Racecadotril Pediatric Dosing
The recommended dose of racecadotril for children is 1.5 mg/kg administered orally every 8 hours (three times daily) as an adjunct to oral rehydration therapy. 1, 2
Dosing Specifications
- Standard dose: 1.5 mg/kg per dose given every 8 hours 1, 2, 3
- Frequency: Three times daily (every 8 hours) 1, 2
- Route: Oral administration 1, 2
- Age range studied: 3 months to 5 years 1, 2, 4
Administration Guidelines
- Always combine with oral rehydration solution (ORS) - racecadotril is used as adjuvant therapy, not monotherapy 1, 2, 5
- The drug can be administered with both oral and intravenous rehydration protocols 3
- Treatment should be initiated as soon as acute watery diarrhea is diagnosed 1, 2
Expected Clinical Effects
- Stool output reduction: 46-50% reduction in stool output within the first 48 hours compared to ORS alone 1, 2
- Duration of diarrhea: Median duration reduced to approximately 28 hours (versus 52-72 hours with placebo) 1
- ORS requirements: Significantly lower fluid intake needed when racecadotril is added 1
Safety Profile
- Adverse events are mild and transient when they occur 1
- No serious adverse events have been reported in pediatric studies 5
- The drug does not affect intestinal motility, only reduces water and electrolyte secretion 5
- Overall adverse event rate is similar to placebo (RR 0.90,95% CI 0.66 to 1.22) 4
Important Clinical Context
While racecadotril demonstrates statistically significant reductions in stool output and diarrhea duration in individual trials 1, 2, 3, a 2019 Cochrane systematic review concluded that current evidence does not support routine use outside of research settings due to limited overall clinical benefit 4. However, the drug appears safe and may be considered in settings where it is available and approved for use 5.