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MEDICINE MONOGRAPH CODE: [5.18]-C29 ID: TIP-MED-000299

Racecadotril

Active Ingredient / Scientific Identity: Racecadotril • Class: Peripheral Mu-Opioid Antidiarrhoeal & Antisecretory Enkephalinase Inhibitor (Schedule H)

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THE INDIAN PHARMACIST — Educational Reference Sheet
Profile: Racecadotril ([5.18]-C29 | ID: TIP-MED-000299) • Last Reviewed: 2026-11-10
Source URL: https://theindianpharmacist.com/medicine/5-18-c29-racecadotril/
Generic / Entity NameRacecadotril ([5.18]-C29)
Verified Indian Brands / RefGeneric Compendial Entry (No Commercial Brand Claimed)
Pharmacological ClassPeripheral Mu-Opioid Antidiarrhoeal & Antisecretory Enkephalinase Inhibitor (Schedule H)
Available Dosage FormsLoperamide Tablets/Capsules: 2 mg. Racecadotril: 100 mg Capsules (Adults); 10 mg & 30 mg Paediatric Granules/S
Regulatory ClassificationSchedule H Prescription Drug (To be sold by retail on the prescription of a Registere
Key Warning & Review DateRenal: No adjustment needed. Hepatic: Use caution in severe hepatic impairment (reduced first-pass clearance of Loperamide ->
Reviewed: 2026-11-10
Safety Matrix:⚖️ Legal Status: Schedule H Prescription Drug (To be sold by retail o✔️ Standard Clinical Dispensing Precautions

1. Clinical & Scientific Overview

Racecadotril (TIP-MED-000299, Reference Code [5.18]-C29) is classified under Gastrointestinal & Hepatobiliary Medicines (Ch 05) as a Peripheral Mu-Opioid Antidiarrhoeal & Antisecretory Enkephalinase Inhibitor (Schedule H). Within the Indian regulatory and compendial framework, it is governed under Schedule H Prescription Drug (To be sold by retail on the prescription of a Registered Medical Practitioner only — Drugs Rules 1945).

Verified Indian Market Examples / Compendial Status:
Co-indexed constituent under primary monograph [5.18] (Loperamide Hydrochloride & Racecadotril). Representative Indian Market Examples (Edition 2.7 Ch 05 [5.18], p. 68): Loperamide: Imodium (J&J), Eldoper (Micro Labs), Lopamide (Torrent). Racecadotril: Redotil (Dr. Reddy's), Zedott (Torrent), Enuff (Hetero) — Strengths & Dosage Forms: Loperamide Tablets/Capsules: 2 mg. Racecadotril: 100 mg Capsules (Adults); 10 mg & 30 mg Paediatric Granules/Sachets
Co-indexed constituent under primary monograph [5.18] (Loperamide Hydrochloride & Racecadotril). Representative Indian Market Examples (Edition 2.7 Ch 05 [5.18], p. 68): Loperamide: Imodium (J&J), Eldoper (Micro Labs), Lopamide (Torrent). Racecadotril: Redotil (Dr. Reddy's), Zedott (Torrent), Enuff (Hetero) — Strengths & Dosage Forms: Loperamide Tablets/Capsules: 2 mg. Racecadotril: 100 mg Capsules (Adults); 10 mg & 30 mg Paediatric Granules/Sachets
Dosage Forms & Available Strengths:
Loperamide Tablets/Capsules: 2 mg. Racecadotril: 100 mg Capsules (Adults); 10 mg & 30 mg Paediatric Granules/Sachets
Routes: Oral / Parenteral / Topical per formulation

3. Mechanism of Action & Pharmacodynamics

Peripheral Mu-Opioid Antidiarrhoeal & Antisecretory Enkephalinase Inhibitor (Schedule H) acting on target receptor/enzyme pathways in Gastrointestinal & Hepatobiliary Medicines (Ch 05): clinical efficacy is mediated via Peripheral Mu-Opioid Antidiarrhoeal & Antisecretory Enkephalinase Inhibitor (Schedule H) for Loperamide: Symptomatic control of acute non-infectious watery diarrhoea, traveller's diarrhoea, and high-output ileostomy. Racecadotril: Physiological antisecretory therapy for acute secretory watery diarrhoea in adults and children (>3 months) alongside WHO ORS + Zinc.

