1. Clinical & Scientific Overview
Teneligliptin Hydrobromide Hydrate (TIP-MED-000048, Reference Code [4.4]) is classified under
Antidiabetic Medicines, Insulins & GLP-1 Agonists (Ch 04) as a Dipeptidyl Peptidase-4 (DPP-4) Inhibitor (Peptidomimetic 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).
Januvia (MSD), Istavel (Sun Pharma), Zita (Glenmark)
Oral Film-Coated Tablets: 20 mg
3. Mechanism of Action & Pharmacodynamics
Dipeptidyl Peptidase-4 (DPP-4) Inhibitor (Peptidomimetic 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 (Peptidomimetic Gliptin) for Type 2 diabetes mellitus as an adjunct to diet and exercise (monotherapy or combination therapy)..
4. Therapeutic Indications & Evidence-Supported Uses
- Type 2 diabetes mellitus as an adjunct to diet and exercise (monotherapy or combination therapy)
🇮🇳 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: 20 mg once daily (may be increased to 40 mg once daily if glycaemic response is inadequate under close monitoring). Follow physician prescription.
Administration & Meal Timing: With or without food (take with meals if FDC with metformin). | Once daily in the morning.
6. Pharmacokinetics, Metabolism & Renal/Hepatic Adjustment
Absorption, distribution, metabolism, and excretion follow class pharmacokinetic profile; verify patient renal/hepatic function.
Renal: Dual hepatorenal elimination (~34% unchanged in urine, ~66% hepatic metabolism) allows 20 mg once daily across all stages of CKD (including severe CKD and haemodialysis) without dose adjustment—a major reason for its widespread prescription in India. Hepatic: Use with caution in mild-to-moderate hepatic impairment; avoid in severe hepatic failure (Child-Pugh C).
Renal: Dual hepatorenal elimination (~34% unchanged in urine, ~66% hepatic metabolism) allows 20 mg once daily across all stages of CKD (including severe CKD and haemodialysis) without dose adjustment—a major reason for its widespread prescription in India. Hepatic: Use with caution in mild-to-moderate hepatic impairment; avoid in severe hepatic failure (Child-Pugh C).
Renal: Dual hepatorenal elimination (~34% unchanged in urine, ~66% hepatic metabolism) allows 20 mg once daily across all stages of CKD (including severe CKD and haemodialysis) without dose adjustment—a major reason for its widespread prescription in India. Hepatic: Use with caution in mild-to-moderate hepatic impairment; avoid in severe hepatic failure (Child-Pugh C).
7. Contraindications, Precautions & High-Risk Warnings
- Contraindicated in Type 1 DM, DKA, and severe hypersensitivity. Specific Cardiac Precaution: Can cause dose-dependent QTc interval prolongation (especially at 40 mg/day or when combined with other QT-prolonging medications); use with caution in patients with bradycardia, heart failure, hypokalaemia, or congenital long QT syndrome.
Key Clinical Precautions: Renal: Dual hepatorenal elimination (~34% unchanged in urine, ~66% hepatic metabolism) allows 20 mg once daily across all stages of CKD (including severe CKD and haemodialysis) without dose adjustment—a major reason for its widespread prescription in India. Hepatic: Use with caution in mild-to-moderate hepatic impairment; avoid in severe hepatic failure (Child-Pugh C).
8. Adverse Effects Profile
- Constipation, abdominal bloating, nasopharyngitis, headache; hypoglycaemia when combined with sulfonylureas.
- QTc prolongation / torsades de pointes (at supraventricular/high doses or with interacting drugs), acute pancreatitis, bullous pemphigoid, hepatic enzyme elevation, interstitial pneumonia (rare).
- Monitor for severe hypersensitivity, organ toxicity, or dose-limiting adverse events.
9. Major Drug–Drug, Drug–Food & Drug–Herb Interactions
- Metabolised via CYP3A4 and flavin-containing monooxygenases (FMO3) alongside renal excretion
- Ketoconazole/itraconazole modestly increase plasma exposure
- Avoid combining with Class IA/III antiarrhythmics (amiodarone, sotalol) or other QT-prolonging drugs (ondansetron, domperidone, fluoroquinolones, escitalopram)
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: Take once daily at the same time each morning. Inform the patient not to exceed the prescribed 20 mg daily tablet without consulting the doctor, and report severe stomach pain or dizzy spells/palpitations.
- Meal & Clock Timing Instruction: With or without food (take with meals if FDC with metformin). (Once daily in the morning.)
- Missed Dose Protocol: Take as soon as remembered on the same day; skip if close to the next day's dose.
- Geriatric Dispensing Pearl: Widely prescribed in CGHS and Jan Aushadhi settings due to low cost and no renal dose adjustment at 20 mg OD; however, pharmacists must screen elderly prescriptions for additive QT-prolonging drugs (such as domperidone, amiodarone, or levofloxacin).
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 Film-Coated Tablets: 20 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 Pharmacist Desk Reference — Professional Edition 2.7 (2026–27) • Ch 04 [4.4] (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
- [4.18] 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)
- [4.21] Semaglutide (Oral & Subcutaneous GLP-1 Receptor Agonist) — Glucagon-Like Peptide-1 (GLP-1) Receptor Agonist (Schedule H)
