How should Hidrasec (racecadotril) be administered to adults and children, including appropriate dosing and co‑administration with oral rehydration solution?

Administration of Hidrasec (Racecadotril)

Hidrasec (racecadotril) should be administered as an adjunct to oral rehydration solution (ORS), not as monotherapy, at a dose of 1.5 mg/kg orally three times daily (every 8 hours) in children aged 3 months and older, always ensuring adequate rehydration is achieved first. 1, 2, 3

Core Principle: Always Co-Administer with ORS

• Racecadotril must never be used alone—it is an adjunctive therapy that works alongside oral rehydration solution, which remains the cornerstone of acute diarrhea management. 4, 1, 5
• The drug reduces pathologic intestinal water and electrolyte secretion without affecting gut motility, making it fundamentally different from antimotility agents like loperamide. 1, 5

Dosing Regimen

Children (3 months to 5 years)

• Standard dose: 1.5 mg/kg body weight administered orally every 8 hours (three times daily). 2, 3
• Treatment duration typically continues until diarrhea resolves, usually 3–5 days based on clinical trials. 2, 3

Adults

• Racecadotril has been studied in adults with acute diarrhea and demonstrates efficacy, though specific adult dosing is typically higher than pediatric weight-based dosing. 5

Administration Sequence

1. First priority: Begin ORS immediately at 100 mL/kg over 2–4 hours for moderate dehydration (6–9% fluid deficit). 4, 6
2. Add racecadotril once rehydration therapy is initiated, not before assessing and addressing hydration status. 4, 1
3. Replace ongoing losses: After initial rehydration, give additional ORS after each diarrheal stool:
   • Children <10 kg: 60–120 mL per stool 6
   • Children >10 kg: 120–240 mL per stool 6
   • Continue racecadotril throughout this maintenance phase. 2, 3

Expected Clinical Effects

• Stool output reduction: Racecadotril reduces 48-hour stool output by approximately 46–50% compared to ORS alone. 2, 3
• Duration of diarrhea: Median duration decreases from 52–72 hours (placebo) to approximately 28 hours with racecadotril. 3
• ORS requirement: Total intake of oral rehydration solution is significantly lower when racecadotril is added. 3

Safety Profile and Contraindications

• Racecadotril has a favorable safety profile with no serious adverse events reported in pediatric trials; most adverse effects are mild and transient. 1, 2, 3
• The drug does not cross the blood-brain barrier, avoiding central nervous system effects. 5
• Unlike loperamide, racecadotril does not cause rebound constipation and can be used in children. 5
• However, it should not replace appropriate evaluation for alarm signs: bloody stools, fever ≥38.5°C, severe abdominal pain, or signs of dehydration requiring IV therapy. 4

Critical Pitfalls to Avoid

• Never use racecadotril as monotherapy—ORS remains mandatory and is the only WHO-recommended treatment for acute diarrhea. 4, 2
• Do not delay rehydration to administer racecadotril; assess hydration status first and initiate ORS immediately. 4, 6
• Avoid empiric antibiotics in simple watery diarrhea, as they are contraindicated and may worsen outcomes (especially in STEC infections). 4, 7
• Continue breastfeeding throughout the illness in infants, and resume age-appropriate diet during or immediately after rehydration. 4, 6, 7

Evidence Quality Considerations

• While multiple RCTs demonstrate racecadotril's efficacy in reducing stool output and duration, a 2019 Cochrane review concluded that the clinical benefit is modest and does not support routine use outside controlled trials. 8
• The drug appears most beneficial in reducing healthcare resource utilization (shorter hospital stays, less ORS consumption) rather than preventing mortality or severe complications. 1, 8
• Current guidelines prioritize ORS as first-line therapy, with racecadotril considered an optional adjunct in settings where it is available and affordable. 4, 5

When to Escalate Care

• If the child develops signs of severe dehydration (altered mental status, shock, inability to tolerate oral intake), switch immediately to isotonic IV fluids (lactated Ringer's or normal saline) and discontinue oral medications until stabilized. 4, 6
• Reassess hydration status after 2–4 hours of treatment; if dehydration persists or worsens despite racecadotril and ORS, escalate to inpatient care. 4, 6