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MEDICINE MONOGRAPH CODE: [4.18]-C17 ID: TIP-MED-000287

Alogliptin

Active Ingredient / Scientific Identity: Alogliptin • Class: Dipeptidyl Peptidase-4 (DPP-4) Inhibitors (Schedule H)

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THE INDIAN PHARMACIST — Educational Reference Sheet
Profile: Alogliptin ([4.18]-C17 | ID: TIP-MED-000287) • Last Reviewed: 2026-11-10
Source URL: https://theindianpharmacist.com/medicine/4-18-c17-alogliptin/
Generic / Entity NameAlogliptin ([4.18]-C17)
Verified Indian Brands / RefGeneric Compendial Entry (No Commercial Brand Claimed)
Pharmacological ClassDipeptidyl Peptidase-4 (DPP-4) Inhibitors (Schedule H)
Available Dosage FormsSaxagliptin Tablets: 2.5 mg, 5 mg. Alogliptin Tablets: 6.25 mg, 12.5 mg, 25 mg
Regulatory ClassificationSchedule H & Schedule G Prescription Drug ('Caution: It is dangerous to take this pre
Key Warning & Review DateRenal: Saxagliptin: 2.5 mg OD if eGFR <45 mL/min. Alogliptin: 12.5 mg OD (eGFR 30–59) or 6.25 mg OD (eGFR <30). Hepatic: Avoi
Reviewed: 2026-11-10
Safety Matrix:⚖️ Legal Status: Schedule H & Schedule G Prescription Drug ('Caution:✔️ Standard Clinical Dispensing Precautions

1. Clinical & Scientific Overview

Alogliptin (TIP-MED-000287, Reference Code [4.18]-C17) is classified under Antidiabetic Medicines, Insulins & GLP-1 Agonists (Ch 04) as a Dipeptidyl Peptidase-4 (DPP-4) Inhibitors (Schedule H). Within the Indian regulatory and compendial framework, it is governed under Schedule H & Schedule G Prescription Drug ('Caution: It is dangerous to take this preparation except under medical supervision' — Drugs Rules 1945).

Verified Indian Market Examples / Compendial Status:
Co-indexed constituent under primary monograph [4.18] (Saxagliptin & Alogliptin). Representative Indian Market Examples (Edition 2.7 Ch 04 [4.18], p. 53): Saxagliptin: Onglyza (AstraZeneca), Riax (Dr. Reddy's). Alogliptin: Nesina, Aloglipt — Strengths & Dosage Forms: Saxagliptin Tablets: 2.5 mg, 5 mg. Alogliptin Tablets: 6.25 mg, 12.5 mg, 25 mg
Co-indexed constituent under primary monograph [4.18] (Saxagliptin & Alogliptin). Representative Indian Market Examples (Edition 2.7 Ch 04 [4.18], p. 53): Saxagliptin: Onglyza (AstraZeneca), Riax (Dr. Reddy's). Alogliptin: Nesina, Aloglipt — Strengths & Dosage Forms: Saxagliptin Tablets: 2.5 mg, 5 mg. Alogliptin Tablets: 6.25 mg, 12.5 mg, 25 mg
Dosage Forms & Available Strengths:
Saxagliptin Tablets: 2.5 mg, 5 mg. Alogliptin Tablets: 6.25 mg, 12.5 mg, 25 mg
Routes: Oral / Parenteral / Topical per formulation

3. Mechanism of Action & Pharmacodynamics

Dipeptidyl Peptidase-4 (DPP-4) Inhibitors (Schedule H) acting on target receptor/enzyme pathways in Antidiabetic Medicines, Insulins & GLP-1 Agonists (Ch 04): clinical efficacy is mediated via Dipeptidyl Peptidase-4 (DPP-4) Inhibitors (Schedule H) for Type 2 Diabetes Mellitus as adjunct to diet, exercise, and Metformin/SGLT2i (in patients without heart failure).

