What is the recommended racecadotril (acetorphan) dose for acute diarrhoea according to age?

Racecadotril Dosing by Age for Acute Diarrhea

Racecadotril should be dosed at 1.5 mg/kg orally three times daily (every 8 hours) for children aged 3 months and older, administered as adjunctive therapy to oral rehydration solution, though it is not available in North America and provides only modest clinical benefit beyond rehydration alone. 1, 2, 3, 4

Age-Specific Dosing

Infants and Children (≥3 months to <5 years)

• Dose: 1.5 mg/kg orally every 8 hours (three times daily) 3, 4, 5
• This dosing has been validated in multiple trials involving children aged 3 months to 5 years 3, 6, 4, 5
• The medication should only be initiated after adequate hydration is established with oral rehydration solution 2, 4

Adults

• Racecadotril has demonstrated efficacy in reducing stool volume in adults with acute diarrhea, though specific adult dosing is not detailed in pediatric-focused guidelines 1, 2
• The drug should only be considered after adequate hydration is achieved 2

Critical Geographic Limitation

• Racecadotril is NOT available in North America (United States and Canada), severely limiting its practical application in these regions 1, 2
• The drug is available in Europe, Latin America, and parts of Asia where the studies were conducted 3, 6, 4, 5

Clinical Context and Efficacy

When to Consider Racecadotril

• Only use racecadotril in acute watery (non-inflammatory) diarrhea 2, 4
• The patient must be ≥3 months of age 2, 3, 4
• Adequate oral rehydration must be initiated first—racecadotril is strictly an adjunct, not primary therapy 2, 3, 4
• The drug must be available in your geographic region 2

When NOT to Use Racecadotril

• Never use in inflammatory diarrhea (bloody stools, fever, systemic toxicity) 2
• Do not use before establishing adequate hydration 2
• Not applicable in North America where unavailable 1, 2
• Avoid in children <3 months of age (no safety data) 3, 4

Evidence Quality and Clinical Impact

Demonstrated Benefits

• Racecadotril reduces 48-hour stool output by approximately 46-50% compared to placebo when added to oral rehydration therapy 3, 4
• Duration of diarrhea may be shortened by approximately 28 hours (from 106.2 hours to 78.2 hours) 5
• The drug appears safe with adverse event rates similar to placebo (10.4% vs 10.6%) 5

Important Limitations

• The Cochrane systematic review (2019) concluded that racecadotril "has little benefit in improving acute diarrhoea in children" and does not support routine use outside of research contexts 7
• The IDSA guidelines note that racecadotril reduces stool volume but is not available in North America, effectively limiting its recommendation 1
• Most studies have moderate to high risk of bias, and the overall quality of evidence is limited 6, 7

Common Pitfalls to Avoid

• Do not use racecadotril as a substitute for oral rehydration therapy—it is only an adjunct and rehydration remains the cornerstone of treatment 2, 3, 4
• Do not confuse racecadotril with antimotility agents like loperamide—racecadotril is an antisecretory agent that does not affect intestinal motility and has a better safety profile than loperamide 1, 3, 5
• Never use loperamide in children <18 years as it has been associated with serious adverse events including deaths 1, 8
• Do not delay appropriate diagnostic workup or antimicrobial therapy when indicated (bloody diarrhea, fever, systemic toxicity) while using racecadotril 1, 2

Practical Algorithm for Use

1. Assess hydration status and initiate oral rehydration solution immediately 8, 2
2. Determine if diarrhea is watery (non-inflammatory) vs bloody/inflammatory 2
3. If watery diarrhea, child ≥3 months, and racecadotril available in your region: Consider adding racecadotril 1.5 mg/kg every 8 hours 2, 3, 4
4. If in North America or racecadotril unavailable: Focus exclusively on oral rehydration therapy, which successfully rehydrates >90% of children 8
5. Continue monitoring for signs of dehydration and need for escalation to IV therapy 8, 2