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Propulsid

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Propulsid

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(Generic versions may still be available.)

Side Effects
Interactions

SIDE EFFECTS

In the U.S. clinical trial population of 1728 patients (comprising 506 with gastroesophageal reflux disorders, and the remainder with other disorders) the following adverse experiences were reported in more than 1% of patients treated with cisapride and at least as often on cisapride as on placebo. (See TABLE 1.)

TABLE 1
System/Adverse Events Cisapride N=1042 Placebo N=686
 Central & Peripheral Nervous Systems

    Headache

19.3% 17.1%
 Gastrointestinal

    Diarrhea

14.2 10.3

    Abdominal pain

10.2 7.7

    Nausea

7.6 7.6

    Constipation

6.7 3.4

    Flatulence

3.5 3.1

    Dyspepsia

2.7 1.0
 Respiratory System

    Rhinitis

7.3 5.7

    Sinusitis

3.6 3.5

    Coughing

1.5 1.2
 Resistance Mechanism

    Viral infection

3.6 3.2

    Upper respiratory tract infection

3.1 2.8
 Body as a Whole

    Pain

3.4 2.3

    Fever

2.2 1.5
 Urinary System
2.4 1.9

    Micturition frequency

1.2 0.6
 Psychiatric

    Insomnia

1.9 1.3

    Anxiety

1.4 1.0

    Nervousness

1.4 0.7
 Skin & Appendages

    Rash

1.6 1.6

    Pruritus

1.2 1.0
 Musculoskeletal System

    Arthralgia

1.4 1.2
 Vision

    Abnormal vision

1.4 0.3
 Reproductive, Female

    Vaginitis

1.2 0.9


The following adverse events also reported in more than 1% of cisapride patients were more frequently reported on placebo: dizziness, vomiting, pharyngitis, chest pain, fatigue, back pain, depression, dehydration, and myalgia.

Diarrhea, abdominal pain, constipation, flatulence, and rhinitis all occurred more frequently in patients using 20 mg of cisapride than in patients using 10 mg.

Additional adverse experiences reported to occur in 1% or less of patients in the U.S. clinical studies are: dry mouth, somnolence, palpitation, migraine, tremor, and edema.

In other U.S. and international trials and in postmarketing experience, there have been rare reports of seizures and extrapyramidal effects. Also reported have been tachycardia, elevated liver enzymes, hepatitis, thrombocytopenia, leukopenia, aplastic anemia, pancytopenia, and granulocytopenia. The relationship of cisapride to the event was not clear in these cases.

Cardiac arrhythmias, including ventricular tachycardia, ventricular fibrillation, torsades de pointes, and QT prolongation, in some cases resulting in death, have been reported. (See CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and DRUG INTERACTIONS.)

Postmarketing Reports

In addition to the cardiovascular adverse events, the following events have been identified during post-approval use of cisapride in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion in this product information due to a combination of their seriousness, frequency of reporting, or potential causal connection to cisapride: allergic reactions, including bronchospasm, urticaria, and angioedema; possible exacerbation of asthma; psychiatric events, including confusion, depression, suicide attempt, and hallucinations; extrapyramidal effects including akathisia, Parkinson-like symptoms, dyskinetic and dystonic reactions; gynecomastia, female breast enlargement, urinary incontinence, hyperprolactinemia, and galactorrhea.

The Following Events Were Specifically Reported in the Pediatric Population: Antinuclear antibody (ANA) positive, anemia, hemolytic anemia, methemoglobinemia, hyperglycemia, hypoglycemia with acidosis, unexplained apneic episodes, confusion, impaired concentration, depression, apathy, visual changes accompanied by amnesia, and severe photosensitivity reaction.

There have been rare cases of sinus tachycardia reported. Rechallenge precipitated the tachycardia again in some of those patients.

Read the Propulsid (cisapride (removed from us market)) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Cisapride is metabolized mainly via the cytochrome P450 3A4 enzyme. In some cases where serious ventricular arrhythmias, QT prolongation, and torsades de pointes have occurred when cisapride was taken in conjunction with one of the cytochrome P450 3A4 inhibitors, elevated blood cisapride levels were noted at the time of the QT prolongation.

Antibiotics: In vitro and/or in vivo data show that clarithromycin, erythromycin, and troleandomycin markedly inhibit the metabolism of cisapride, which can result in an increase in plasma cisapride levels and prolongation of the QT interval on the ECG.

Anticholinergics: Concurrent administration of certain anticholinergic compounds, such as belladonna alkaloids and dicyclomine, would be expected to compromise the beneficial effects of cisapride.

Anticoagulants (Oral): In patients receiving oral anticoagulants, the coagulation times were increased in some cases. It is advisable to check coagulation time within the first few days after the start and discontinuation of cisapride therapy, with an appropriate adjustment of the anticoagulant dose, if necessary.

Antidepressants: In vitro data indicate that nefazodone inhibits the metabolism of cisapride, which can result in an increase in plasma cisapride levels and prolongation of the QT interval on the ECG.

Antifungals: In vitro and/or in vivo data indicate that fluconazole, itraconazole, and oral ketoconazole markedly inhibit the metabolism of cisapride, which can result in an increase in plasma cisapride levels and prolongation of the QT interval on the ECG. Human pharmacokinetic data indicate that oral ketoconazole markedly inhibits the metabolism of cisapride, resulting in a mean eight-fold increase in AUC of cisapride. A study in 14 normal male and female volunteers suggests that coadministration of cisapride and ketoconazole can result in prolongation of the QT interval on the ECG.

H2 Receptor Antagonists: Cimetidine coadministration leads to an increased peak plasma concentration and AUC of cisapride, there is no effect on cisapride absorption when it is coadministered with ranitidine. The gastrointestinal absorption of cimetidine and ranitidine is accelerated when they are coadministered with cisapride.

Protease Inhibitors: In vitro data indicate that indinavir and ritonavir markedly inhibit the metabolism of cisapride which can result in an increase in plasma cisapride levels and prolongation of the QT interval on the ECG.

Other: Coadministration of grapefruit juice with cisapride increases the bioavailability of cisapride and concomitant use should be avoided.

Cisapride should not be used concomitantly with other drugs known to prolong the QT interval: 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 sertindole); astemizole, bepridil, sparfloxacin, and terodiline. The preceding lists of drugs are not comprehensive.

The acceleration of gastric emptying by cisapride could affect the rate of absorption of other drugs. Patients receiving narrow therapeutic ratio drugs or other drugs that require careful titration should be followed closely; if plasma levels are being monitored, they should be reassessed.

Read the Propulsid Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

Side Effects
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