1. Clinical & Scientific Overview
Vildagliptin (TIP-MED-000047, Reference Code [4.3]) is classified under
Antidiabetic Medicines, Insulins & GLP-1 Agonists (Ch 04) as a Dipeptidyl Peptidase-4 (DPP-4) Inhibitor (Cyanopyrrolidine Gliptin).
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).
Representative Indian Market Examples (Edition 2.7 Ch 04 [4.3], p. 46): Galvus (Novartis), Zomelis (Abbott), Jalra (USV), Vysov (Emcure); In FDC with Metformin: Galvus Met, Zomelis Met, Jalra-M — Strengths & Dosage Forms: Oral Uncoated Tablets: 50 mg; Sustained-Release (SR/OD): 100 mg SR
Oral Uncoated Tablets: 50 mg; Sustained-Release (SR/OD): 100 mg SR
3. Mechanism of Action & Pharmacodynamics
Dipeptidyl Peptidase-4 (DPP-4) Inhibitor (Cyanopyrrolidine Gliptin) 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) Inhibitor (Cyanopyrrolidine Gliptin) for Type 2 diabetes mellitus as monotherapy or in combination with metformin, sulfonylureas, SGLT2 inhibitors, or insulin..
4. Therapeutic Indications & Evidence-Supported Uses
- Type 2 diabetes mellitus as monotherapy or in combination with metformin, sulfonylureas, SGLT2 inhibitors, or insulin
🇮🇳 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: General Adult Reference: 50 mg twice daily (morning and evening) as monotherapy or with Metformin/TZD/Insulin; 50 mg ONCE daily (morning) when combined with a Sulfonylurea (to prevent hypoglycaemia) or in moderate/severe renal impairment.
Administration & Meal Timing: With or without food (if FDC with metformin, take WITH breakfast and dinner). | Twice daily (morning and evening) for 50 mg IR; once daily in the morning if eGFR <50 mL/min or if 100 mg SR.
6. Pharmacokinetics, Metabolism & Renal/Hepatic Adjustment
Absorption, distribution, metabolism, and excretion follow class pharmacokinetic profile; verify patient renal/hepatic function.
Renal: Mild impairment (eGFR >=50 mL/min): 50 mg BD. Moderate or Severe impairment (eGFR <50 mL/min) or ESRD on haemodialysis: Reduce to 50 mg ONCE DAILY (50% dose reduction). Hepatic: CONTRAINDICATED in baseline hepatic impairment or if pre-treatment ALT or AST >3x ULN. Mandatory LFT monitoring at baseline, every 3 months during Year 1, and periodically thereafter; withdraw permanently if transaminases >=3x ULN persist or jaundice develops.
Renal: Mild impairment (eGFR >=50 mL/min): 50 mg BD. Moderate or Severe impairment (eGFR <50 mL/min) or ESRD on haemodialysis: Reduce to 50 mg ONCE DAILY (50% dose reduction). Hepatic: CONTRAINDICATED in baseline hepatic impairment or if pre-treatment ALT or AST >3x ULN. Mandatory LFT monitoring at baseline, every 3 months during Year 1, and periodically thereafter; withdraw permanently if transaminases >=3x ULN persist or jaundice develops.
Renal: Mild impairment (eGFR >=50 mL/min): 50 mg BD. Moderate or Severe impairment (eGFR <50 mL/min) or ESRD on haemodialysis: Reduce to 50 mg ONCE DAILY (50% dose reduction). Hepatic: CONTRAINDICATED in baseline hepatic impairment or if pre-treatment ALT or AST >3x ULN. Mandatory LFT monitoring at baseline, every 3 months during Year 1, and periodically thereafter; withdraw permanently if transaminases >=3x ULN persist or jaundice develops.
7. Contraindications, Precautions & High-Risk Warnings
- Contraindicated in hepatic impairment, including pre-treatment ALT or AST >3x Upper Limit of Normal (ULN), Type 1 diabetes, and DKA. Caution in NYHA Class III–IV heart failure.
Key Clinical Precautions: Renal: Mild impairment (eGFR >=50 mL/min): 50 mg BD. Moderate or Severe impairment (eGFR <50 mL/min) or ESRD on haemodialysis: Reduce to 50 mg ONCE DAILY (50% dose reduction). Hepatic: CONTRAINDICATED in baseline hepatic impairment or if pre-treatment ALT or AST >3x ULN. Mandatory LFT monitoring at baseline, every 3 months during Year 1, and periodically thereafter; withdraw permanently if transaminases >=3x ULN persist or jaundice develops.
8. Adverse Effects Profile
- Dizziness, headache, mild tremor, asthenia, nasopharyngitis, constipation; low hypoglycaemia risk unless paired with a sulfonylurea/insulin.
- Drug-induced hepatotoxicity / transaminase elevation (>3x ULN) or hepatitis, acute pancreatitis, bullous pemphigoid, angioedema (increased risk with concurrent ACE inhibitors like ramipril/enalapril), severe arthralgia.
- Monitor for severe hypersensitivity, organ toxicity, or dose-limiting adverse events.
9. Major Drug–Drug, Drug–Food & Drug–Herb Interactions
- Low CYP450 interaction potential (hydrolysed primarily via non-CYP pathways)
- Co-administration with ACE inhibitors increases risk of angioedema
- Increases hypoglycaemia risk with sulfonylureas/insulin
10. Clinical Monitoring, Patient Counselling & Storage
Clinical & Laboratory Monitoring: Monitor clinical response, baseline renal/hepatic parameters, and relevant serum biomarkers.
Pharmacist Patient Counselling Points:
- Patient Counselling Checklist: Remind the patient that standard vildagliptin 50 mg is taken twice daily (unlike sitagliptin or teneligliptin 20 mg which are usually once daily), unless reduced for kidney function. Advise reporting unexplained nausea, dark urine, yellowing of eyes, or severe upper abdominal pain immediately.
- Meal & Clock Timing Instruction: With or without food (if FDC with metformin, take WITH breakfast and dinner). (Twice daily (morning and evening) for 50 mg IR; once daily in the morning if eGFR <50 mL/min or if 100 mg SR.)
- Missed Dose Protocol: Take as soon as remembered unless within 4–6 hours of the next scheduled dose; never double.
- Geriatric Dispensing Pearl: Verify baseline LFT and eGFR in elderly patients; if eGFR is <50 mL/min, only a single 50 mg morning tablet should be taken daily.
Storage, Stability & Dispensing Safeguards: Store below 25°C–30°C in original moisture- and light-resistant packaging out of reach of children. Available forms: Oral Uncoated Tablets: 50 mg; Sustained-Release (SR/OD): 100 mg SR
11. Visual Pharmacology & Mechanism Diagram (svg-v339-01-adme-12-step-journey)
12. Authoritative References, Regulatory Sources & Editorial Disclaimer
Primary Compendial & Guideline Reference: Indian Pharmacist Desk Reference — Professional Edition 2.7 (2026–27) • Ch 04 [4.3] (p. 46)
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: HANDBOOK_SOURCE_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
💊 Related Pharmacological / Category Profiles
- [4.17] Linagliptin — Dipeptidyl Peptidase-4 (DPP-4) Inhibitor — Biliary/Non-Renally Cl
- [4.18] Saxagliptin & Alogliptin — Dipeptidyl Peptidase-4 (DPP-4) Inhibitors (Schedule H)
- [4.19] Repaglinide — Short-Acting Meglitinide Prandial Insulin Secretagogue (Schedule
- [4.20] Voglibose — Intestinal Alpha-Glucosidase Inhibitor (Schedule H)
