1. Clinical & Scientific Overview
Ilaprazole (TIP-MED-000296, Reference Code [5.14]-C26) is classified under
Gastrointestinal & Hepatobiliary Medicines (Ch 05) as a Modified Dual-Delayed-Release & Long-Half-Life Proton-Pump Inhibitors (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).
Co-indexed constituent under primary monograph [5.14] (Dexlansoprazole & Ilaprazole). Representative Indian Market Examples (Edition 2.7 Ch 05 [5.14], p. 66): Dexlansoprazole: Dexilant, Dexolan (Sun), DDR (Torrent). Ilaprazole: Ilapro (Ajanta), Adiza (Abbott) — Strengths & Dosage Forms: Dexlansoprazole Dual-Release Capsules: 30 mg, 60 mg. Ilaprazole Enteric-Coated Tablets: 5 mg, 10 mg
Dexlansoprazole Dual-Release Capsules: 30 mg, 60 mg. Ilaprazole Enteric-Coated Tablets: 5 mg, 10 mg
3. Mechanism of Action & Pharmacodynamics
Modified Dual-Delayed-Release & Long-Half-Life Proton-Pump Inhibitors (Schedule H) acting on target receptor/enzyme pathways in Gastrointestinal & Hepatobiliary Medicines (Ch 05): clinical efficacy is mediated via Modified Dual-Delayed-Release & Long-Half-Life Proton-Pump Inhibitors (Schedule H) for Erosive oesophagitis, refractory nocturnal GERD with night-time acid breakthrough, duodenal/gastric ulcer, and NSAID ulcer prophylaxis.
4. Therapeutic Indications & Evidence-Supported Uses
- Erosive oesophagitis, refractory nocturnal GERD with night-time acid breakthrough, duodenal/gastric ulcer, and NSAID ulcer prophylaxis
🇮🇳 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: Dexlansoprazole: 30 mg PO OD for symptomatic GERD; 60 mg PO OD for erosive oesophagitis (4–8 weeks). Ilaprazole: 5–10 mg PO OD before breakfast
Administration & Meal Timing: Dexlansoprazole contains two distinct enteric-coated granule populations (releasing at pH 5.5 and pH 6.75) and may be taken WITHOUT regard to meals; Ilaprazole should be taken 30 min before breakfast | Morning (Once Daily; Dexlansoprazole can also be taken before dinner for nocturnal GERD)
6. Pharmacokinetics, Metabolism & Renal/Hepatic Adjustment
Follows class pharmacokinetic profile detailed in parent monograph [5.14].
Renal: No adjustment needed. Hepatic: In moderate hepatic impairment (Child–Pugh B), cap Dexlansoprazole at max 30 mg OD and Ilaprazole at 5 mg OD; avoid in Child–Pugh C
Renal: No adjustment needed. Hepatic: In moderate hepatic impairment (Child–Pugh B), cap Dexlansoprazole at max 30 mg OD and Ilaprazole at 5 mg OD; avoid in Child–Pugh C
Renal: No adjustment needed. Hepatic: In moderate hepatic impairment (Child–Pugh B), cap Dexlansoprazole at max 30 mg OD and Ilaprazole at 5 mg OD; avoid in Child–Pugh C
7. Contraindications, Precautions & High-Risk Warnings
- Contraindicated with Rilpivirine; always exclude gastric malignancy if alarm symptoms (dysphagia, haematemesis, melaena, weight loss) are present
Key Clinical Precautions: Renal: No adjustment needed. Hepatic: In moderate hepatic impairment (Child–Pugh B), cap Dexlansoprazole at max 30 mg OD and Ilaprazole at 5 mg OD; avoid in Child–Pugh C
8. Adverse Effects Profile
- Diarrhoea, abdominal pain, nausea, flatulence, headache
- Long-term (>1 year) risks: Hypomagnesaemia, Vitamin B12/iron malabsorption, C. difficile colitis, osteoporotic fractures, acute interstitial nephritis (AIN)
9. Major Drug–Drug, Drug–Food & Drug–Herb Interactions
- Reduces gastric-acid-dependent absorption of Itraconazole, Ketoconazole, Iron salts, and Cefuroxime/Cefpodoxime; minimal CYP2C19 inhibition compared with Omeprazole
10. Clinical Monitoring, Patient Counselling & Storage
Clinical & Laboratory Monitoring: Monitor clinical parameters per parent monograph [5.14].
Pharmacist Patient Counselling Points:
- Patient Counselling Checklist: Swallow whole without chewing granules; useful when standard once-daily PPI fails to control midnight acid reflux; do not continue indefinitely without medical review
- Meal & Clock Timing Instruction: Dexlansoprazole contains two distinct enteric-coated granule populations (releasing at pH 5.5 and pH 6.75) and may be taken WITHOUT regard to meals; Ilaprazole should be taken 30 min before breakfast (Morning (Once Daily; Dexlansoprazole can also be taken before dinner for nocturnal GERD))
- Missed Dose Protocol: Take same day if remembered; skip if next day
- Geriatric Dispensing Pearl: Avoid >8 weeks of full-dose PPI in older adults unless on high-risk DAPT/anticoagulant/NSAID or Barrett's oesophagus (AGS Beers 2023)
Storage, Stability & Dispensing Safeguards: Store below 25°C–30°C in original moisture- and light-resistant packaging out of reach of children. Available forms: Dexlansoprazole Dual-Release Capsules: 30 mg, 60 mg. Ilaprazole Enteric-Coated Tablets: 5 mg, 10 mg
11. Visual Pharmacology & Mechanism Diagram (svg-v339-01-adme-12-step-journey)
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.
13. Related Reference Monographs, Educational Guides & Visual Concept
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