Prucalopride Dosage and Treatment Protocol for Chronic Idiopathic Constipation
The recommended dosage of prucalopride for adults with chronic idiopathic constipation is 2 mg once daily for those with normal renal function, and 1 mg once daily for patients with severe renal impairment (creatinine clearance <30 mL/min). 1, 2
Dosing Guidelines
- Prucalopride tablets can be taken with or without food 2
- Standard adult dose: 2 mg orally once daily 3, 2
- Dose for severe renal impairment (CrCl <30 mL/min): 1 mg once daily 3, 2
- No dose adjustment needed based on age - efficacy in elderly patients (≥65 years) is comparable to the overall adult population 3, 4
Treatment Protocol
- Prucalopride is strongly recommended by the American Gastroenterological Association and American College of Gastroenterology for the treatment of chronic idiopathic constipation 3
- Evaluate response after 4 weeks of treatment 1
- Clinical trials demonstrated sustained efficacy over 12 weeks 4, 5
- The 4 mg dose has been studied but offers no additional benefit over the 2 mg dose for most patients 6, 7
Mechanism of Action and Efficacy
- Prucalopride is a selective, high-affinity serotonin 5-HT4 receptor agonist that promotes colonic motility 1, 2
- It stimulates colonic high-amplitude propagated contractions, which help move colonic contents 3
- Clinical trials show significant increases in complete spontaneous bowel movements (CSBMs) per week compared to placebo 3, 1
- Responder rates (≥3 CSBMs per week) are significantly higher with prucalopride compared to placebo 1, 4
- Prucalopride directly stimulates colonic motility, differentiating it from other medications approved for chronic constipation 5
Side Effects and Monitoring
- Most common side effects include headache, abdominal pain, nausea, and diarrhea 2
- Side effects typically occur during the first week of treatment and resolve within a few days 3, 1
- Diarrhea leading to treatment discontinuation may be higher with prucalopride compared to placebo 3
- Monitor patients for unusual changes in mood, behavior, or suicidal ideation 2
- Cardiovascular adverse events were not more common than placebo in clinical trials 3, 5
Contraindications
- Hypersensitivity to prucalopride 2
- Intestinal perforation or obstruction due to structural or functional disorder of the gut wall 2
- Obstructive ileus 2
- Severe inflammatory conditions of the intestinal tract such as Crohn's disease, ulcerative colitis, and toxic megacolon/megarectum 3, 2
Clinical Pearls
- Unlike some older 5-HT4 agonists (such as cisapride and tegaserod), prucalopride does not interact with cardiac hERG potassium channels or other serotonergic receptors in blood vessels 5
- Warn patients about potential initial side effects (headache, nausea) that typically resolve within days 3, 1
- Prucalopride has shown efficacy regardless of age, BMI, and renal function, though the effect may be less pronounced in obese patients and those with moderate renal impairment 4
- Prucalopride improves not only stool frequency but also constipation symptoms, abdominal symptoms, quality of life, and treatment satisfaction compared to placebo 3, 8