Product overview

Drug action

Racecadotril is an intestinal antisecretory enkephalinase inhibitor that inhibits the degradation of endogenous enkephalins. It thereby reduces the hypersecretion of water and electrolytes into the intestine. Unlike antimotility drugs, it does not modify the duration of intestinal transit (see the summary of product characteristics).

Licensed therapeutic indication

Racecadotril received a UK marketing authorisation in September 2011 and was launched in the UK in October 2012. It has been licensed in parts of Europe for some time, for example in France for more than 20 years (Abbott Healthcare Products Limited: personal communication December 2012).

Racecadotril is licensed for the symptomatic treatment of acute diarrhoea in adults when causal treatment is not possible. If causal treatment is possible, racecadotril can be administered as a complementary treatment (see the Hidrasec summary of product characteristics).

Racecadotril is also licensed for the complementary symptomatic treatment of acute diarrhoea in infants (aged over 3 months) and in children together with oral rehydration and the usual support measures, when these measures alone are insufficient to control the clinical condition, and when causal treatment is not possible. If causal treatment is possible, racecadotril can be administered as a complementary treatment (see the summaries of product characteristics for infants and children). The evidence to support its use in children is discussed in a separate evidence summary.

Course and cost

One 100 mg capsule should be taken initially regardless of the time of day. Subsequently the dose is 1 capsule 3 times daily, preferably before main meals. Treatment should be continued until 2 normal stools are recorded and should not exceed 7 days (see the summary of product characteristics).

The current NHS cost of racecadotril 100 mg is £8.42 for a 20-capsule pack (excluding VAT; cost taken from MIMS, February 2013).