Not scheduled (OTC in some formulations; prescription-only for paediatric sachets in practice)

Oral

• Capsule: 100 mg

• Sachet (granules for oral suspension): 10 mg, 30 mg

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

ACUTE DIARRHOEA — Adults

Parameter Recommendation

Starting dose 100 mg orally (first dose), regardless of meal timing

Titration Not required

Usual maintenance dose 100 mg three times daily

Maximum dose 400 mg on Day 1 (100 mg initial + 100 mg TID); 300 mg/day thereafter

Clinical Notes:

• Continue until two normal stools are passed; do not exceed 7 days of treatment

• Must be used as adjunct to oral rehydration therapy (ORT) — not as monotherapy

• Onset of action: typically within 24–48 hours

• Does not reduce intestinal motility; does not cause rebound constipation like loperamide

Secondary Indications — Adults (Off-label)

Indication Dose Duration Notes Evidence

Chronic secretory diarrhoea (e.g., diabetic autonomic neuropathy, post-vagotomy) 100 mg TID As per specialist decision Specialist only — OFF-LABEL Small-scale RCTs; Indian specialist gastroenterology practice

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

ACUTE DIARRHOEA — Children (≥3 months of age)

Weight Dose per administration Frequency Notes

<9 kg 10 mg TID (before meals) Use 10 mg sachet

9–13 kg 20 mg TID (before meals) Use two 10 mg sachets

13–27 kg 30 mg TID (before meals) Use 30 mg sachet

27 kg 60 mg TID (before meals) Use two 30 mg sachets

Clinical Notes:

• Starting dose: Weight-based as above; first dose at onset of treatment

• Titration: Not applicable

• Usual maintenance dose: Weight-based TID dosing as above

• Maximum duration: 5–7 days or until stools normalise (whichever is earlier)

• Minimum age: 3 months; use below 3 months only under paediatric gastroenterologist supervision

• Always co-administer with ORT — Racecadotril is never sole therapy

• Sachets may be mixed with water, food, or milk; ensure complete dose administration

Safety and Monitoring:

• Assess hydration status at each visit

• Monitor for clinical improvement within 48 hours

• If no improvement in 48–72 hours, reassess diagnosis

• Observe for rebound constipation (rare)

Secondary Indications — Paediatrics (Off-label)

Indication Dose Duration Notes Evidence

Chronic diarrhoea (metabolic/neurological causes) Same weight-based dosing as acute diarrhoea As per specialist decision Specialist only — OFF-LABEL Limited; observational use in neurodevelopmental centres

Mild to moderate impairment No dose adjustment required

• Known hypersensitivity to Racecadotril or any excipient

• Age <3 months (except under paediatric specialist supervision)

• Bloody or mucoid diarrhoea (suggests invasive bacterial/amoebic aetiology)

• Diarrhoea with high fever suggesting invasive infection

• Antibiotic-associated diarrhoea / pseudomembranous colitis

• Hereditary fructose intolerance (sachet formulations contain sucrose)

• Chronic diarrhoea of non-secretory origin (e.g., malabsorption syndromes)

• Severe renal impairment — limited pharmacokinetic data

• Hepatic impairment — use cautiously, avoid in severe disease

• Prolonged diarrhoea (>7 days) without response — re-evaluate underlying cause

• Dehydration or electrolyte imbalance — correct with ORT before/during treatment

• Patients with history of angioedema (theoretical ACE inhibitor-like effect)

• Immunocompromised patients — rule out opportunistic infections first

Parameter Details

Safety classification Not formally classified; limited human data

Overall recommendation Avoid unless benefit clearly outweighs risk; avoid in first trimester

Preferred alternatives Oral rehydration therapy; loperamide (short-term, if required)

When may be used Only after ORT failure, specialist input, second/third trimester

Monitoring Maternal hydration status; foetal wellbeing if prolonged use

Parameter Details

Compatibility Likely compatible; minimal systemic absorption of active metabolite

Drug levels in milk Expected to be negligible

Preferred alternatives ORT alone; supportive care

Infant monitoring Observe for GI disturbance, loose stools, feeding difficulties

Parameter Recommendation

Starting dose 100 mg twice daily (BID) initially

Titration Cautious increase to TID if tolerated and required

Special risks Dehydration, hypovolaemia, falls risk, electrolyte disturbances

Monitoring Ensure adequate oral fluid intake; assess renal function at baseline

Interacting Drug Mechanism/Effect Management

ACE inhibitors (e.g., enalapril, ramipril) Theoretical increased risk of angioedema (both affect enkephalin/bradykinin pathways) Monitor closely; avoid if prior history of angioedema

Interacting Drug Mechanism/Effect Management

Loperamide No added benefit; potential risk of constipation/ileus Avoid concurrent use

Other antidiarrhoeals (diphenoxylate) Unclear additive benefit; risk of over-suppression Avoid dual therapy

Note: Racecadotril has minimal systemic absorption and no significant CYP450 interactions.

• Headache

• Nausea

• Flatulence

• Abdominal distension

• Constipation (uncommon)

Adverse Effect Action Required

Angioedema (face, lips, tongue, larynx) Discontinue immediately; emergency management

Severe skin reactions (urticaria with systemic symptoms, erythema multiforme) Discontinue immediately; do not rechallenge

Severe hypersensitivity/anaphylaxis Discontinue; emergency treatment

Phase Parameters

Baseline Rule out invasive diarrhoea (blood/mucus/high fever); assess hydration status; electrolytes if moderate-severe dehydration

During treatment Stool frequency and consistency; hydration status; clinical response within 48 hours

Long-term Not applicable — not intended for chronic use without specialist oversight

• Redotril® (Abbott)

• Tiorfan®

• Zedott®

• Cadotril®

• Racedot®

• Diarfix®

Note: Sachets (10 mg, 30 mg) available for paediatric use; capsules (100 mg) for adults.

• NLEM status: Not included in current NLEM

• DPCO controlled: No

1. Key differentiator: Racecadotril does not inhibit intestinal motility (unlike loperamide), making it preferred in paediatric viral gastroenteritis where motility suppression may trap pathogens.

1. Timing matters: Initiate within 24–48 hours of diarrhoea onset for maximum efficacy.

1. Never monotherapy: Racecadotril is always adjunctive to ORT — emphasise continued fluid/electrolyte replacement to patients/caregivers.

1. When NOT to use: Avoid in suspected invasive bacterial diarrhoea (fever, blood, mucus) — may delay appropriate antibiotic therapy.

1. Paediatric administration: Sachets can be mixed with water, milk, or soft food; ensure full dose is consumed immediately after preparation.

1. Duration limit: Do not exceed 7 days; if diarrhoea persists beyond 48–72 hours, reassess diagnosis.

Racecadotril; diarrhoea; antidiarrhoeal; enkephalinase inhibitor; paediatric diarrhoea; ORT adjunct; viral gastroenteritis; secretory diarrhoea; gastroenterology

RxIndia v1.1 — 09 Jan 2025

• CDSCO approved product information

• Indian Pharmacopoeia

• IAP Guidelines for Management of Acute Diarrhoea in Children

• WHO Guidelines on Diarrhoeal Disease Management

• API Textbook of Medicine

• AIIMS Standard Treatment Guidelines

• Indian paediatric gastroenterology hospital protocols