Cisapride (patient information)

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IMPORTANT WARNING

Cisapride is only available in the United States to special patients who are signed up by their doctors. Talk to your doctor or pharmacist about whether you should be taking cisapride.

Cisapride may cause serious irregular heart beats, which can lead to death. Tell your doctor if you have a family history of heart problems and if you have or have ever had irregular heart beats, heart disease, severe dehydration, vomiting, eating disorders, or kidney or lung failure.

Tell your doctor about all the prescription and nonprescription medications you are taking. Do not take cisapride if you are taking bepridil (Vascor); chlorpromazine (Thorazine); clarithromycin (Biaxin); erythromycin (E.E.S., E-Mycin, Ery-Tab); fluconazole (Diflucan); fluphenazine (Prolixin); itraconazole (Sporanox); ketoconazole (Nizoral); medications for depression such as amitriptyline (Elavil), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Adapin, Sinequan), imipramine (Tofranil), maprotiline (Ludiomil), nefazodone (Serzone), nortriptyline (Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil); medications for irregular heart beats such as amiodarone (Cordarone), disopyramide (Norpace), quinidine (Quinidex), procainamide (Procanbid, Pronestyl), and sotalol (Betapace); mesoridazine (Serentil); perphenazine (Trilafon); prochlorperazine (Compazine); promethazine (Phenergan); protease inhibitors such as indinavir (Crixivan) and ritonavir (Norvir); sertindole (Serlect); sparfloxacin (Zagam); thioridazine (Mellaril); thiothixene (Navane); trifluoperazine (Stelazine); or troleandomycin (Tao). Do not drink grapefruit juice while taking cisapride.

Do not take more of cisapride or take it more often than prescibed by your doctor. Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to cisapride.

If you experience either of the following symptoms, call your doctor immediately: fainting or irregular or fast heartbeats.

Why this medication is prescribed

Cisapride is used to treat symptoms of nighttime heartburn in people who have not responded to other treatments.

How this medication should be used

Cisapride comes as a tablet and liquid to take by mouth. Cisapride usually is taken four times a day, 15 minutes before meals and at bedtime. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take cisapride exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Other uses for this medicine

This medication should not be prescribed for other uses; ask your doctor or pharmacist for more information.

Special precautions

Before taking cisapride:

• tell your doctor and pharmacist if you are allergic to cisapride or any other drugs.
• in addition to the medications listed in the IMPORTANT WARNING section, tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially antianxiety medications, anticholinergics (atropine, belladonna, benztropine, dicyclomine, diphenhydramine, isopropamide, procyclidine, and scopolamine), anticoagulants ('blood thinners') such as warfarin (Coumadin), azithromycin (Zithromax), cimetidine (Tagamet), dirithromycin (Dynabac), diuretics ('water pills'), miconazole (Monistat), tranquilizers, and vitamins.
• tell your doctor if you have or have ever had intestinal disorders or bleeding ulcers.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking cisapride, call your doctor.
• you should know that this drug may make you drowsy. Do not drive a car or operate machinery until you know how this drug affects you.
• remember that alcohol can add to the drowsiness caused by this drug.

What to do if you forget a dose

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Side effects

Minor side effects

Cisapride may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• upset stomach
• stomach discomfort
• headache
• stuffy nose
• constipation
• coughing

Severe side effects

If you experience any of the following symptoms or those listed in the IMPORTANT WARNING section call your doctor immediately:

• vision changes
• chest pain

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/report.htm] or by phone [1-800-332-1088].

Storage conditions needed for this medication

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Other information

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to cisapride.

Do not let anyone else take your medicine. Ask your pharmacist any questions you have about refilling your prescription.

Brand names

• Propulsid®