In the U.S.—

In Canada—

• Cholinergic enhancer
• Gastrointestinal emptying (delayed) adjunct

Cisapride (SIS-a-pride) is a medicine that increases the movements or contractions of the stomach and intestines. It is used to treat symptoms such as heartburn caused by a backward flow of stomach acid into the esophagus.

Cisapride will only be available in the U.S. to certain patients who meet eligibility criteria from the manufacturer. Your doctor must enroll in a special program in order to prescribe this medicine for you. Cisapride is not available in Canada.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For cisapride, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to cisapride. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Cisapride has not been studied in pregnant women. However, studies in animals have shown that cisapride causes harm to the fetus. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding— Cisapride passes into breast milk and may cause unwanted effects in nursing babies, particularly if the infant or mother are taking certain other medicines. Be sure you have discussed the risks and benefits of this medicine with your doctor.

Children— Cisapride can cause serious side effects in any patient. Therefore, it is especially important that you discuss with the child's doctor the good that this medicine may do, as well as the risks of using it.

Older adults—Elderly people are especially sensitive to the effects of cisapride. Cisapride stays in the body longer so the dose may be different than in younger people.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking cisapride, it is especially important that your health care professional know if you are taking any of the following:

• Amantadine (e.g., Symmetrel) or
• Anticholinergics (medicine for abdominal or stomach spasms or cramps) or
• Antidepressants (medicine for depression) or
• Antidyskinetics (medicine for Parkinson's disease or other conditions affecting control of muscles) or
• Antihistamines, except cetirizine (e.g., Reactine), and loratadine (e.g., Claritin) or
• Antipsychotics (medicine for mental illness) or
• Buclizine (e.g., Bucladin) or
• Carbamazepine (e.g., Tegretol) or
• Cyclizine (e.g., Marezine) or
• Cyclobenzaprine (e.g., Flexeril) or
• Disopyramide (e.g., Norpace) or
• Ipratropium (e.g., Atrovent) or
• Meclizine (e.g., Antivert) or
• Orphenadrine (e.g., Norflex) or
• Oxybutynin (e.g., Ditropan) or
• Promethazine (e.g., Phenergan) or
• Trimeprazine (e.g., Temaril)—Cisapride may decrease the absorption of these medicines and cause them to be less effective

• Bepridil (e.g., Bepadin, Vascor) or
• Bumetanide (e.g., Bumex) or
• Clarithromycin (e.g., Biaxin) or
• Erythromycin (e.g., E-Mycin) or
• Ethacrynic acid (e.g., Edecrin) or
• Fluconazole (e.g., Diflucan) or
• Furosemide (e.g., Lasix) or
• Indinavir (e.g., Crixivan) or
• Itraconazole (e.g., Sporanox) or
• Ketoconazole (e.g., Nizoral) or
• Miconazole (e.g., Monistat i.v.) or
• Nefazodone (e.g., Serzone) or
• Nelfinivir (e.g., Viracept) or
• Procainamide (e.g., Pronestyl) or
• Quinidine (e.g., Quinidex) or
• Ritonavir (e.g., Norvir) or
• Saquinavir (e.g., Invirase) or
• Sotalol (e.g., Betapace, Sotacor) or
• Sparfloxacin (e.g., Zagam) or
• Terodiline (e.g., Micturin) or
• Troleandomycin (e.g., Tao)—These medicines may increase the chance of serious side effects and should not be taken with cisapride

• Diuretics (water pills)—These medicines may increase the chance of serious side effects from cisapride

• Abdominal or stomach bleeding or
• Intestinal blockage—Cisapride may make these conditions worse

• Heart disease or
• Kidney disease, severe, or
• Low potassium blood levels or
• Lung disease, severe—Cisapride may cause an increased risk of serious heart rhythm problems

Take this medicine 15 minutes before meals and at bedtime with a beverage , unless otherwise directed by your doctor.

Grapefruit and grapefruit juice may increase the effects of cisapride by increasing the amount of this medicine in the body. You should not eat grapefruit or drink grapefruit juice while you are taking this medicine.

Dosing—

The dose of cisapride will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of cisapride. If your dose is different, do not change it unless your doctor tells you to do so.

• For oral dosage forms (tablets and suspension):
  • For heartburn caused by gastroesophageal reflux:
    • Adults and children 12 years of age and older—5 to 20 milligrams (mg) of cisapride two to four times a day. Cisapride should be taken fifteen minutes before meals and at bedtime.
    • Children up to 12 years of age—Dose is based on body weight and must be determined by your doctor. The dose is usually 0.15 to 0.3 mg of cisapride per kilogram (0.07 to 0.14 mg per pound) of body weight three to four times a day, fifteen minutes before meals.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

This medicine may cause your body to absorb alcohol more quickly than you normally would. Therefore, you may notice the effects sooner. Check with your doctor before drinking alcohol while you are using this medicine .

This medicine may cause some people to become dizzy, drowsy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if the following side effect occurs:

• Rare
  • Blurred vision or other changes in vision;  convulsions (seizures);  dizziness;  fainting or feeling faint;  fast or racing heartbeat ;  pounding or irregular heartbeat;  swelling of face, hands, lower legs, and/or feet;  unusual weight gain 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

• Less common or rare
  • Abdominal pain or cramping;  constipation ;  diarrhea;  drowsiness;  dryness of mouth;  gas;  headache;  heartburn or indigestion;  nausea;  runny nose;  tremor;  unusual tiredness or weakness 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.