cisapride (Rx)

Brand and Other Names:Propulsid
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

Available through investigational limited access program

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Gastrointestinal Dysmotility

5-10 mg PO q6hr at least 15 minutes PC and HS

May need to increase to 20 mg in some patients

Dosage Forms & Strengths

Available through investigational limited access program

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Gastrointestinal Dysmotility

0.15-0.3 mg/kg/dose PO q6-8hr; not to exceed 10 mg/dose 

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Interactions

Interaction Checker

and cisapride

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Headache

            Diarrhea

            1-10%

            Abdominal pain

            Constipation

            Tachycardia

            Rash

            Somnolence

            Fatigue

            Anxiety

            Insomnia

            Extrapyramidal effects

            Nausea

            Sinusitis

            Rhinitis

            Upper respiratory tract infection

            Increased incidence of viral infection

            <1%

            Bronchospasm

            Gynecomastia

            Hyperprolactenemia

            Methemoglobinemia

            Seizure

            Psychiatric disturbances

            Apnea

            Posmarketing Surveillance

            Serious cardiac arrhythmias including ventricular tachycardia, ventricular fibrillation, torsades de pointes, and QT prolongation reported primarily in patients with known risk factors

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            Warnings

            Black Box Warnings

            Cardiovascular: Serious cardiac arrhythmias including ventricular tachycardia, ventricular fibrillation, torsades de pointes, and QT prolongation; risk factors include concurrent therapy with drugs known to cause QT prolongation or depletion of serum electrolytes

            Drug Interactions: Contraindicated with numerous drugs including those known to cause QT prolongation (eg, tricyclics, certain antipsychotics) or CYP450 3A4 inhibitors (eg, fluconazole, ketoconazole, itraconazole); see list of disallowed medications at www.propulsid-lap.com

            Do not exceed recommended doses

            Available only via a limited access program for patients meeting requirements; 222.propulsid-lap.com

            Monitoring

            • Perform baseline 12-lead ECG
            • Do not initiate therapy if QTc >450 msec
            • Assess serum electrolyte and creatinine levels before initiating and whenever condition develops affecting electrolyte balance or renal function
            • Discontinue drug if syncope, tachycardia, or arrhythmia develops

            Contraindications

            Hypersensitivity

            Serious cardiac arrhythmias (eg, ventricular fibrillation, torsades de pointes, and QT prolongation) reported in patients taking cisapride with other drugs that inhibit cytochrome CYP3A4 or have additive QT prolonging effect; some of these events have been fatal

            Patient history or family history of prolonged QT syndrome

            History of renal failure, ventricular arrhythmias, ischemic heart disease, CHF, clinically significant bradycardia, uncorrected electrolyte disorders (eg, hypomagnesemia, hypokalemia), and respiratory failure

            Concomitant drugs known to prolong QT and increase risk of arrhythmia (eg, class III antiarrhymic agents, CYP3A4 inhibitors by elevating cisapride drug levels, drugs that decrease serum levels of potassium or magnesium)

            Upon requesting cisapride through the compassionate use program, a lenthy list of disallowed medications must be reviewed to assure the patient is not taking drugs that may result in serious or life-threatening interactions

            Cautions

            Decrease dose by 50% with liver impairment

            Potential benefits should be weighed against risks prior to initiating therapy in patients that may develop prolongation of cardiac conduction intervals, especially QTc

            Serious cardiac arrhythmias, tachycardia, ventricular fibrillation, torsade de pointes, and QT prolongation reported in patients taking CYP3A4 inhibitors

            Not for use in patients that might experience rapid reduction of plasma potassium as those resulting from potassium wasting diuretics and/or insulin in acute settings

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            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: enters breast milk; use with caution (AAP Committee states compatible with nursing)

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Metabolism: hepatic P450 enzyme CYP3A4

            Mechanism of Action

            Promotes gastric emptying, increases lower esophageal sphincter tone and esophageal peristalsis

            Increases gastric motility and cardiac rate possibly by releasing acethylcholine at the myenteric plexus; may act at the serotonin-4 receptor

            Pharmacokinetics

            Onset of action: 0.5-1 hr

            Bioavailability: 35-40%

            Half-life: 6-12 hr

            Protein binding: 97.5-98%

            Metabolism: Liver

            Excretion: Urine and feces

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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