4. Therapeutic Indications & Evidence-Supported Uses

  • Type 2 Diabetes Mellitus as adjunct to diet, exercise, and Metformin/SGLT2i (in patients without heart failure)

🇮🇳 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: Saxagliptin: 5 mg PO OD (Reduce to 2.5 mg OD if eGFR <45 mL/min or with strong CYP3A4 inhibitors). Alogliptin: 25 mg OD (12.5 mg OD if eGFR 30–59; 6.25 mg OD if eGFR <30)

Administration & Meal Timing: May be taken with or without food; swallow Saxagliptin tablets whole (do not split or cut film-coated tablets!) | Morning (Once Daily)

6. Pharmacokinetics, Metabolism & Renal/Hepatic Adjustment

Absorption & Disposition:
Follows class pharmacokinetic profile detailed in parent monograph [4.18].
Metabolism & Biotransformation:
Renal: Saxagliptin: 2.5 mg OD if eGFR <45 mL/min. Alogliptin: 12.5 mg OD (eGFR 30–59) or 6.25 mg OD (eGFR <30). Hepatic: Avoid in severe hepatic impairment
Elimination & Renal Adjustment:
Renal: Saxagliptin: 2.5 mg OD if eGFR <45 mL/min. Alogliptin: 12.5 mg OD (eGFR 30–59) or 6.25 mg OD (eGFR <30). Hepatic: Avoid in severe hepatic impairment
Hepatic Impairment Considerations:
Renal: Saxagliptin: 2.5 mg OD if eGFR <45 mL/min. Alogliptin: 12.5 mg OD (eGFR 30–59) or 6.25 mg OD (eGFR <30). Hepatic: Avoid in severe hepatic impairment

7. Contraindications, Precautions & High-Risk Warnings

Contraindications & Red-Flag Precautions:
  • HEART FAILURE WARNING (SAVOR-TIMI 53): Saxagliptin increased hospitalisation for heart failure by 27% — AVOID Saxagliptin (and Alogliptin) in patients with established Heart Failure or moderate-to-severe CKD (prefer SGLT2i or Sitagliptin/Linagliptin!). Contraindicated in Type 1 DM, DKA, and prior pancreatitis

Key Clinical Precautions: Renal: Saxagliptin: 2.5 mg OD if eGFR <45 mL/min. Alogliptin: 12.5 mg OD (eGFR 30–59) or 6.25 mg OD (eGFR <30). Hepatic: Avoid in severe hepatic impairment

8. Adverse Effects Profile

Common & Mechanism-Related Adverse Effects:
  • Upper respiratory tract infection, urinary tract infection, headache, peripheral oedema
  • Hospitalisation for Heart Failure (dyspnoea, orthopnoea, rapid weight gain/ankle swelling), acute pancreatitis, severe arthralgia, bullous pemphigoid
Serious / Dose-Limiting Adverse Effects:

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

    • Strong CYP3A4/5 inhibitors (Clarithromycin, Itraconazole, Ketoconazole) double Saxagliptin exposure -> reduce Saxagliptin to 2
    • 5 mg OD! Additive hypoglycaemia with Sulfonylureas/Insulin

    10. Clinical Monitoring, Patient Counselling & Storage

    Clinical & Laboratory Monitoring: Monitor clinical parameters per parent monograph [4.18].

    Pharmacist Patient Counselling Points:

    • Patient Counselling Checklist: Swallow tablet whole without cutting; report any shortness of breath when lying flat, sudden ankle swelling, or severe stomach pain immediately
    • Meal & Clock Timing Instruction: May be taken with or without food; swallow Saxagliptin tablets whole (do not split or cut film-coated tablets!) (Morning (Once Daily))
    • Missed Dose Protocol: Take same day if remembered; skip if next day
    • Geriatric Dispensing Pearl: Avoid Saxagliptin in older adults with heart failure or reduced eGFR; prefer Linagliptin or Sitagliptin

    Storage, Stability & Dispensing Safeguards: Store below 25°C–30°C in original moisture- and light-resistant packaging out of reach of children. Available forms: Saxagliptin Tablets: 2.5 mg, 5 mg. Alogliptin Tablets: 6.25 mg, 12.5 mg, 25 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/4-18-c17-alogliptin/, 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.