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Propulsid (Cisapride) - Indications and Dosage

 
 



INDICATIONS AND USAGE

PROPULSID® (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), PROPULSID® should generally be reserved for patients who do not respond adequately to lifestyle modifications (See PRECAUTIONS: Information for Patients and Medication Guide), antacids and gastric acid reducing agents.

DOSAGE AND ADMINISTRATION

5 mL (1 teaspoon) suspension = 5 mg.

A 12-lead ECG should be performed prior to administration of PROPULSID® (cisapride). Treatment with PROPULSID® should not be initiated if the QTc value exceeds 450 milliseconds. Serum electrolytes (potassium, calcium, and magnesium) and creatinine should be assessed prior to administration of PROPULSID® and whenever conditions develop that may affect electrolyte balance or renal function.

Adults: Initiate therapy with one 10 mg tablet of PROPULSID® 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.

Caution must be exercised in elderly patients since there is a significant proportion who have conditions or use other drugs which contraindicate the use of PROPULSID®. A 12-lead ECG and serum electrolyte measurement should be performed prior to treatment with PROPULSID®. 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.

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

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

HOW SUPPLIED

PROPULSID® (cisapride) Tablets are provided as scored white tablets debossed "Janssen" and P/10 containing the equivalent of 10 mg of cisapride in blister packages of 100 (NDC 50458-430-01) and in unit of use bottles of 120 (NDC 50458-430-12). PROPULSID® is also provided as blue tablets, debossed "Janssen" and P/20, containing the equivalent of 20 mg cisapride in blister packages of 100 (NDC 50458-440-01) and in unit of use bottles of 60 (NDC 50458-440-06).

PROPULSID® Suspension is provided as a bright pink homogeneous suspension containing the equivalent of 1 mg/mL of cisapride in 16 oz. unit of use bottles containing 450 mL (NDC 50458-450-45).

Unit of use bottles should be dispensed as an intact unit. The Medication Guide should be dispensed with the product.

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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JANSSEN PHARMACEUTICA

Titusville, New Jersey 08560

7502617

U.S. Patent No. 4,962,115

Revised May 1999, January 2000

©JPPLP 2000

MEDICATION GUIDE

IMPORTANT: READ COMPLETELY BEFORE USE. Do not take PROPULSID® if you have a medical condition or take a drug listed in this Medication Guide in the section “Who Should Not Take PROPULSID®?”

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