Motegrity (Prucalopride) Dosing for Chronic Idiopathic Constipation
The standard dose of Motegrity (prucalopride) is 2 mg orally once daily for adults with normal renal function, which can be taken with or without food. 1
Standard Dosing Regimen
- Adults with normal renal function should take 2 mg orally once daily as the target therapeutic dose. 2, 1
- The medication can be taken with or without food, providing flexibility in administration. 1
- The initial dose range is 1-2 mg daily, with 2 mg being the standard therapeutic dose for most patients. 2
Dose Adjustments for Special Populations
- Patients with severe renal impairment (creatinine clearance less than 30 mL/min) require dose reduction to 1 mg once daily. 1
- No dose adjustment is needed for patients with mild to moderate renal impairment (eGFR 30 to <90 mL/min/1.73 m²), as efficacy is maintained across these subgroups. 3
- The efficacy of prucalopride in elderly patients (65 years and older) is comparable to younger adults, with no dose adjustment required based on age alone. 3
Dose Titration and Maximum Dose
- The maximum approved dose is 2 mg daily—do not exceed this dose. 2, 1
- Titrate based on symptom response and tolerability, though most patients will remain on the standard 2 mg daily dose. 2
- There is no routine need for dose escalation beyond 2 mg, as higher doses (4 mg) have not demonstrated superior efficacy in clinical practice despite some research data. 4
Place in Therapy
- Prucalopride is a serotonin type 4 (5-HT4) receptor agonist that enhances colonic motility and should be reserved for refractory cases when over-the-counter laxatives (particularly polyethylene glycol) have failed. 5, 2
- Consider prucalopride after inadequate response to first-line osmotic laxatives and second-line stimulant laxatives, or as an alternative to other prescription secretagogues (lubiprostone, linaclotide, plecanatide). 5, 6
- The medication may provide additional benefit for abdominal pain beyond improving bowel frequency. 5, 2
Clinical Efficacy Timeline
- Significant differences from placebo are evident in week 1 and sustained thereafter, with early response (weeks 1-4) predicting ultimate response over time. 7
- Treatment duration in clinical trials was typically 12 weeks, but may be continued without a specified limit based on ongoing symptom control. 6
Common Side Effects
- The most common adverse reactions (≥2%) include headache, abdominal pain, nausea, diarrhea, abdominal distension, dizziness, vomiting, flatulence, and fatigue. 1
- Most adverse events are gastrointestinal symptoms and headache, typically mild to moderate in severity. 8
Critical Safety Warning
- Monitor patients for suicidal ideation and behavior, as well as self-injurious ideation and new-onset or worsening depression. 1
- Instruct patients to discontinue prucalopride immediately and contact their healthcare provider if they experience any unusual changes in mood or behavior, or emerging suicidal thoughts. 1
Contraindications
- Do not use in patients with hypersensitivity to prucalopride, intestinal perforation or obstruction, obstructive ileus, or severe inflammatory conditions such as Crohn's disease, ulcerative colitis, or toxic megacolon. 1
Cost Considerations
- The estimated monthly cost is approximately $563, making it significantly more expensive than first-line osmotic laxatives, which should factor into treatment decisions. 2