Active Ingredient: Racecadotril
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:
Oral
4.5 - 4.5 mg per kg of body weight
From 1.5 To 1.5 mg per kg of body weight 3 time(s) per day every day
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.
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