Acute diarrhoea

Active Ingredient: Racecadotril

Indication for Racecadotril

Population group: only infants (40 days - 1 year old) , children (1 year - 12 years old)

Complementary symptomatic treatment of acute diarrhoea in infants (older than 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.

For this indication, competent medicine agencies globally authorize below treatments:

4.5 mg/kg in 3 divided doses daily

Route of admnistration


Defined daily dose

4.5 - 4.5 mg per kg of body weight

Dosage regimen

From 1.5 To 1.5 mg per kg of body weight 3 time(s) per day every day

Detailed description

The recommended dose is determined according to body weight: 1.5 mg/kg per dose three times daily at regular intervals.

In infant less than 9 kg: 10 mg 3 times daily.

In infant from 9 kg to 13 kg: 20 mg 3 times daily.

The duration of treatment in the clinical trials with children was 5 days. Treatment should be continued until two normal stools are recorded. Treatment should not exceed 7 days.

There are no clinical trials in infants fewer than 3 months of age.

Active ingredient


Racecadotril is a pure intestinal antisecretory active substance. It decreases the intestinal hypersecretion of water and electrolytes induced by the cholera toxin or inflammation, and does not have effects on basal secretory activity. Racecadotril exerts rapid antidiarrhoeal action, without modifying the duration of intestinal transit.

Read more about Racecadotril

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