Concise Prescribing Info
Acute diarrhoea.
Dosage/Direction for Use
Adult : PO 100 mg tid.  Continue treatment until 2 normal stools are recorded. Max duration of treatment: 7 days.
Dosage Details
Acute diarrhoea
Adult: 100 mg tid. Continue treatment until 2 normal stools are recorded. Max duration of treatment: 7 days.
Child: In combination with oral rehydration salts: Recommended dose: 1.5 mg/kg/dose tid.  Max dose: 6mg/kg daily. ≥3-9 months <9 kg: 10 mg tid. 9-30 months 9-13 kg: 20 mg tid. 30 months to 9 years 13-27 kg: 30 mg tid. >9 years >27 kg: 60 mg tid. Continue treatment until 2 normal stools are recorded. Max duration: 7 days.
May be taken with or without food.
Add granules to food, dispersed in a glass of water or in the feeding bottle, mix well and administer immediately.
Children with fructose intolerance, glucose malabsorption syndrome or sucrase-isomaltase deficiency (granules).
Special Precautions
Patient with history of angioedema. Children.
Adverse Reactions
Significant: Angioedema.
Respiratory, thoracic and mediastinal disorders: Tonsillitis.
Skin and subcutaneous tissue disorders: Rash, erythema, urticaria, erythema multiforme, nodular erythema, papular rash, prurigo, pruritus.
Potentially Fatal: Skin reactions.
Food Interaction
Food delays peak activity by approx 90 minutes.
Description: Racecadotril is a prodrug of thiorphan, an enkephalinase inhibitor. It achieves its antisecretory effect by protecting enkephalins from enzymatic degradation thereby prolonging their action at enkephalinergic synapses in the small intestine and reducing hypersecretion.
Duration: Approx 8 hours (enkephalinase inhibition).
Absorption: Rapidly absorbed. Time to peak plasma enkephalinase inhibition: Approx 2 hours.
Distribution: Plasma protein binding: 90% (mainly albumin).
Metabolism: Rapidly hydrolysed to thiorphan, the active metabolite, which is in turn transformed to inactive metabolites.
Excretion: Mainly via urine (81.4%), via faeces (approx 8%). Elimination half-life: Approx 3-4 hours.
Chemical Structure

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Store below 25°C.
MIMS Class
ATC Classification
A07XA04 - racecadotril ; Belongs to the class of other antidiarrheals.
Disclaimer: This information is independently developed by MIMS based on Racecadotril from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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