What is the recommended dose of Racecadotril (acetorphan) for adults and children?

Racecadotril Dosing Recommendations

Adult Dosing

For adults with acute diarrhea, racecadotril should be administered at 100 mg three times daily (every 8 hours) as an adjunct to oral rehydration therapy. 1

• This dosing regimen has been consistently validated across multiple randomized controlled trials in adults with acute infectious diarrhea 2, 3
• The medication is taken orally and does not require dose adjustment based on body weight in adults 3
• Treatment should continue until diarrhea resolves, typically within 24-72 hours 2
• Newer formulations may allow for twice-daily dosing in adults, though the traditional three-times-daily regimen remains standard 4

Pediatric Dosing

For children with acute watery diarrhea, racecadotril should be dosed at 1.5 mg/kg body weight orally every 8 hours (three times daily). 5

• This weight-based dosing has been proven effective and safe in children aged 3 months to 35 months 5
• The medication significantly reduces stool output by approximately 46% compared to placebo when added to oral rehydration therapy 5
• Pediatric syrup formulations are available to simplify administration 4
• Racecadotril is not recommended for children under 3 months of age based on available safety data 5

Clinical Context and Mechanism

• Racecadotril works as an enkephalinase inhibitor, reducing pathologic intestinal secretion without affecting gastrointestinal motility or transit time 6, 3
• Unlike loperamide, it does not cause rebound constipation, making it particularly advantageous for symptom resolution 2, 3
• The active metabolite (thiorphan) does not cross the blood-brain barrier, contributing to its favorable safety profile 6

Special Populations

In immunotherapy-induced diarrhea (Grade 1), racecadotril or loperamide can be used as first-line symptomatic treatment alongside oral rehydration. 1

• This recommendation comes from ESMO Clinical Practice Guidelines for cancer patients 1
• For higher grades of immunotherapy-induced diarrhea, corticosteroids become necessary and opioids should be avoided 1

Comparative Efficacy

• Racecadotril demonstrates similar efficacy to loperamide but with superior tolerability, particularly regarding post-diarrheal constipation 2, 3
• In hospitalized patients requiring antibiotics and rehydration, octreotide may be more effective than racecadotril for severe cases 2
• The medication reduces duration of diarrhea to approximately 28 hours compared to 52-72 hours with placebo 5