Racecadotril Pediatric Dosing
The recommended dose of racecadotril for pediatric patients with acute diarrhea is 1.5 mg/kg administered orally three times daily (every 8 hours) as adjunctive therapy to oral rehydration solution. 1, 2
Dosing Specifications
- Standard dose: 1.5 mg/kg per dose, given orally every 8 hours (three times daily) 1, 2
- Age range: Approved for use in children aged 3 months to 5 years 1, 2, 3
- Administration: Given in addition to standard oral rehydration therapy, not as monotherapy 1, 2
Important Context and Limitations
Availability and Guideline Position
- Racecadotril is NOT available in North America and therefore cannot be prescribed in the United States or Canada 4
- The Infectious Diseases Society of America (2017) acknowledges that racecadotril reduces stool volume but notes its unavailability in North America 4
- Current North American guidelines do not include racecadotril in treatment algorithms due to lack of availability 4
Evidence of Efficacy
- Clinical trials demonstrate racecadotril reduces stool output by approximately 46-50% in the first 48 hours compared to placebo 1, 2
- Duration of diarrhea is significantly shortened (median 28 hours with racecadotril vs 52-72 hours with placebo) 2
- Efficacy is consistent regardless of rotavirus status 1, 2
Safety Profile
- Racecadotril appears safe and well-tolerated in pediatric populations 1, 2, 3
- Adverse events are typically mild and transient when they occur 2
- No significant increase in overall adverse event rates compared to placebo (RR 0.90,95% CI 0.66 to 1.22) 3
Quality of Evidence Considerations
- A 2019 Cochrane review concluded that while racecadotril appears safe, it has little benefit in improving acute diarrhea in children under five years of age 3
- The Cochrane review specifically states: "Current evidence does not support routine use of racecadotril in management of acute diarrhea in children under five outside of the context of placebo controlled RCTs" 3
- The overall quality of evidence is limited due to sparse data, heterogeneity, and risk of bias in available studies 5
Clinical Bottom Line
If racecadotril is available in your region and you choose to use it, the dose is 1.5 mg/kg orally every 8 hours for children 3 months to 5 years of age, always given as adjunctive therapy with oral rehydration solution. 1, 2 However, be aware that the most recent systematic review questions its clinical benefit, it is unavailable in North America, and standard oral rehydration therapy remains the cornerstone of treatment for pediatric acute diarrhea. 4, 3