Pronunciation:

SIS-a-pride

Brand Names:

• Novo-Cisapride
• Prepulsid

Dosage Forms:

• Suspension
• Tablet

Classifications:

Therapeutic

Stimulant, Gastrointestinal

Uses of This Medicine:

Cisapride 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.

This medicine was available only with your doctor's prescription.

Janssen Pharmaceutica stopped marketing Propulsid® (cisapride) and has made it available only through an investigational limited access program .

Before Using This Medicine:

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

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.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Acecainide
• Acetophenazine
• Ajmaline
• Amiodarone
• Amisulpride
• Amitriptyline
• Amoxapine
• Amprenavir
• Aprepitant
• Aprindine
• Arsenic Trioxide
• Astemizole
• Atazanavir
• Azimilide
• Bepridil
• Bretylium
• Chloral Hydrate
• Chloroquine
• Chlorpromazine
• Clarithromycin
• Clomipramine
• Dalfopristin
• Darunavir
• Delavirdine
• Desipramine
• Diltiazem
• Disopyramide
• Dofetilide
• Dolasetron
• Dothiepin
• Doxepin
• Dronedarone
• Droperidol
• Efavirenz
• Enflurane
• Erythromycin
• Ethopropazine
• Flecainide
• Fluconazole
• Fluphenazine
• Fluvoxamine
• Fosamprenavir
• Fosaprepitant
• Foscarnet
• Gatifloxacin
• Gemifloxacin
• Grepafloxacin
• Halofantrine
• Haloperidol
• Halothane
• Ibutilide
• Imipramine
• Indinavir
• Isoflurane
• Isradipine
• Itraconazole
• Ketoconazole
• Levomethadyl
• Lidoflazine
• Lofepramine
• Lorcainide
• Maprotiline
• Mefloquine
• Mesoridazine
• Methadone
• Methotrimeprazine
• Mibefradil
• Moricizine
• Moxifloxacin
• Nefazodone
• Nelfinavir
• Nortriptyline
• Octreotide
• Opipramol
• Pentamidine
• Perphenazine
• Pimozide
• Pipotiazine
• Pirmenol
• Posaconazole
• Prajmaline
• Probucol
• Procainamide
• Prochlorperazine
• Promazine
• Promethazine
• Propafenone
• Propiomazine
• Protriptyline
• Quetiapine
• Quinidine
• Quinupristin
• Ranolazine
• Recainam
• Risperidone
• Ritonavir
• Saquinavir
• Sematilide
• Sertindole
• Sotalol
• Sparfloxacin
• Spiramycin
• Sulfamethoxazole
• Sultopride
• Tedisamil
• Telithromycin
• Terfenadine
• Terodiline
• Thiethylperazine
• Thioridazine
• Tipranavir
• Trifluoperazine
• Triflupromazine
• Trimeprazine
• Trimethoprim
• Trimipramine
• Troleandomycin
• Vasopressin
• Voriconazole
• Ziprasidone
• Zolmitriptan
• Zotepine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Iloperidone
• Lapatinib
• Lumefantrine
• Nilotinib
• Sunitinib
• Tetrabenazine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acenocoumarol
• Anisindione
• Betel Nut
• Cyclosporine
• Dicumarol
• Nevirapine
• Phenindione
• Phenprocoumon
• Warfarin

Other interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Using this medicine with any of the following is not recommended. Your doctor may decide not to treat you with this medication, change some of the other medicines you take, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other medical problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• 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.

Proper Use of This Medicine:

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 this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• 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

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using This Medicine:

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.

Side Effects of This Medicine:

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 any of the following side effects occur:

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

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

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 may also occur in some patients. If you notice any other effects, check with your healthcare professional.