prucalopride (Rx)

Brand and Other Names:Motegrity
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 1mg
  • 2mg

Chronic Idiopathic Constipation

Indicated for treatment of chronic idiopathic constipation (CIC)

2 mg PO qDay

Dosage Modifications

Renal impairment

  • Mild or moderate (CrCl ≥30 mL/min): No dosage adjustment necessary
  • Severe (CrCl<30 mL/min): 1 mg PO qDay
  • End-stage renal disease: Avoid use

Hepatic impairment

  • Moderate or severe (Child-Pugh B or C): After a single oral dose of 2 mg, peak plasma concentration and AUC averaged 10-20% higher than normal hepatic function; not clinically significant

Safety and efficacy not established

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Interactions

Interaction Checker

and prucalopride

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
             activity indicator 

            Contraindicated (0)

              Serious - Use Alternative (0)

                Monitor Closely (0)

                  Minor (0)

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                    Adverse Effects

                    >10%

                    Headache (19%)

                    Abdominal pain (16%)

                    Diarrhea (13%)

                    Nausea (14%)

                    1-10%

                    Abdominal distension (5%)

                    Dizziness (3%)

                    Vomiting (3%)

                    Flatulence (3%)

                    Fatigue (2%)

                    <2%

                    • Abnormal GI sounds
                    • Decreased appetite
                    • Migraine
                    • Pollakiuria

                    Postmarketing Reports

                    Hypersensitivity reactions: Dyspnea, rash, pruritus, urticaria, and facial edema

                    Psychiatric disorders: Suicide, suicide attempts, suicidal ideation, self-injurious ideation, depression, anxiety, insomnia, nightmares, and visual hallucinations

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                    Warnings

                    Contraindications

                    Hypersensitivity

                    Intestinal perforation or obstruction due to structural or functional disorder of gut wall, obstructive ileus, severe inflammatory conditions of the intestinal tract (eg, Crohn disease, ulcerative colitis, toxic megacolon/megarectum)

                    Cautions

                    Suicidal ideation and behavior

                    • In clinical trials, suicides, suicide attempts, and suicidal ideation reported
                    • A causal association between treatment and an increased risk of suicidal ideation and behavior not established
                    • Monitor for persistent worsening of depression or the emergence of suicidal thoughts and behaviors
                    • Instruct patients to discontinue immediately and contact their healthcare provider if they experience any of these symptoms
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                    Pregnancy

                    Pregnancy

                    Available data from case reports with use in pregnant women are insufficient to identify any drug-associated risks of miscarriage, major birth defects, or adverse maternal or fetal outcomes

                    A pregnancy exposure registry monitors pregnancy outcomes in women exposed to drug during pregnancy; healthcare providers are encouraged to register patients by contacting MotherToBaby Pregnancy Studies conducted by the Organization of Teratology Information Specialists (OTIS) at 1-877-311-8972 or visiting https://mothertobaby.org/pregnancy-studies/

                    Animal data

                    • In animal reproduction studies, no adverse developmental effects were observed with prucalopride during organogenesis in pregnant rats and rabbits at doses up to ~390x and 780x, respectively, the recommended human dose of 2 mg/day

                    Lactation

                    Prucalopride is present in breast milk

                    No data are available of effects on breastfed children or milk production

                    Consider developmental and health benefits of breastfeeding along with the mother’s clinical need and any potential adverse effects on the breastfed child from prucalopride or from the underlying maternal condition

                    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

                    Mechanism of Action

                    Selective serotonin type 4 (5-HT4) receptor agonist; elicits GI prokinetic actions that stimulates colonic peristalsis (high-amplitude propagating contractions [HAPCs]), which increases bowel motility

                    Absorption

                    Peak plasma time: 2-3 hr

                    Peak plasma concentration: 7 ng/mL

                    AUC = 109 ng·hr/mL

                    Steady-state achieved within 3-4 days

                    Bioavailability: >90%

                    Distribution

                    Vd (steady-state): 567 L (IV)

                    Protein bound: ~30%

                    Metabolism

                    CYP3A4 substrate in vitro

                    7 different known minor metabolites; O-desmethyl prucalopride acid (most common metabolite) represents 0-1.7% of total plasma exposure

                    Elimination

                    Half-life: 1 day

                    Clearance: 317 mL/min

                    Excretion (average): Urine (84.2%); feces (13.3%)

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                    Administration

                    Oral Administration

                    Take with or without food

                    Storage

                    Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F)

                    Keep in original container to protect from moisture

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                    Images

                    BRAND FORM. UNIT PRICE PILL IMAGE
                    Motegrity oral
                    -
                    1 mg tablet
                    Motegrity oral
                    -
                    2 mg tablet

                    Copyright © 2010 First DataBank, Inc.

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                    Patient Handout

                    A Patient Handout is not currently available for this monograph.
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                    Formulary

                    FormularyPatient Discounts

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

                    To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

                    Adding plans allows you to:

                    • View the formulary and any restrictions for each plan.
                    • Manage and view all your plans together – even plans in different states.
                    • Compare formulary status to other drugs in the same class.
                    • Access your plan list on any device – mobile or desktop.

                    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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                    Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.