PRUCALOPRIDE TAB,ORAL
Clinical Criteria Summary
Exclusion Criteria
- Intestinal perforation or obstruction due to structural or functional disorder of the gut wall, obstructive ileus, severe inflammatory conditions of the GI tract (e.g., Crohn’s disease, ulcerative colitis, toxic megacolon / megarectum)
- Untreated or unstable depression or suicidality
- End-stage renal disease requiring dialysis
- Age less than 18 years
- Presence of severe or frequent diarrhea
Inclusion Criteria
- Men or women 18 years or older with chronic idiopathic constipation (CIC)
- Intolerance or inadequate response to a 1-month trial of at least one bulk forming laxative (e.g., psyllium, oxidized cellulose, calcium polycarbophil) with fluids, unless there is a contraindication or risk factor(s) for serious adverse event(s)
- Intolerance or inadequate response to a 1-month trial of either PEG-3350 powder for oral solution (17 g twice daily) or other osmotic laxative, unless there is a contraindication or risk factor(s) for serious adverse event(s)
- Intolerance or inadequate response to a 1-month trial of lubiprostone (24 mcg twice daily), unless there is a contraindication or risk factor(s) for serious adverse event(s)
Clinical Recommendations & Definitions
- Chronic idiopathic constipation (CIC) excludes drug-induced chronic constipation and chronic constipation due to neurogenic and non-neurogenic disorders.
- GI consultation is highly recommended to diagnose and evaluate CIC.