4. Therapeutic Indications & Evidence-Supported Uses

  • Loperamide: Symptomatic control of acute non-infectious watery diarrhoea, traveller's diarrhoea, and high-output ileostomy
  • Racecadotril: Physiological antisecretory therapy for acute secretory watery diarrhoea in adults and children (>3 months) alongside WHO ORS + Zinc

🇮🇳 Jurisdiction & Indication Note: Indications and schedules reflect Indian compendial and regulatory records (CDSCO / Indian Pharmacopoeia & NFI / NLEM 2022). Where international reference labels (US FDA DailyMed / NCBI StatPearls) are cited for pharmacokinetic or mechanistic parameters, international approvals do not automatically imply CDSCO approval in India.

5. Educational Dosage Context, Formulations & Administration

Educational Dosing & Regimen Summary: Loperamide (Adults): 4 mg (2 tabs) stat, then 2 mg after each loose stool (Max 16 mg/day for <=48 hours). Racecadotril (Adults): 100 mg PO TDS before meals (Max 7 days); Children (>3m): 1.5 mg/kg PO TDS

Administration & Meal Timing: Always administer alongside oral rehydration solution (WHO Low-Osmolarity ORS)! | Loperamide: After each loose stool. Racecadotril: Three times daily before main meals

6. Pharmacokinetics, Metabolism & Renal/Hepatic Adjustment

Absorption & Disposition:
Follows class pharmacokinetic profile detailed in parent monograph [5.18].
Metabolism & Biotransformation:
Renal: No adjustment needed. Hepatic: Use caution in severe hepatic impairment (reduced first-pass clearance of Loperamide -> CNS sedation)
Elimination & Renal Adjustment:
Renal: No adjustment needed. Hepatic: Use caution in severe hepatic impairment (reduced first-pass clearance of Loperamide -> CNS sedation)
Hepatic Impairment Considerations:
Renal: No adjustment needed. Hepatic: Use caution in severe hepatic impairment (reduced first-pass clearance of Loperamide -> CNS sedation)

7. Contraindications, Precautions & High-Risk Warnings

Contraindications & Red-Flag Precautions:
  • CONTRAINDICATIONS: Strictly contraindicated in acute dysentery (bloody/mucoid stools with high fever), suspected Shigella, Salmonella, or C. difficile colitis! Loperamide is CONTRAINDICATED in children <6–12 years (causes paralytic ileus & CNS depression!)

Key Clinical Precautions: Renal: No adjustment needed. Hepatic: Use caution in severe hepatic impairment (reduced first-pass clearance of Loperamide -> CNS sedation)

8. Adverse Effects Profile

Common & Mechanism-Related Adverse Effects:
  • Loperamide: Constipation, abdominal cramps, nausea, dizziness. Racecadotril: Headache (does NOT reduce gut motility or cause rebound constipation/ileus!)
  • Toxic megacolon and paralytic ileus (if Loperamide is used in invasive bacterial/amoebic dysentery or young children); supratherapeutic Loperamide abuse causes fatal QTc prolongation
Serious / Dose-Limiting Adverse Effects:

    9. Major Drug–Drug, Drug–Food & Drug–Herb Interactions

    • P-gp inhibitors (Quinidine, Ritonavir, Itraconazole, Verapamil) allow Loperamide to cross the blood–brain barrier causing central opioid respiratory depression

    10. Clinical Monitoring, Patient Counselling & Storage

    Clinical & Laboratory Monitoring: Monitor clinical parameters per parent monograph [5.18].

    Pharmacist Patient Counselling Points:

    • Patient Counselling Checklist: ORS is the primary life-saving treatment for diarrhoea; NEVER give Loperamide (Imodium/Eldoper) to young children or anyone with bloody stools or high fever (Racecadotril sachets + ORS + Zinc 20 mg OD are used in children)
    • Meal & Clock Timing Instruction: Always administer alongside oral rehydration solution (WHO Low-Osmolarity ORS)! (Loperamide: After each loose stool. Racecadotril: Three times daily before main meals)
    • Missed Dose Protocol: Stop once formed stools return
    • Geriatric Dispensing Pearl: Avoid high doses of Loperamide in older adults due to faecal impaction and paralytic ileus risk

