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Administration
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.
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. |
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Contraindications
Diarrhoea associated with fever and/or bloody or purulent stools; antibiotic-associated diarrhoea. Patients who have experienced angioedema with ACE inhibitors.
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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.
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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. |
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Drug Interactions
May increase the risk of angioedema with ACE inhibitors (e.g. captopril, enalapril).
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CIMS Class
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ATC Classification
A07XA04 - racecadotril ; Belongs to the class of other antidiarrheals.
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