What is the recommended dosage of racecadotril (acetorphan) for a 1-year-old child?

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Racecadotril Dosage for a 1-Year-Old Child

The recommended dosage of racecadotril for a 1-year-old child is 1.5 mg/kg administered orally every 8 hours (three times daily) for up to 3 days, given as adjunctive therapy to oral rehydration solution. 1, 2

Weight-Based Dosing Calculation

  • For a typical 1-year-old weighing approximately 9-11 kg, the dose would be 13.5-16.5 mg per dose (1.5 mg/kg × body weight), administered three times daily at 8-hour intervals 1, 2
  • The medication should be continued for a maximum of 3 days alongside standard oral rehydration therapy 3, 4

Administration Guidelines

  • Always combine racecadotril with oral rehydration solution—it is not a replacement for rehydration therapy but rather an adjunctive antisecretory agent 1, 2
  • Administer the dose orally every 8 hours (three times per day) 1, 4
  • Treatment duration should not exceed 3 days in most clinical scenarios 3

Evidence Quality and Clinical Context

The dosing recommendation of 1.5 mg/kg three times daily is based on multiple randomized controlled trials in children aged 3 months to 4 years, including specific studies in hospitalized boys 3-35 months of age 1, 2. However, the clinical benefit of racecadotril remains controversial:

  • Early studies from 2000-2002 showed significant reductions in stool output (46-50% reduction) and duration of diarrhea in hospitalized children 1, 2, 4
  • More recent evidence from 2016 and a 2019 Cochrane review found no significant benefit in reducing diarrheal duration, stool volume, or fluid replacement requirements in both rotavirus and non-rotavirus diarrhea 5, 3
  • The 2019 Cochrane review concluded that racecadotril has little benefit and does not support routine use outside of placebo-controlled trials 5

Safety Profile

  • Racecadotril appears to be well-tolerated with mostly mild and transient adverse effects 1, 2
  • The overall rate of adverse events is similar to placebo (RR 0.90,95% CI 0.66 to 1.22) 5
  • Most adverse events reported were mild or moderate in severity 5

Critical Availability Caveat

Racecadotril is not available in North America 6. This medication is primarily used in Europe, Latin America, and parts of Asia. If you are practicing in the United States or Canada, this medication cannot be prescribed.

Clinical Recommendation

Given the conflicting evidence and lack of availability in North America, prioritize standard oral rehydration therapy as the primary treatment for acute diarrhea in a 1-year-old child 5. If racecadotril is available in your region and you choose to use it despite limited evidence of benefit, the dose is 1.5 mg/kg every 8 hours for up to 3 days as adjunctive therapy only 1, 2.

References

Research

Racecadotril in the treatment of acute watery diarrhea in children.

The New England journal of medicine, 2000

Research

[Effect of racecadotril in the management of acute diarrhea in infants and children].

Archives de pediatrie : organe officiel de la Societe francaise de pediatrie, 2002

Research

Racecadotril for acute diarrhoea in children.

The Cochrane database of systematic reviews, 2019

Guideline

Racecadotril in Pediatric Diarrhea Management

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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