Product Information
Registration Status: ActiveRESOLOR FILM-COATED TABLET 2mg is approved to be sold in Singapore with effective from 2012-02-14. It is marketed by JOHNSON & JOHNSON PTE LTD, with the registration number of SIN14104P.
This product contains Prucalopride 2mg in the form of TABLET, FILM-COATED. It is approved for ORAL use.
This product is manufactured by Janssen Cilag S.p.A. in ITALY.
It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.
Description
Prucalopride (brand name Resolor, developed by Johnson & Johnson and licensed to Movetis) is a drug acting as a selective, high affinity 5-HT4 receptor agonist which targets the impaired motility associated with chronic constipation, thus normalising bowel movements. Prucalopride was approved for use in Europe in 2009 and in Canada (named Resotran) on December 7, 2011 but it has not been approved by the Food and Drug Administration for use in the United States. The drug has also been tested for the treatment of chronic intestinal pseudo-obstruction.
Indication
Investigated for use/treatment in constipation, ileus, and pediatric indications.
Mechanism of Action
Prucalopride (PRU) is a selective high affinity 5-HT4 agonist, which are involved in initiating peristalsis. Prucalopride alters colonic motility patterns via serotonin 5-HT4 receptor stimulation: it stimulates colonic mass movements, which provide the main propulsive force for defecation.
Pharmacokinetics
- Absorption
- Prucalopride is rapidly absorbed (Cmax attained 2–3 hours after single 2 mg oral dose) and is extensively distributed.
- Distribution
- Metabolism
- In vitro, human liver metabolism is very slow and only minor amounts of metabolites are found.
- Elimination
Active Ingredient/Synonyms
Prucalopride | Prucalopride |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.