Racecadotril is indicated for the symptomatic treatment of acute diarrhea.
Racecadotril is a prodrug that needs to be hydrolysed to its active metabolite thiorphan. Thiorphan is an inhibitor of enkephalinase. Enkephalinase is a cell membrane peptidase located in various tissues, notably in the epithelium of the small intestine. This enzyme hydrolyses or breaks down the exogenous peptides and endogenous peptides (enkephalins). Racecadotril protects enkephalins from enzymatic degradation thereby prolonging their action at enkephalinergic synapses in the small intestine and reducing water and electrolytes hypersecretion. Racecadotril exerts rapid antidiarrheal action, without modifying the duration of intestinal transit. Racecadotril does not produce abdominal distension.
Adults: One capsule initially, regardless of the time of day. Then one capsule three times daily preferably before the main meals. Children (from 3 months of age): Racecadotril granules should be administered together with oral rehydration. The recommended dose is determined according to body weight: 1.5 mg/kg per administration, three times daily. Infants less than 9 kg: one 10 mg sachet 3 times daily. Infants from 9 kg to 13 kg: two 10 mg sachets 3 times daily. Children from 13 kg to 27 kg: one 30mg sachet 3 times daily. Children of more than 27 kg: two 30mg sachets 3 times daily.
No interactions with other active substances have been described in humans to date. In humans, joint treatment with Racecadotril and Loperamide or Nifuroxazide does not modify the kinetics of Racecadotril.
Hypersensitivity to Racecadotril, or to any of the excipients. The administration of Racecadotril does not modify the usual rehydration regimens. The presence of bloody stools and fever may indicate the presence of invasive bacteria as a reason for diarrhea or the presence of other severe disease. Racecadotril has not been tested in antibiotic-associated diarrhea and should therefore not be administered under these conditions. Caution should be taken in patients with renal or liver impairment.
Headache, erythema multiforme, urticaria, angioedema may be seen.
Due to a lack of clinical data, Racecadotril should not be administered to pregnant or breastfeeding women.
No cases of overdose have been reported. In adults, single doses above 2 g which is equivalent to 20 times the therapeutic dose, have been administered, and no harmful effects have been described.
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
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