Can Racecadotril Be Given?
Yes, racecadotril can be given as an adjunctive treatment for acute watery diarrhea in children, though current evidence suggests limited clinical benefit and it should not be used routinely outside of controlled research settings.
Evidence for Use
Racecadotril is an oral enkephalinase inhibitor with antisecretory properties that prevents degradation of endogenous opioids (enkephalins), thereby reducing hypersecretion of water and electrolytes into the intestinal lumen 1.
Efficacy in Children
Stool output reduction: In hospitalized boys aged 3-35 months with acute watery diarrhea, racecadotril (1.5 mg/kg orally every 8 hours) plus oral rehydration therapy reduced 48-hour stool output by 46% compared to placebo (92 g/kg vs 170 g/kg, P<0.001) 2.
Duration of diarrhea: The median duration was significantly shorter with racecadotril (28 hours) compared to placebo (72 hours for rotavirus-positive patients, 52 hours for rotavirus-negative patients, P<0.001) 2.
Overall clinical benefit: However, a 2019 Cochrane systematic review of 7 RCTs with 1,140 children under 5 years concluded that racecadotril has little benefit in improving acute diarrhea and does not support routine use outside of placebo-controlled trials 3.
Efficacy in Adults
Racecadotril (100 mg three times daily) showed similar efficacy to loperamide in adults with acute diarrhea, with comparable duration of diarrhea (14.9 hours vs 13.7 hours) and number of stools before recovery 4.
The drug was effective in reducing stool weight and frequency in castor oil-induced diarrhea models 1.
Safety Profile
Tolerability: Racecadotril was well tolerated with only mild and transient adverse effects in pediatric studies 2.
Adverse events: Overall rate of adverse events was similar to placebo (RR 0.90,95% CI 0.66 to 1.22) 3.
Advantage over loperamide: Racecadotril caused significantly less rebound constipation after resolution of diarrhea compared to loperamide (9.8% vs 18.7%) 4.
Dosing
Children: 1.5 mg/kg orally every 8 hours as adjunct to oral rehydration therapy 2.
Adults: 100 mg orally three times daily 4.
Clinical Caveats
Limited guideline support: Racecadotril is mentioned in travelers' diarrhea guidelines as an antisecretory agent that has not been adequately evaluated in the relevant setting of travelers' diarrhea 5.
Questionable mechanism: Critical analysis questions the peripheral antisecretory selectivity and suggests more research is needed before reliable conclusions can be drawn on its place in diarrhea treatment 6.
Not first-line: Current evidence does not support routine use in management of acute diarrhea in children under 5 years outside of controlled trial settings 3.
Practical Recommendation
While racecadotril can be given and appears safe, prioritize oral rehydration therapy as the primary treatment for acute diarrhea. Consider racecadotril only as adjunctive therapy in settings where it is available and when standard rehydration measures need augmentation, recognizing that clinical benefit is modest at best 3.