Dosing & Uses
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
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (0)
Monitor Closely (0)
Minor (0)
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
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
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.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%)
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
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Motegrity oral - | 2 mg tablet |  | |
| Motegrity oral - | 1 mg tablet |  |
Copyright © 2010 First DataBank, Inc.
Formulary
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