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 Hidrasec summaries of product characteristics for infants and children).

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 complementary symptomatic treatment of acute diarrhoea in infants (aged over 3 months) and in children together with oral rehydration and the usual support measures (dietary advice and increased daily fluid intake [Abbott Healthcare Products Limited: personal communication January 2013]), 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).

Racecadotril is also licensed for the symptomatic treatment of acute diarrhoea in adults (see the summary of product characteristics for more information). The evidence to support its use in adults is discussed in a separate evidence summary.

Course and cost

Racecadotril granules for oral suspension can be added to food or dispersed in water. The manufacturer does not advise dispersion in large amounts of water (a teaspoonful is sufficient) because this may prove problematic in infants and children and dissolving in large volumes may render it bitter (Abbott Healthcare Products Limited: personal communication January 2013).

The recommended dose is 1.5 mg/kg per dose (corresponding to 1 or 2 sachets per dose), 3 times daily at regular intervals. Racecadotril 10 mg sachets are intended for children who weigh less than 13 kg, and 30 mg sachets are intended for children who weigh 13 kg or more. Table 1 shows the recommended dosing regimen.

Table 1 Dosing regimen for racecadotril in infants (aged over 3 months) and children

Weight

Less than 9 kg

9 kg to less than 13 kg

13 to 27 kg

More than 27 kg

Dose (3 times a day)

10 mg

20 mg

30 mg

60 mg

Sachets per dose

1x10 mg

2x10 mg

1x30 mg

2x30 mg

Treatment should be continued until 2 normal stools are recorded and should not exceed 7 days.

The current NHS cost of racecadotril 10 mg and 30 mg is £8.42 for a pack containing 20 sachets (excluding VAT; costs taken from MIMS, February 2013). The cost of treatment depends on the weight of the child and the duration of illness.