A Drug Utilisation Study of Rifaximin 550mg

Date of Approval
Application Number
Technical Summary

Rifaximin- is an antibacterial drug which has been marketed for many years as a 200mg tablet for various gastrointestinal infections such as travellers' diarrhoea. In November 2012, Norgine received decentralised procedure approval for rifaximin- (XIFAXAN/TARGAXAN) 550mg. This is a prescription-only medication that is used in adults with liver disease to reduce the recurrence of episodes of overt Hepatic Encephalopathy (HE). In January 2013, the UK was the first to launch the 550mg product in Europe. A drug utilisation study will be conducted in CPRD GOLD, IMS Disease Analyser Germany and the HTI-CPRD GOLD link to understand the dosing, the formulation, the indications and the patient demographics associated with rifaximin- 550mg tablets across the UK and Germany following launch in January 2013. Tables of descriptive data (including counts, mean, median, standard deviation and inter-quartile range) on each patient cohort will be presented. The aim of this analysis it to address three regulatory concerns about the new drug, interactions with other treatments, potential off label use for other indications and potential off label paediatric use.

Health Outcomes to be Measured

Rifaximin- 550mg is the exposure of interest, for which there is one gemscript code available in CPRD.


Jennifer Campbell - Chief Investigator - CPRD
Jennifer Campbell - Corresponding Applicant - CPRD
Bharat Amlani - Collaborator - Norgine
Hanna Sodatonou - Collaborator - Norgine