Racecadotril Dosing in Children
Racecadotril is dosed at 1.5 mg/kg orally three times daily (every 8 hours) in children aged 3 months and older with acute diarrhea, administered as adjunctive therapy to oral rehydration solution. 1, 2
Standard Dosing Protocol
- Administer 1.5 mg/kg orally every 8 hours (three times daily) for children 3 months to 5 years of age with acute watery diarrhea 1, 2
- Continue treatment until diarrhea resolves, typically within 28-72 hours based on clinical trials 2
- Always use racecadotril as an adjunct to oral rehydration therapy, never as monotherapy 1, 2
Clinical Context and Availability
- Racecadotril is NOT available in North America (United States and Canada), limiting its use to other regions where it is approved 3
- The drug reduces stool output by approximately 46-50% compared to placebo when added to oral rehydration therapy 1, 2
- It works as an enkephalinase inhibitor with antisecretory properties, reducing intestinal hypersecretion without affecting gut motility 2
Evidence Quality and Efficacy
The dosing recommendation of 1.5 mg/kg three times daily is based on multiple randomized controlled trials demonstrating:
- Significant reduction in 48-hour stool output (92 g/kg vs 170 g/kg with placebo, p<0.001) 2
- Shorter duration of diarrhea (median 28 hours vs 72 hours with placebo) 2
- Reduced need for oral rehydration solution intake 2
- Good tolerability with only mild, transient adverse effects 1, 2
However, a 2019 Cochrane systematic review concluded that racecadotril has little benefit in improving acute diarrhea outcomes and does not support routine use outside of research settings 4. This creates a discrepancy between older individual trials showing benefit and more recent comprehensive meta-analysis showing limited clinical impact.
Safety Profile
- Tolerability is comparable to placebo (10.4% vs 10.6% adverse event incidence) 5
- Adverse events when present are typically mild and transient 1, 2
- No serious safety concerns have been identified in pediatric populations 1, 2, 5
Important Caveats
- This medication is distinct from antimotility drugs like loperamide, which are absolutely contraindicated in all children under 18 years of age 3, 6
- Racecadotril works through antisecretory mechanisms rather than slowing gut motility, making it theoretically safer than loperamide 2
- Despite demonstrated reductions in stool output, the clinical significance remains debated given the Cochrane review findings 4
- Geographic availability severely limits practical application of this dosing information for North American practitioners 3