What is the recommended dose and contraindications of Redotil (racecadotril) for children over 3 months with acute watery diarrhoea?

Racecadotril (Redotil) Recommendations for Children with Acute Watery Diarrhea

Racecadotril is not routinely recommended for children with acute diarrhea, as current evidence shows it has little clinical benefit beyond oral rehydration therapy alone, and it is not available in North America. 1

Evidence Assessment

Guideline Position

The Infectious Diseases Society of America (IDSA) 2017 guidelines explicitly state that racecadotril reduces stool volume but is not available in North America and does not provide a recommendation for its routine use. 1 The guidelines prioritize oral rehydration solution (ORS) as the cornerstone of treatment for acute diarrhea in children, with adjunctive therapies having limited roles. 1

Research Evidence Quality

A 2019 Cochrane systematic review (the highest quality evidence available) analyzed 7 RCTs with 1,140 children aged 3 months to 5 years and concluded that racecadotril "seems to be a safe drug but has little benefit in improving acute diarrhea in children under five years of age." 2 The review found:

• Low-certainty evidence that racecadotril may reduce rehydration failure (RR 0.41,95% CI 0.13 to 1.23) 2
• Insufficient data on duration of diarrhea and number of stools to reach conclusions 2
• No increase in adverse events (RR 0.90,95% CI 0.66 to 1.22) 2
• The Cochrane review explicitly 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." 2

Dosing Information (If Used)

If racecadotril is prescribed in regions where it is available:

• Dose: 1.5 mg/kg orally three times daily (every 8 hours) 3, 4, 5
• Age: Children 3 months to 5 years 3, 4, 2, 5
• Duration: Continue until diarrhea resolves, typically 3-5 days 3, 5
• Administration: Always as adjunct to oral rehydration solution, never as monotherapy 4, 5

Contraindications and Precautions

Absolute contraindications:

• Bloody diarrhea or suspected inflammatory diarrhea 6
• Fever with diarrhea (risk of toxic megacolon) 1, 6
• Severe dehydration requiring IV fluids (start ORS/IV first, consider racecadotril only after stabilization) 6
• Children under 3 months of age (no safety data) 3, 4, 2

Relative contraindications:

• Suspected STEC infection (antimotility effects theoretically could worsen outcomes, though racecadotril is antisecretory not antimotility) 1
• Immunocompromised children (limited safety data) 6

Recommended Management Algorithm

For all children with acute watery diarrhea:

1. Assess dehydration severity (mild 3-5%, moderate 6-9%, severe ≥10%) using skin turgor, mucous membranes, mental status, and capillary refill 7, 8

2. Initiate oral rehydration solution immediately:

   • Mild dehydration: 50 mL/kg ORS over 2-4 hours 8
   • Moderate dehydration: 100 mL/kg ORS over 2-4 hours 8
   • Severe dehydration: IV isotonic fluids until stabilized, then transition to ORS 8

3. Replace ongoing losses: 10 mL/kg ORS per watery stool, 2 mL/kg per vomiting episode 7, 8

4. Resume age-appropriate diet immediately during or after rehydration 7, 8

5. Consider adjunctive therapies only if appropriate:

   • Ondansetron for children >4 years with significant vomiting to facilitate ORS tolerance 1, 7
   • Zinc supplementation for children 6 months-5 years in zinc-deficient regions or with malnutrition 1, 7
   • Probiotics may reduce symptom severity and duration 1, 7

6. Do NOT use racecadotril routinely based on current evidence 2

Special Populations

Immunotherapy-Induced Diarrhea (Cancer Patients)

Racecadotril has a specific role in Grade 1 immunotherapy-induced diarrhea in cancer patients as part of symptomatic treatment alongside ORS. 6 However, this is a distinct clinical scenario from acute infectious gastroenteritis in otherwise healthy children. 6

Common Pitfalls to Avoid

• Do not delay ORS administration while considering adjunctive therapies like racecadotril—rehydration is the priority 7, 8
• Do not use racecadotril in place of ORS—it must always be adjunctive 4, 5
• Do not confuse racecadotril with loperamide—loperamide is absolutely contraindicated in children <18 years, while racecadotril has a different mechanism (antisecretory vs antimotility) 1, 7
• Do not use racecadotril for bloody diarrhea or fever—these suggest inflammatory or bacterial causes requiring different management 1, 6
• Recognize geographic availability—racecadotril is not available in North America, limiting its practical utility in many settings 1

Clinical Bottom Line

Prioritize oral rehydration solution as the definitive treatment for acute watery diarrhea in children. 1, 7, 8 Racecadotril may reduce stool output by approximately 46-50% in research settings, but the 2019 Cochrane review demonstrates this does not translate to meaningful clinical benefits in real-world practice. 2, 5 The drug appears safe with no serious adverse events reported, but given the lack of demonstrated benefit on patient-centered outcomes (rehydration failure, hospitalization, mortality), routine use cannot be justified. 2, 9