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MEDICINE MONOGRAPH CODE: [5.15]-C27 ID: TIP-MED-000297

Acotiamide

Active Ingredient / Scientific Identity: Acotiamide • Class: Peripheral D2 Antagonist + Acetylcholinesterase Inhibitor Gastroprokinetics (Schedule H)

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THE INDIAN PHARMACIST — Educational Reference Sheet
Profile: Acotiamide ([5.15]-C27 | ID: TIP-MED-000297) • Last Reviewed: 2026-11-10
Source URL: https://theindianpharmacist.com/medicine/5-15-c27-acotiamide/
Generic / Entity NameAcotiamide ([5.15]-C27)
Verified Indian Brands / RefGeneric Compendial Entry (No Commercial Brand Claimed)
Pharmacological ClassPeripheral D2 Antagonist + Acetylcholinesterase Inhibitor Gastroprokinetics (Schedule H)
Available Dosage FormsItopride Tablets: 50 mg IR, 150 mg SR (OD). Acotiamide Tablets: 100 mg
Regulatory ClassificationNon-Schedule / OTC or Schedule K Permitted Preparation (Medical Supervision Recommend
Key Warning & Review DateRenal & Hepatic: Reduce dose or extend interval in significant renal or hepatic impairment
Reviewed: 2026-11-10
Safety Matrix:⚖️ Legal Status: Non-Schedule / OTC or Schedule K Permitted Preparati✔️ Standard Clinical Dispensing Precautions

1. Clinical & Scientific Overview

Acotiamide (TIP-MED-000297, Reference Code [5.15]-C27) is classified under Gastrointestinal & Hepatobiliary Medicines (Ch 05) as a Peripheral D2 Antagonist + Acetylcholinesterase Inhibitor Gastroprokinetics (Schedule H). Within the Indian regulatory and compendial framework, it is governed under Non-Schedule / OTC or Schedule K Permitted Preparation (Medical Supervision Recommended for High-Dose/Therapeutic Regimens).

Verified Indian Market Examples / Compendial Status:
Co-indexed constituent under primary monograph [5.15] (Itopride Hydrochloride & Acotiamide). Representative Indian Market Examples (Edition 2.7 Ch 05 [5.15], p. 67): Itopride: Ganaton / Ganaton OD (Abbott), Itomis (Mankind), Itoflux. Acotiamide: Actapro (Lupin), Acogut (Sun) — Strengths & Dosage Forms: Itopride Tablets: 50 mg IR, 150 mg SR (OD). Acotiamide Tablets: 100 mg
Co-indexed constituent under primary monograph [5.15] (Itopride Hydrochloride & Acotiamide). Representative Indian Market Examples (Edition 2.7 Ch 05 [5.15], p. 67): Itopride: Ganaton / Ganaton OD (Abbott), Itomis (Mankind), Itoflux. Acotiamide: Actapro (Lupin), Acogut (Sun) — Strengths & Dosage Forms: Itopride Tablets: 50 mg IR, 150 mg SR (OD). Acotiamide Tablets: 100 mg
Dosage Forms & Available Strengths:
Itopride Tablets: 50 mg IR, 150 mg SR (OD). Acotiamide Tablets: 100 mg
Routes: Oral / Parenteral / Topical per formulation

3. Mechanism of Action & Pharmacodynamics

Peripheral D2 Antagonist + Acetylcholinesterase Inhibitor Gastroprokinetics (Schedule H) acting on target receptor/enzyme pathways in Gastrointestinal & Hepatobiliary Medicines (Ch 05): clinical efficacy is mediated via Peripheral D2 Antagonist + Acetylcholinesterase Inhibitor Gastroprokinetics (Schedule H) for Functional dyspepsia (postprandial distress syndrome: early satiety, post-meal fullness, upper abdominal bloating) and non-ulcer dyspepsia.

4. Therapeutic Indications & Evidence-Supported Uses

  • Functional dyspepsia (postprandial distress syndrome: early satiety, post-meal fullness, upper abdominal bloating) and non-ulcer dyspepsia

🇮🇳 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: Itopride: 50 mg IR PO TDS before meals (or 150 mg SR OD). Acotiamide: 100 mg PO TDS before meals

Administration & Meal Timing: Take 15–30 minutes BEFORE meals (swallow Itopride 150 mg SR whole) | Before Breakfast, Lunch & Dinner (TDS) or Morning (Itopride 150 mg OD)

6. Pharmacokinetics, Metabolism & Renal/Hepatic Adjustment

Absorption & Disposition:
Follows class pharmacokinetic profile detailed in parent monograph [5.15].
Metabolism & Biotransformation:
Renal & Hepatic: Reduce dose or extend interval in significant renal or hepatic impairment
Elimination & Renal Adjustment:
Renal & Hepatic: Reduce dose or extend interval in significant renal or hepatic impairment
Hepatic Impairment Considerations:
Renal & Hepatic: Reduce dose or extend interval in significant renal or hepatic impairment

7. Contraindications, Precautions & High-Risk Warnings

Contraindications & Red-Flag Precautions:
  • Contraindicated in GI haemorrhage, mechanical obstruction, or perforation. KEY SAFETY ADVANTAGE: Unlike Levosulpiride and Metoclopramide, Itopride is highly polar, does NOT cross the blood–brain barrier, does NOT cause drug-induced Parkinsonism/EPS, and does NOT prolong the QTc interval!

Key Clinical Precautions: Renal & Hepatic: Reduce dose or extend interval in significant renal or hepatic impairment

8. Adverse Effects Profile

Common & Mechanism-Related Adverse Effects:
  • Mild diarrhoea, abdominal pain, headache, rare mild prolactin rise
  • Rare hypersensitivity, leukopenia, or mild transaminase elevation
Serious / Dose-Limiting Adverse Effects:

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

    • Anticholinergic drugs (Dicyclomine, Hyoscine, Amitriptyline, Trihexyphenidyl) directly antagonise the prokinetic acetylcholine action of Itopride and Acotiamide! Metabolised by flavin monooxygenase (FMO3) rather than CYP450

    10. Clinical Monitoring, Patient Counselling & Storage

    Clinical & Laboratory Monitoring: Monitor clinical parameters per parent monograph [5.15].

    Pharmacist Patient Counselling Points:

    • Patient Counselling Checklist: Safer prokinetic choice than Levosulpiride or Metoclopramide because it does not cross into the brain to cause tremors/stiffness or affect heart rhythm (QTc); take 15–30 minutes before meals
    • Meal & Clock Timing Instruction: Take 15–30 minutes BEFORE meals (swallow Itopride 150 mg SR whole) (Before Breakfast, Lunch & Dinner (TDS) or Morning (Itopride 150 mg OD))
    • Missed Dose Protocol: Take before next meal if missed; never double dose
    • Geriatric Dispensing Pearl: Preferred gastroprokinetic in older adults and Parkinson's patients when prokinetic therapy is genuinely indicated

    Storage, Stability & Dispensing Safeguards: Store below 25°C–30°C in original moisture- and light-resistant packaging out of reach of children. Available forms: Itopride Tablets: 50 mg IR, 150 mg SR (OD). Acotiamide Tablets: 100 mg

    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/5-15-c27-acotiamide/, 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.