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cisapride, Propulsid

GENERIC NAME: cisapride

BRAND NAME: Propulsid

IMPORTANT NEWS ALERT - The U.S. Food and Drug Administration (FDA) has issued an urgent warning regarding cisapride (Propulsid) which has been found to cause cardiac arrhythmias (irregular heart rhythms). All patients taking cisapride have been advised to contact their doctors. The manufacturer of cisapride, Janssen Pharmaceutica, will remove cisapride from pharmacies by July of 2000; however, Janssen plans to make the drug available for patients with unusual, debilitating problems for whom there is no alternative therapy.

DRUG CLASS AND MECHANISM: Cisapride is a "prokinetic" agent that increases muscle contractions of the lower esophagus and the lower esophagus sphincter. The lower esophagus sphincter, located between the esophagus and stomach, normally prevents reflux of acid and other stomach contents into the esophagus. In patients with Gastroesophageal Reflux (GERD), a weakened lower esophagus sphincter allows reflux of stomach acid into the esophagus, causing heart burn and acid damage to the esophagus (peptic esophagitis). Cisapride, like metoclopramide (Reglan), decreases stomach acid reflux by strengthening the lower esophagus sphincter, as well as the peristaltic muscle contractions of the lower esophagus. These two medications also hasten the stomach emptying of solid and liquid meals into the intestines. Faster emptying of meals decrease the reflux of stomach acid and other contents into the esophagus.

While cisapride and Reglan are similar in decreasing gastroesophageal reflux, Reglan is more likely to cause nervous system side effects such as jitteriness, insomnia, sedation, or anxiety.

PRESCRIPTION: yes

GENERIC AVAILABLE: no

PREPARATIONS: tablets: 10mg and 20mg

STORAGE: Tablets should be kept in a tight container and protected from light and moisture. Temperature should be kept between 15-30C (59-86F).

PRESCRIBED FOR: Cisapride is used for patients with heartburn and esophagitis due to gastroesophageal reflux. For further information, please read the GERD article.

DOSING: Cisapride is given four times daily, 15 minutes before each meal and at bedtime. Anticholinergic medications can decrease the beneficial effect of cisapride.

DRUG INTERACTIONS: Cisapride should be avoided in patients suffering from intestinal obstruction or perforation. Since cisapride accelerates stomach emptying, it can increase absorption and effects of other medications. For example, the effects of sedatives such as alcohol and diazepam (Valium) can be accelerated when used together with cisapride. Oral anticoagulant (Coumadin) may have increased effects in some patients also taking cisapride. The coagulation times (protimes) may need to be closely monitored to avoid excessive anticoagulation and risks of bleeding. Safety in children has not been established.

PREGNANCY: Safety in pregnancy has not been established.

NURSING MOTHERS: Safety in nursing mothers has not been established.

SIDE EFFECTS: Cisapride is generally well tolerated. The most common side affects include headache, diarrhea, nausea, abdominal pain, and constipation. Rarely, seizures, abnormal liver tests, fast heart rates have been reported. But the relationship of cisapride to these events were not clear.

Reference: FDA Prescribing Information

Last Editorial Review: 3/27/2000

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