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Propulsid® (cisapride) Tablets and Suspension has active element of cisapride which is an oral gastrointestinal agent. This active element as the monohydrate is a white to somewhat beige odorless powder. It is almost unsolvable in water, thinly solvable in methanol, and solvable in acetone. This drug is offered as tablets. The major inactive components in the tablets include colloidal silicon dioxide, magnesium stearate, lactose monohydrate, microcrystalline cellulose, povidone, polysorbate 20, and starch (corn).
Indication
Generic Propulsid is prescribed for treating gastric reflux (the regurgitation of stomach acid into the esophagus), which is typically experienced as heartburn. It also has other uses.
Contraindication
Cisapride is contraindicated in patients with heart failure; bleeding, or an obstruction in your stomach; kidney failure; heart disease or hardening of the arteries; irregular heartbeat; past record of prolonged QT intervals or congenital long QT syndrome; a structural heart defect; heart block or other conduction disturbances; severe dehydration (loss of water), malnutrition, vomiting, an eating disorder; severe lung problems or advanced cancer.
Dosage and Administration
Perform a 12-lead ECG before administration of Propulsid® (cisapride). It must not be used if the QTc value surpasses 450 milliseconds.
For adults, the recommended dose is one 10 mg tablet 4 times daily 15 minutes prior to meals and at bedtime. Otherwise the patient may take 10 mL of the suspension.
The dosage may be increased to 20 mg in some patients, to get a satisfactory result.
Use caution in geriatric patients. Before giving them this drug, it is essential to conduct a 12-lead ECG and serum electrolyte measurement. The elderly patients have usually elevated steady-state plasma levels because of a reasonable lengthening of the abolition half-life. Remedial doses, but, are close to dose of younger adults.
Patients with hepatic insufficiency should take half of the daily dose.
The doses should not be increased. Discontinue taking Propulsid® if nocturnal heartburn does not improve.
Side Effects
Some of the adverse events that were reported in a few Propulsid® patients were: dehydration, dizziness, pharyngitis, vomiting, chest pain, back pain, fatigue, depression, and myalgia.
A higher dose such as 20 mg of Propulsid® resulted in flatulence, diarrhea, constipation, abdominal pain, and rhinitis. Some of the more rare adverse effects caused by this drug were tremor, dry mouth, palpitation, somnolence, migraine, and edema.
Drug Abuse
Cisapride should not be taken with many drugs including: HIV drugs, antibiotics such as clarithromycin, troleandomycin (TAO), erythromycin, and sparfloxacin (Zagam); antifungal drugs such as itraconazole (Sporanox), fluconazole (Diflucan), and ketoconazole (Nizoral); some antidepressants; phenothiazines such as prochlorperazine and promethazine (Phenergan, others);heart medications or antihistamines and some blood pressure medicines.
Warnings
The hepatic cytochrome P450 3A4 isoenzyme is responsible for the metabolism of Propulsid® (cisapride). Medicines which restrain this enzyme can result in high cisapride blood levels.
Cisapride passes in to human milk. Hence it is advised to use this drug with caution in a nursing woman. In addition more special care is needed if the nursing child or the mother is taking a medicine that might change metabolism of the drug in the baby.
Safety and efficacy in children under the age of 16 years have not been recognized for any use.