    Storage, Stability & Dispensing Safeguards: Store below 25°C–30°C in original moisture- and light-resistant packaging out of reach of children. Available forms: Loperamide Tablets/Capsules: 2 mg. Racecadotril: 100 mg Capsules (Adults); 10 mg & 30 mg Paediatric Granules/Sachets

    11. Visual Pharmacology & Mechanism Diagram (svg-v339-01-adme-12-step-journey)

    THE 12-STEP ORAL DRUG JOURNEY THROUGH THE HUMAN BODY (LADME) Note: IV bolus enters Step 6 directly (F = 100%); Sublingual & Transdermal routes bypass Step 4–5 Portal First-Pass Metabolism 1. Oral Administration • Tablet / Capsule swallowed • Gastric emptying to duodenum pH 1.5–3.5 (Stomach) 2. Disintegration & Dissolution • Tablet breaks into granules • API dissolves in GI fluid Noyes-Whitney Dissolution Rate 3. GI Epithelial Absorption • Crosses intestinal villi • Passive / Active / P-gp efflux Small Intestine (Large Surface Area) 4. Portal Circulation • Mesenteric veins → Portal vein • Delivers blood to liver sinusoids Pre-systemic Venous Conduit 5. First-Pass Metabolism • Gut & hepatic CYP450 extraction • High: GTN, Propranolol, Morphine Determines Bioavailability (F = f_a × (1-E_H)) 6. Systemic Circulation • Hepatic vein → IVC → Heart • Unbound vs Albumin-bound drug Only FREE drug is active 7–8. Tissue Distribution (Vd) • Capillary permeation to organs • Blood-Brain & Placental barriers Vd = Dose / C_0 (L or L/kg) 9. Target Site of Action • Receptors (GPCR, Ion channel) • Enzymes & Carrier Transporters Pharmacodynamic Effect (E_max, EC50) 10. Hepatic Biotransformation • Phase I (CYP450 Oxidation/Hydrolysis) • Phase II (Glucuronidation/Sulfation) Converts lipophilic drug → hydrophilic metabolite 11. Renal & Biliary Elimination • Nephron: Filtration + Secretion − Reabsorption • Biliary excretion & Enterohepatic recycling Total Clearance CL_tot = CL_renal + CL_hepatic 12. Excretion from the Body • Urine (Primary polar metabolite route) • Bile/Faeces, Expired Air, Sweat, Milk Elimination Half-Life t1/2 = (0.693 × Vd) / CL
    svg-v339-01-adme-12-step-journey — 8.1 Complete 12-Step Journey of an Orally Administered Drug (ADME): Figure 8.1: The 12-step physiological journey of a typical orally administered solid dosage form through Liberation, Absorption, Distribution, Metabolism, and Excretion (LADME). Note: Parenteral (IV), sublingual, and inhalational routes bypass gastrointestinal absorption and/or hepatic first-pass metabolism.

    12. Authoritative References, Regulatory Sources & Editorial Disclaimer

    Primary Compendial & Guideline Reference: Indian Pharmacopoeia (IP 2022) • NFI • CDSCO

    Official Verification Portals: Indian Pharmacopoeia Commission (IPC) & National Formulary of India (NFI) • Central Drugs Standard Control Organization (CDSCO) • Ministry of Health & Family Welfare — NLEM 2022 • NCBI Bookshelf / StatPearls Pharmacology Reference • DailyMed (US FDA Official Prescribing Reference)

    Last Medically & Pharmaceutically Reviewed: 2026-11-10 • Verification Status: VERIFIED_EDUCATIONAL_CONTENT

    Educational & Clinical Disclaimer: This reference profile is published solely for pharmacy education, academic study, and professional clinical reference. It does not substitute for patient-specific clinical judgement, qualified specialist oncology/medical supervision, or official CDSCO/IP prescribing information. Never self-medicate with prescription, Schedule H/H1/X, NDPS, or oncology medicines.

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    Educational Reference Notice: This printout from THE INDIAN PHARMACIST (https://theindianpharmacist.com/medicine/5-18-c29-racecadotril/, Last Reviewed: 2026-11-10) is an educational reference sheet for students and healthcare learners. It is NOT an official prescribing guideline or patient-specific treatment order.