Racecadotril Pediatric Dosing
The recommended dose of racecadotril for pediatric patients is 1.5 mg/kg administered orally every 8 hours (three times daily), given as adjunctive therapy to oral rehydration solution. 1, 2
Dosing Specifications
- Standard dose: 1.5 mg/kg per dose, given every 8 hours (TID) 1, 2
- Age range: Studied and used in children from 3 months to 5 years of age 1, 2, 3
- Duration: Continue until diarrhea resolves, typically 24-72 hours based on clinical trials 1, 4
Clinical Context and Efficacy
Racecadotril is an enkephalinase inhibitor with antisecretory properties that reduces intestinal fluid secretion without affecting motility 1. The evidence shows:
- Stool output reduction: Decreases 48-hour stool output by approximately 46-50% compared to placebo when added to oral rehydration therapy 1, 2
- Duration of diarrhea: Reduces median duration from 52-72 hours (placebo) to 28 hours (racecadotril) 1
- Oral rehydration needs: Significantly decreases the volume of oral rehydration solution required 1
Important Caveats
Racecadotril is NOT available in North America 5. This is a critical limitation mentioned in the 2017 IDSA guidelines on infectious diarrhea management 5.
While multiple RCTs demonstrate efficacy in reducing stool output and duration, a 2019 Cochrane review concluded that racecadotril has "little benefit" in improving acute diarrhea outcomes and does not support routine use outside of research settings 3. However, this contrasts with individual trial data showing significant clinical improvements 1, 2, 4, 6.
Safety Profile
- Adverse events: Well tolerated with no significant increase in adverse events compared to placebo (RR 0.90,95% CI 0.66-1.22) 3
- Side effects: When present, adverse effects are typically mild and transient 1
- No motility effects: Unlike loperamide, racecadotril does not affect intestinal motility, avoiding risks of ileus or toxic megacolon 1