Cisapride is indicated for the symptomatic treatment of adult patients with nocturnal heartburn due to gastroesophageal reflux disease. Because of the risk of serious, and sometimes fatal, ventricular arrhythmias (see BOXED WARNING), cisapride should generally be reserved for patients who do not respond adequately to lifestyle modifications (see PRECAUTIONS, Information for the Patient and PATIENT PACKAGE INSERT), antacids and gastric acid reducing agents.

5 ml (1 teaspoon) suspension = 5 mg.

Adults

Initiate therapy with one 10 mg tablet of cisapride or 10 ml of the suspension 4 times daily at least 15 minutes before meals and at bedtime. In some patients the dosage will need to be increased to 20 mg, given as above, to obtain a satisfactory result.

Cisapride should be discontinued if relief of nocturnal heartburn does not occur. The minimum effective dose should be used. Recommended doses of cisapride should not be exceeded.

It is recommended that the daily dose be halved in patients with hepatic insufficiency.

In elderly patients, steady-state plasma levels are generally higher due to a moderate prolongation of the elimination half-life. Therapeutic doses, however, are similar to those used in younger adults.

Propulsid tablets are provided as scored white tablets debossed "Janssen" and "P/10" containing the equivalent of 10 mg of cisapride. Propulsid is also provided as blue tablets, debossed "Janssen" and "P/20", containing the equivalent of 20 mg cisapride.

Propulsid suspension is provided as a bright pink homogeneous suspension containing the equivalent of 1 mg/ml of cisapride.

Unit of use bottles should be dispensed as an intact unit. The PATIENT PACKAGE INSERT should be dispensed with the product.

Storage: Store at 15-25°C (59-77°F). Protect the tablets from moisture. The 20 mg tablets should also be protected from light.

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