Racecadotril


Generic Medicine Info
Indications and Dosage
Oral
Acute diarrhoea
Adult: As cap: Initially, 100 mg to be taken regardless of the time of the day, then 100 mg tid. Continue treatment until 2 normal stools are recorded. Max duration of treatment: 7 days. Dosage recommendations may vary among countries and individual products (refer to specific product guidelines).
Child: In combination with oral rehydration: As granules/powder for oral susp: Recommended dose: 1.5 mg/kg tid. Max: Approx 6 mg/kg daily. Usual doses: Infants (>3 months) <9 kg: 10 mg; 9-<13 kg: 20 mg; Children 13-27 kg: 30 mg; >27 kg: 60 mg. All doses to be taken tid. Continue treatment until 2 normal stools are recorded. Max duration of treatment: 7 days. Dosage recommendations may vary among countries and individual products (refer to specific product guidelines).
Administration
cap: May be taken with or without food. Swallow whole, do not open/break/chew. Administer initial cap at any time of the day. Subsequent cap, preferably taken prior to meals.
granules/powder for oral susp: May be taken with or without food. May be added to food or dispersed in a glass of water or in the feeding bottle. Mix well & take immediately after prep. Powder may be administered directly into mouth.
Contraindications
Diarrhoea associated with fever and/or bloody or purulent stools; antibiotic-associated diarrhoea. Patients who have experienced angioedema with ACE inhibitors.
Special Precautions
Patient with history of angioedema of any other aetiology. Administer racecadotril in combination with rehydration therapy. Avoid use in case of prolonged vomiting. Concomitant use with ACE inhibitors. Renal and hepatic impairment; avoid use in children with hepatic or renal impairment. Infants and children.
Adverse Reactions
Significant: Hypersensitivity or angioedema.
Nervous system disorders: Headache.
Respiratory, thoracic and mediastinal disorders: Tonsillitis (particularly in infants or children).
Skin and subcutaneous tissue disorders: Rash, erythema nodosum, erythema multiforme, urticaria, papular rash, prurigo, pruritus.
Potentially Fatal: Rarely, severe skin reactions.
Drug Interactions
May increase the risk of angioedema with ACE inhibitors (e.g. captopril, enalapril).
Food Interaction
Delayed peak activity by 1-1.5 hours when given with food.
Action
Description: Racecadotril is a prodrug of thiorphan, which is an inhibitor of enkephalinase, a cell membrane peptidase enzyme that aids in the hydrolysis of exogenous peptides and the breakdown of endogenous peptides (e.g. enkephalins). Inhibition of enkephalinase enzymatic degradation prolongs peptide action at enkephalinergic synapses in the small intestine and decreases hypersecretion without affecting basal secretion.
Duration: Enkephalinase inhibition: Approx 8 hours.
Pharmacokinetics:
Absorption: Rapidly absorbed. Delayed time to peak activity by 1-1.5 hours with food.
Distribution: Plasma protein binding: 90%, mainly to albumin (thiorphan).
Metabolism: Rapidly hydrolysed to thiorphan glycine (active metabolite), which is further metabolised to inactive metabolites.
Excretion: Mainly via urine (81.4%); faeces (approx 8%); as active and inactive metabolites. Elimination half-life: Approx 3 hours (racecadotril).
Chemical Structure

Chemical Structure Image
Racecadotril

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 107751, Racecadotril. https://pubchem.ncbi.nlm.nih.gov/compound/Racecadotril. Accessed May 26, 2022.

Storage
Store below 30°C.
MIMS Class
Antidiarrheals
ATC Classification
A07XA04 - racecadotril ; Belongs to the class of other antidiarrheals.
References
Anon. Racecadotril. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 06/04/2022.

Buckingham R (ed). Racecadotril. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 06/04/2022.

Hidrasec 100 mg Hard Capsules (Abbot Laboratories [M] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 06/04/2022.

Hidrasec 100 mg Hard Capsules (Bioprojet Europe Ltd.). MHRA. https://products.mhra.gov.uk. Accessed 06/04/2022.

Hidrasec Infants 10 mg Granules for Oral Suspension; Hidrasec Children 30 mg Granules for Oral Suspension (Abbot Laboratories [M] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 06/04/2022.

Hidrasec Infants 10 mg, Granules for Oral Suspension (Bioprojet Europe Ltd.). MHRA. https://products.mhra.gov.uk. Accessed 06/04/2022.

Hidrasec Paediatric 10 mg; Hidrasec Paediatric 30 mg (Abbott Laboratories Ltd.). MIMS Thailand. http://www.mims.com/thailand. Accessed 06/04/2022.

Rasec 30 mg/Sachet Powder for Oral Suspension (The Cathay Drug Co., Inc.). MIMS Philippines. http://www.mims.com/philippines. Accessed 06/04/2022.

Vaprino 100 mg Capsules, Hard (Opella Healthcare UK Limited, trading as Sanofi). MHRA. https://products.mhra.gov.uk. Accessed 06/04/2022.

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 © 2022 MIMS. All rights reserved. Powered by MIMS.com
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