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PATIENT PACKAGE INSERT

READ COMPLETELY BEFORE USE. If you have a medical condition or take a drug listed here, including erythromycin (such as E.E.S., E-Mycin, Ilotycin, Pediazole), clarithromycin (Biaxin) or fluconazole (Diflucan), Do Not Take Cisapride.

Brand Name: PROPULSID (cisapride (removed from us market)) (pro-pul-sid)

Generic Name: Cisapride

Available As: 10 mg & 20 mg tablets (P/10, P/20)

1 mg/ml suspension (liquid form).

What is the Most Important Information I Should Know About Cisapride?

Cisapride may cause serious irregular heartbeats that may be fatal. Taking cisapride together with certain other medicines increases the likelihood that you will have irregular heartbeats. Cisapride should never be taken with these other medicines. A list of these medicines is supplied below (see Who Should Not Take Cisapride?). If you faint or feel faint, become dizzy or have irregular heartbeats while using cisapride, stop taking your medication and seek medical attention immediately.

What is Cisapride?

Cisapride is a medication intended only to treat the symptoms of nighttime heartburn in adults. Nocturnal, or nighttime, heartburn is a common symptom of a medical condition called gastroesophageal reflux disease (GERD). It occurs when stomach contents wash back, or "reflux," into the esophagus (a muscular tube that carries food from the mouth to the stomach). Reflux is very common at nighttime because stomach contents can easily wash backwards when you are lying down. Usually, physicians recommend that patients with nighttime heartburn make simple lifestyle changes and use antacids or acid-reducing agents to relieve their symptoms. (See What Else Can I do for Nighttime Heartburn? for more details.) These other medications should be tried first because of the risk of serious, and sometimes fatal, irregular heartbeats associated with the use of cisapride.

Who Should Not Take Cisapride?

Some patients who have taken certain medications together with cisapride have experienced serious problems such as fainting, dizziness, and irregular heartbeats. These interactions can be fatal. Medications that should not be taken with cisapride include:

Antibiotics:   Erythromycin (such as E.E.S., E-Mycin, Ilotycin, Pediazole), clarithromycin (Biaxin), troleandomycin (TAO).

Antidepressants:   Nefazodone (Serzone).

Antifungals:   Fluconazole (Diflucan), itraconazole (Sporanox), oral ketoconazole (Nizoral).

Protease Inhibitors:   Indinavir (Crixivan), ritonavir (Norvir).

Also, you should not take cisapride with certain heart medications and certain allergy medications. There are also other medications that are handled by your body in the same way as the drugs listed above and may cause the same serious problems (fainting, dizziness, and possibly fatal irregular heartbeats) when taken with cisapride.

• Tell your doctor about all other drugs you are taking, especially diuretics ("water pills") and heart medications. While taking cisapride, do not start a new medicine without first consulting your doctor or pharmacist.
• Cisapride should not be used in patients with certain medical conditions. In particular, tell your doctor if you have any type of heart condition or kidney or lung disease before taking cisapride. Be sure your doctor knows about your personal and family medical history.
• If you have not tried other medications to relieve your nighttime heartburn, tell your doctor before using cisapride.
• The safety and effectiveness of cisapride in children younger than 16 years have not been demonstrated for any use. Serious adverse events, including death, have been reported in infants and children while being treated with cisapride, although there is no conclusive evidence that cisapride caused them.

How Should I Take Cisapride?

• Take cisapride exactly as your doctor prescribes it. Cisapride does not work for everyone. If you do not get relief of your nighttime heartburn, talk to your doctor about whether to stop using cisapride.
• Never take more than the recommended dose of cisapride. Always take your medication for as long as the doctor has prescribed it, even if you are beginning to feel better right away.
• If you forget to take a dose, do not take the missed dose. Take the next dose at the regularly scheduled time. Never take more than your normal dose at any one time to make up for the missed dose.

What Should I Avoid While Taking Cisapride?

• Never take cisapride with the medications listed in Who Should Not Take Cisapride?
• Do not take cisapride with grapefruit juice.
• Tell your doctor if you are pregnant or nursing. Your doctor will recommend whether you should take cisapride while pregnant or nursing, based on the benefits and risks.

What are the Possible Side Effects of Cisapride?

• If you faint or feel faint, become dizzy or have irregular heartbeats while using cisapride, stop taking it and contact your doctor immediately. Call your doctor if you experience any unusual symptoms after or while taking cisapride.
• All prescription medications have some potential side effects for some users. The most common side effects associated with cisapride are headache, diarrhea, stomach pain, nausea, constipation, and a runny nose. Other side effects have been reported less frequently. Be sure to ask your doctor or pharmacist about the side effects of any medication you are taking, including cisapride.

What Else Can I do for Nighttime Heartburn?

• Stop smoking or reduce the number of cigarettes you smoke
• Elevate the head of your bed when you sleep
• Avoid eating large meals or eating just before bedtime
• Do not lie down right after eating
• If you are overweight or your doctor recommends it, try to lose weight
• Avoid fatty foods and foods containing chocolate, caffeine or citrus
• Avoid alcoholic beverages

All of these lifestyle changes will help to restore your body to a more normal way of functioning.

General Information

This information provides a summary about cisapride. Medicines are sometimes prescribed for purposes other than those listed in the PATIENT PACKAGE INSERT. If you have additional questions or concerns, need to report problems associated with the use of cisapride, or want more information about cisapride, contact your doctor or pharmacist. You can also call the Janssen One-to-One Customer Action Center toll-free at 1-800-526-7736 for more information. This medication was prescribed for your particular condition. Do not use it for another condition or give the drug to others.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.