Prucalopride Dosing for Chronic Constipation
The recommended dosing for prucalopride (Resolor/Motegrity) is 2 mg once daily for adults with chronic idiopathic constipation, with a reduced dose of 1 mg once daily for patients with severe renal impairment (creatinine clearance <30 mL/min). 1, 2, 3
Standard Dosing Protocol
- Standard adult dose: 2 mg once daily 1, 2, 3
- Renal impairment dose: 1 mg once daily for patients with severe renal impairment (CrCL <30 mL/min) 1, 2, 3
- Administration: Can be taken with or without food 3
- Timing: No specific time of day requirement; consistent daily dosing recommended
Efficacy and Clinical Considerations
Prucalopride is a selective, high-affinity serotonin 5-HT4 receptor agonist that promotes:
- Neurotransmission by enteric neurons
- Stimulation of the peristaltic reflex
- Enhanced intestinal secretions
- Improved GI motility 1, 2
The efficacy of prucalopride has been well-established in clinical trials:
- Increases complete spontaneous bowel movements (CSBMs) per week by 0.96 compared to placebo 1
- Produces higher responder rates (≥3 CSBMs per week) compared to placebo (RR 2.37) 1
- Efficacy is maintained throughout the 12-week treatment period 4, 5, 6
Patient Selection and Monitoring
Prucalopride is indicated for:
- Adults with chronic idiopathic constipation who have not responded adequately to over-the-counter laxatives 1, 2
- Patients across different age groups, with similar efficacy observed in patients ≥65 years compared to younger adults 1, 7
Prucalopride is contraindicated in patients with:
- Hypersensitivity to prucalopride
- Intestinal perforation or obstruction
- Severe inflammatory conditions of the intestinal tract (Crohn's disease, ulcerative colitis)
- Toxic megacolon/megarectum 1, 3
Adverse Effects and Safety Monitoring
Common adverse effects (occurring in ≥2% of patients):
Most side effects:
- Occur within the first week of treatment
- Typically resolve within a few days 1, 2
- Lead to discontinuation in approximately 5% of patients 1
Important Safety Considerations
- Psychiatric monitoring: Monitor patients for suicidal ideation, behavior, and mood changes 2, 3
- Discontinuation criteria: Discontinue immediately if patients experience unusual mood changes or suicidal thoughts 2, 3
- Cardiovascular safety: No increased risk of cardiovascular adverse events compared to placebo has been observed 1
Duration of Treatment
- Clinical trials evaluated prucalopride for 4-24 weeks 1
- The drug label does not specify a maximum treatment duration 1
- Long-term safety and efficacy data beyond 12 weeks are more limited 1, 8
Special Populations
- Elderly patients: No dose adjustment required; efficacy similar to overall population 1, 7
- Renal impairment: Reduce dose to 1 mg once daily in severe renal impairment 1, 2, 3, 7
- BMI considerations: Efficacy demonstrated across different BMI categories, although response may be lower in obese patients 7
Prucalopride offers an effective treatment option for chronic constipation with a rapid onset of action and sustained efficacy, particularly for patients who have failed to respond adequately to conventional laxative therapy.