Cisapride

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Cisapride Brand Name– Propulsid

What is Cisapride

Cisapride is an oral gastrointestinal prokinetic agent indicated for the treatment of gastroesophageal reflux disease (GERD).

Although chemically similar to metoclopramide, cisapride lacks the central nervous system-depressant and antidopaminergic effects that can occur with metoclopramide.

In comparative trials of cisapride with metoclopramide and H2-blockers in patients with GERD, cisapride was shown to be at least as effective as these agents.

Also, combination therapy with cisapride and either cimetidine or ranitidine produced higher healing rates than did either agent alone in the treatment of esophagitis.

Cisapride has been used off-label in the treatment of children with GERD and in adults with diabetic gastroparesis.

Cisapride has been associated with QT prolongation and torsade de pointes, particularly when used in combination with other drugs that inhibit its clearance.

There are many contraindications to the use of cisapride. Due to the potential for serious cardiac events, the drug should only be used in circumstances where other therapeutic measures have failed to provide adequate responses.

As of May 2000, the manufacturer of cisapride will only provide the agent via investigational protocols of a limited-access program to patients who are unresponsive to other medications.

The three investigational protocols include: a) In adults, for gastroesophageal reflux disease (GERD), gastroparesis, pseudo-obstruction, and severe chronic constipation; b) In pediatrics, refractory GERD (associated with failure to thrive, asthma, bradycardia, apnea, or other serious conditions) or pseudo-obstruction and c) In neonates, for feeding intolerance.

After July 2000, the drug will be available to patients only via registered prescribers in accordance with these protocols and clearly defined eligibility criteria.

The drug will not be available in pharmacies after August 2000. For information, the manufacturer has provided the following toll-free number 877—795—4247.

Cisapride was initially FDA approved for the treatment of GERD in July 1993; and usage was changed to IND status as of May 2000.

Indications

  1. diabetic gastroparesis
  2. esophagitis
  3. gastroesophageal reflux disease (GERD)
  4. gastroparesis

For the treatment of gastroesophageal reflux disease (GERD)

Side Effects

  1. abdominal pain
  2. anxiety
  3. arthralgia
  4. back pain
  5. constipation
  6. cough
  7. dehydration
  8. depression
  9. diarrhea
  10. dizziness
  11. dyspepsia
  12. fatigue
  13. flatulence
  14. headache
  15. insomnia
  16. myalgia
  17. nausea
  18. pharyngitis
  19. pruritus
  20. QT prolongation
  21. rhinitis
  22. torsade de pointes
  23. ventricular fibrillation
  24. ventricular tachycardia
  25. visual impairment
  26. vomiting

Monitoring Parameters

  • ECG
  • serum creatinine/BUN
  • serum electrolytes

Contraindications

  • anorexia nervosa
  • anuria
  • apheresis
  • AV block
  • bradycardia
  • breast-feeding
  • bundle-branch block
  • cardiomyopathy
  • celiac disease
  • children
  • chronic obstructive pulmonary disease (COPD)
  • dehydration
  • diabetic ketoacidosis
  • diarrhea
  • electrolyte imbalance
  • ethanol intoxication
  • females
  • fever
  • geriatric
  • GI bleeding
  • GI obstruction
  • GI perforation
  • heart failure
  • hepatic disease
  • hepatic encephalopathy
  • human immunodeficiency virus (HIV) infection
  • hyperparathyroidism
  • hypocalcemia
  • hypokalemia
  • hypomagnesemia
  • hypothermia
  • hypothyroidism
  • hypovolemia
  • ileus
  • infants
  • long QT syndrome
  • myocardial infarction
  • neonates
  • pheochromocytoma
  • pregnancy
  • premature neonates
  • QT prolongation
  • renal failure
  • renal impairment
  • respiratory insufficiency
  • rheumatoid arthritis
  • sick sinus syndrome
  • sickle cell disease
  • sleep deprivation
  • stroke
  • syncope
  • systemic lupus erythematosus (SLE)
  • tobacco smoking
  • torsade de pointes
  • valvular heart disease
  • ventricular arrhythmias
  • ventricular dysfunction
  • ventricular fibrillation
  • ventricular tachycardia
  • vomiting

Interactions

  • Abarelix
  • Acarbose
  • Acetazolamide
  • Alfuzosin
  • Aliskiren; Amlodipine
  • Aliskiren; Amlodipine; Hydrochlorothiazide, HCTZ
  • Alogliptin; Metformin
  • Alosetron
  • Alpha-glucosidase Inhibitors
  • Alprazolam
  • Amiodarone
  • Amitriptyline; Chlordiazepoxide
  • Amlodipine
  • Amlodipine; Atorvastatin
  • Amlodipine; Benazepril
  • Amlodipine; Celecoxib
  • Amlodipine; Hydrochlorothiazide, HCTZ; Olmesartan
  • Amlodipine; Hydrochlorothiazide, HCTZ; Valsartan
  • Amlodipine; Olmesartan
  • Amlodipine; Telmisartan
  • Amlodipine; Valsartan
  • Amoxicillin; Clarithromycin; Lansoprazole
  • Amoxicillin; Clarithromycin; Omeprazole
  • Amphotericin B
  • Amphotericin B cholesteryl sulfate complex (ABCD)
  • Amphotericin B lipid complex (ABLC)
  • Amphotericin B liposomal (LAmB)
  • Anagrelide
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  • Asenapine
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  • Atomoxetine
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  • Atropine; Benzoic Acid; Hyoscyamine; Methenamine; Methylene Blue; Phenyl Salicylate
  • Atropine; Difenoxin
  • Atropine; Diphenoxylate
  • Atropine; Edrophonium
  • Atropine; Hyoscyamine; Phenobarbital; Scopolamine
  • Azithromycin
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  • grapefruit juice
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  • Phenylephrine; Promethazine
  • Phenytoin
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  • Voriconazole
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  • Zileuton
  • Ziprasidone

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