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Prepulsid

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Indications:

The symptomatic management of gastrointestinal motility disorders including: gastroesophageal reflux disease; gastroparesis, idiopathic or associated with diabetic neuropathy; and intestinal pseudo-obstruction.Also for the prophylaxis o gastroesophageal reflux disease.

Contraindications:

The concomitant oral or parenteral use of the following potent cytochrome P450 3A4 inhibiting drugs may lead to elevated cisapride blood levels and is contraindicated. Antifungals: oral or i.v. fluconazole, itraconazole, ketoconazole. Antibiotics: oral or i.v. erythromycin, clarithromycin. Protease Inhibitors: ritonavir, indinavir (in vitro studies suggest that saquinavir is only a weak inhibitor). Antidepressants: nefazodone. Cisapride is also contraindicated for patients with: history of prolonged electrocardiographic QT intervals; renal failure; history of ventricular arrhythmias, ischemic heart disease, and congestive heart failure; uncorrected electrolyte disorders (hypokalemia, hypomagnesemia or in patients who might experience rapid reduction of plasma potassium such as those administered potassium-wasting diuretics and/or insulin in acute settings); 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 and terfenadine. The preceding lists of drugs are not comprehensive. Cisapride is contraindicated in prematurely born infants (born at gestational age of less than 36 weeks), from 0 through 3 months after the delivery date. Cisapride is contraindicated in patients with known sensitivity or intolerance to the drug. Cisapride is contraindicated whenever gastrointestinal stimulation might be dangerous, i.e., gastrointestinal hemorrhage, mechanical obstruction or perforation. (See also Warnings and Precautions, Drug Interactions.) Manufacturers’ Warnings In Clinical States: 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. Cisapride is contraindicated in patients taking any of these drugs. Some of these contraindicated drugs are listed in the Contraindications section. Some of these patients did not have cardiac disease. However, most had been receiving multiple other medications and had pre-existing cardiac disease or risk factors for arrhythmias. 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. Some of these events have been fatal. Cisapride is contraindicated in patients with the following risk factors for cardiac arrhythmia: uncorrected electrolyte disturbances (hypokalemia, hypomagnesemia such as seen in patients taking potassium-wasting diuretics, severe dehydration, vomiting, malnutrition, or in patients who might experience a rapid reduction of plasma potassium, such as insulin administered in acute settings), renal failure (particularly when on chronic dialysis), chronic obstructive pulmonary disease, respiratory failure, conditions associated with QT prolongation (such as congenital long QT syndrome, idiopathic QT prolongation, QT prolongation associated with diabetes mellitus, combination with medications known to prolong the QT interval), prolonged QT interval at baseline and history of significant cardiac disease (including serious ventricular arrhythmia, torsades de pointes, second or third degree AV block, congestive heart failure, ischemic heart disease and sinus node dysfunction). Additionally, concomitant medications known to prolong the QT interval risk of arrhythmia, such as certain antiarrhythmics, including those of Class 1A (such as but not limited to quinidine and procainamide) and Class III (such as but not limited to amiodarone and sotalol); tricyclic antidepressants (such as but not limited to amitriptyline); certain tetracyclic antidepressants (such as but not limited to maprotiline); certain antipsychotic medications (such as but not limited to certain phenothiazines); astemizole and terfenadine should also be avoided. The preceding lists of drugs are not comprehensive. Potential benefits should be weighed against risks prior to the administration of cisapride to patients who have, or may develop prolongation of cardiac conduction intervals, particularly QTc. In addition, patients with or suspected of having the above risk factors should be evaluated prior to the administration of cisapride. An ECG should be considered as part of this evaluation to exclude a prolonged QT interval.

Adverse reactions:

Serious cardiac arrhythmias including ventricular tachycardia, ventricular fibrillation, torsades de pointes, and QT prolongation have been reported in patients taking cisaprideDiarrhea, nausea, headache, stuffy nose, constipation or coughing may occur infrequently as your body adjusts to the medication. If any of these effects persist or worsen, inform your doctor promptly. Notify your doctor if you develop vision changes, chest pain, mental/mood changes or stomach pain while taking this medication. Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: dizziness, fainting, irregular heartbeat. In the unlikely event you have an allergic reaction to this drug, seek immediate medical attention. Symptoms of an allergic reaction include: rash, itching, swelling, dizziness, trouble breathing. If you notice

Interactions:

The main metabolic pathway of cisapride is through cytochrome P450 3A4. In some cases where serious cardiac arrhythmias 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 QT prolongation. Therefore, the use of such drugs is contraindicated. Examples of these drugs include the following: Antifungals: oral or i.v. fluconazole, itraconazole, ketoconazole. Antibiotics: oral or i.v. erythromycin, clarithromycin. Protease Inhibitors: ritonavir, indinavir (in vitro studies suggest that saquinavir is only a weak inhibitor). Antidepressants: nefazodone. Additionally, concomitant medications known to prolong the QT interval and increase the risk of arrhythmia, such as certain antiarrhythmics, including those of Class 1A (such as but not limited to quinidine and procainamide) and Class III (such as but not limited to amiodarone and sotalol); tricyclic antidepressants (such as but not limited to amitriptyline); certain tetracyclic antidepressants (such as but not limited to maprotiline); certain antipsychotic medications (such as but not limited to certain phenothiazines); astemizole and terfenadine should also be avoided. The preceding lists of drugs are not comprehensive. (See also Contraindications, Warnings and Adverse Effects.) Since cisapride accelerates gastric emptying, the absorption from the stomach of other concomitantly administered drugs may be diminished whereas absorption of drugs from the small bowel may be accelerated. In the case of drugs that require careful individual titration, such as anticonvulsants, it may be useful to monitor the plasma levels of such drugs when cisapride is given concomitantly. In patients receiving anticoagulants, the coagulation times may increase. It is advisable to check the coagulation time within the first few days after the initiation and termination of cisapride therapy, with appropriate adaptation of the anticoagulant dose, if necessary. Although cisapride does not affect psychomotor function, nor does it induce sedation or drowsiness when used alone, the sedative effects of benzodiazepines and of alcohol may be enhanced by cisapride. The beneficial effects of cisapride on gastrointestinal motility are largely antagonized by anticholinergic drugs. The oral bioavailability of cisapride increases slightly when used concomitantly with cimetidine or ranitidine; this is not considered to be clinically significant. Patients With Hepatic or Renal Insufficiency: Because of the importance of the liver and kidneys in the metabolism and excretion of cisapride, the daily dose should be halved in patients with hepatic or renal insufficiency (see Dosage). Geriatrics: Steady-state plasma levels of cisapride are generally higher than those of younger patients, due to a moderate prolongation of the elimination half-life. Initial therapeutic doses are similar to those used in younger patients but afterwards this dose can be adjusted depending on the therapeutic effects or possible side effects. The rate of common adverse experiences in patients greater than 65 years of age in clinical trials was similar to that in younger adults. Pregnancy: In a large population study in humans, cisapride has shown no increase in fetal anomalies. However, the anticipated therapeutic benefits should be weighed against potential hazards before giving cisapride during pregnancy, especially during the first trimester. Lactation: Although the excretion of cisapride in human breast milk is minimal, it is advisable to discontinue breast-feeding while taking cisapride.

Warnings:

General: Before initiating therapy with cisapride, organic disease such as gastrointestinal hemorrhage, mechanical obstruction or perforation should be excluded by the physician.

Form:

SUSPENSION

Dosage and Administration

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