONV) persists as one of the more common complications of
surgery. Although rarely life-threatening, it is the postoperative outcome that is most
unfavorable to patients, even more undesirable than pain. Orthognathic surgery corrects
conditions of the jaws and face related to structure, growth, sleep apnea, bad bite, or
congenital malformations. The bones of the face and jaws are cut and placed in a new
position. There is a high rate of PONV in orthognathic surgery (56%). It is particularly
challenging to the patient as their jaws are kept closed together with wires or elastic
bands. Nausea in a patient with restricted mouth opening can be psychologically unnerving and
puts them at risk for fluid in their lungs.
Gan and colleagues showed a higher efficacy of aprepitant over ondansetron in preventing PONV
and nausea severity after open abdominal surgery. From this study, the FDA approved the use
of aprepitant for PONV prevention in patients >18 years of age. Gan suggested further
investigation in different populations.
Our randomized, double-blind, prospective study will compare the efficacy of aprepitant PO
versus ondansetron IV in a high risk setting for PONV: adolescents undergoing orthognathic
surgery.
Our study will involve 200 consecutive, adolescent patients (ages 15-25) who will undergo at
least a Le Fort 1 osteotomy (upper jaw surgery) under general anesthesia and require hospital
admission for at least one night. We will exclude patients who are currently taking
medications that have interactions with aprepitant (pimozide, terfenadine, astemizole,
cisapride), those who have a known vomiting disorder such as bulimia, and those who have
vomited for any reason within 24 hours of surgery. The procedure will be performed by 5
surgeons and general anesthesia will be administered by 3 anesthesiologists at one
institution. A study coordinator, who will not be involved in the treatment, will create the
randomization schedule in order to ensure blindness. The patients will be randomized to
either of two groups: 1) aprepitant 40 mg PO 2) ondansetron 4 mg IV. Appropriate verbal and
written consent will be obtained by the priniciple investigator or surgeon.
On the day of the procedure, all patients will receive a pill (aprepitant or aprepitant
placebo) at least 1 hour prior to induction of anesthesia and an IV infusion (ondansetron or
saline) over 2-5 minutes prior to intubation. The timing and doses of medications will be
consistent with manufacturer's recommendations. An established protocol will ensure every
patient will receive the same anesthetic regiment. Patient's fluid status will be closely
monitored and hydrated appropriately according to known fluid balance calculations.
Efficacy will be assessed based on criteria set by Gan et al and will be based on the
presence/absence of a vomiting episode, use of rescue medication and subjective evaluation of
nausea. Patients will be monitored continuously in the PACU and on the hospital floor by the
caring team (nurse, resident, anesthesiologist, surgeon) for any emetic episode or use of
rescue therapy. An emetic episode is defined as an act of vomiting (oral expulsion of stomach
contents) or retching (non-productive vomiting). Nausea will be assessed at intervals of 0,
2, 6, 24 hours after surgery with T0 being time of extubation. Patients will rate nausea on a
11-point verbal rating scale, with 0 being "not nausea" to 10 being "the worst nausea."
Rescue medication will be offered if the patient has more than one episode of vomiting or
retching, if the patient has nausea lasting longer than 15 minutes, or if the patient
requests it for established nausea or vomiting.
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Page last updated: 2009-10-26
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