Prucalopride Brand Name– MOTEGRITY
What is Prucalopride
Prucalopride is an oral selective serotonin (5HT-4) receptor agonist with enterokinetic properties.
Prucalopride is approved for the treatment of chronic idiopathic constipation (CIC) in adults. The efficacy of once-daily treatment with prucalopride was evaluated in 6 double-blind, placebo-controlled, randomized, multicenter clinical studies lasting 12 weeks (5 studies) or 24 weeks (1 study).
During studies, significantly more patients taking prucalopride (2 mg/day or less) achieved the primary efficacy endpoint of an average of 3 or more spontaneous complete bowel movements per week than with placebo (19% to 38% prucalopride vs. 10% to 20% placebo) across 5 of 6 trials.
A rapid response was seen with prucalopride as early as week 1, with improvements maintained throughout 12 weeks of treatment.
While a causal association has not been established, monitor treated patients for depressed mood or suicidal thoughts or behaviors during use as these have been reported during clinical studies.
In clinical studies, prucalopride did not demonstrate an increased risk of potential major adverse cardiovascular events (MACE) compared to placebo.
Prucalopride was FDA-approved in December 2018.
Indications
- constipation
For the treatment of chronic idiopathic constipation (CIC)
Side Effects
- abdominal pain
- anorexia
- depression
- diarrhea
- dizziness
- dyspnea
- edema
- fatigue
- flatulence
- headache
- increased urinary frequency
- migraine
- nausea
- pruritus
- rash
- suicidal ideation
- urticaria
- vomiting
Hypersensitivity reactions including dyspnea, rash (unspecified), pruritus, urticaria, and facial edema have been observed with prucalopride.
Monitoring Parameters
- laboratory monitoring not necessary
Contraindications
- breast-feeding
- children
- Crohn’s disease
- depression
- dialysis
- diverticulitis
- geriatric
- GI obstruction
- GI perforation
- ileus
- infants
- inflammatory bowel disease
- neonates
- pregnancy
- renal failure
- renal impairment
- suicidal ideation
- toxic megacolon
- ulcerative colitis
Interactions
- Fosfomycin
Fosfomycin: (Moderate) Prucalopride may decrease the systemic absorption of fosfomycin due to the prokinetic action of prucalopride. This may result in lower fosfomycin serum concentrations and urinary excretion. Monitor for evidence of clinical effectiveness of fosfomycin. Since fosfomycin is given as a single dose, separating times of administration may limit the interaction.
