Motegrity® (Resotran® in Canada) is intended for adults in whom laxatives have failed to provide adequate relief.
Motegrity® (prucalopride 1 mg and 2 mg tablets) for the treatment of chronic idiopathic constipation in adult women. The drug is intended for women in whom OTC laxatives have failed to provide adequate relief. Prucalopride (brand name Resolor® or Resotran® in Canada) has been on the market in many European countries since mid to late 2009. There is approximately 2400 patient years study on this drug to date.
Motegrity® aka Resotran® is an enterokinetic agent. It acts as a serotonin 5HT4 receptor agonist to enhance the peristaltic reflex and propulsive motor patterns in the gastrointestinal tract. Prucalopride is the first dihydrobenzofurancarboxamide derivative. It differs structurally from other serotonergic prokinetic agents that were withdrawn from the market in Canada and/or the U.S., including cisapride (a substituted benzamide derivative) and tegaserod (an aminoguanidine indole derivative).
The usual dosage of Motegrity® is 2 mg once daily, with or without food. No dosage adjustment is required for mild to moderate renal or hepatic impairment. A 1 mg once-daily dosage is recommended in women > 65 years of age and women with severe renal or hepatic impairment. If a bowel movement does not occur within three to four days after starting therapy, treatment should continue, but consideration should be given to adding a laxative to treat acute constipation.
Motegrity® therapy should be discontinued if the drug is not effective after the first four weeks. Efficacy has been established in controlled trials for up to three months. If treatment is prolonged, patients should be reassessed periodically to ensure that they are still receiving benefit from the drug.
The most common adverse effects of prucalopride are nausea, diarrhea, abdominal pain and headache. These are generally mild to moderate in intensity and most frequent during the first two days of treatment. More serious possible adverse effects include a slight increase in heart rate and palpitations. The drug should be used with caution in patients with a history of arrhythmia or ischemic heart disease.
Severe diarrhea may occur, which can reduce the efficacy of oral contraceptives. Ischemic colitis is also a potential adverse effect; patients should be advised to contact a physician if they develop severe, persistent or worsening abdominal symptoms, bloody diarrhea or rectal bleeding. Motegrity® is not recommended during pregnancy or while breastfeeding, due to insufficient safety data.
- Janssen Inc. Resotran (prucalopride tablets) product monograph. Toronto, Ont.; December 2, 2011. 2. Frampton JE. Prucalopride. Drugs 2009;69:2463-76. 3