Schedule H

Oral

• Teneligliptin 20 mg tablet

• Fixed-dose combinations (FDCs):

• Teneligliptin 20 mg + Metformin 500 mg IR/SR

• Teneligliptin 20 mg + Metformin 1000 mg SR

• Teneligliptin 20 mg + Dapagliflozin 5 mg

• Teneligliptin 20 mg + Dapagliflozin 10 mg

• Teneligliptin 20 mg + Pioglitazone 15 mg

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Type 2 Diabetes Mellitus (T2DM) — Monotherapy

When diet, exercise, and lifestyle modifications are insufficient for glycaemic control

Parameter Recommendation

Starting dose 20 mg once daily orally

Titration Not usually required

Usual maintenance dose 20 mg once daily

Maximum dose 40 mg once daily (specialist discretion only)

Clinical Notes:

• May be administered without regard to meals

• Suitable first-line option when Metformin is contraindicated or not tolerated

1. Type 2 Diabetes Mellitus — Add-on Therapy

In combination with Metformin, Sulfonylurea, Thiazolidinedione, SGLT2 inhibitor, or Insulin

Parameter Recommendation

Starting dose 20 mg once daily orally

Titration Not usually required

Usual maintenance dose 20 mg once daily

Maximum dose 40 mg once daily (specialist discretion only)

Clinical Notes:

• When adding to Sulfonylurea or Insulin: Consider reducing SU/insulin dose by 20–30% to minimise hypoglycaemia risk

• No additional glycaemic benefit observed with insulin dose escalation after Teneligliptin addition

• Usually well-tolerated in Indian patients

1. FDC Use (Teneligliptin + Metformin)

Parameter Recommendation

Starting dose Based on prior individual therapy; typically 20 mg + 500 mg once or twice daily

Titration Adjust Metformin component based on GI tolerance

Usual maintenance dose 20 mg + 500–1000 mg SR once or twice daily

Maximum dose 20 mg + 2000 mg Metformin daily (in divided doses)

Clinical Notes:

• Adjust Metformin per renal function (avoid if eGFR <30)

• Teneligliptin component does not require renal adjustment

Secondary Indications — Adults (Off-label, if any)

Not routinely used off-label in India. No established off-label indications with supporting evidence in Indian practice.

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

Not applicable.

• Teneligliptin is NOT approved for use in individuals below 18 years of age in India

• Safety and efficacy have not been established in paediatric population

Secondary Indications — Paediatric doses (Off-label, if any)

Parameter Details

Indication Not routinely used

Dose Not established

Evidence basis Limited international data in adolescents; no Indian approval or published Indian trials

Statement: Not recommended in children or adolescents under 18 years. Use only in clinical trial settings or under paediatric endocrinologist supervision with appropriate informed consent.

Clinical Notes:

• One of the few DPP-4 inhibitors not requiring dose reduction in any stage of CKD

• Suitable alternative when Metformin is contraindicated due to renal impairment

• Administer after dialysis session if practical

• Known hypersensitivity to Teneligliptin or any excipient

• Type 1 Diabetes Mellitus

• Diabetic Ketoacidosis (DKA)

• Severe hepatic impairment (Child-Pugh C)

• History of serious hypersensitivity reaction to any DPP-4 inhibitor (angioedema, anaphylaxis)

• Hypoglycaemia risk: Increased when combined with Sulfonylureas or Insulin — consider dose reduction of concomitant agent

• Pancreatitis: Discontinue immediately if acute pancreatitis is suspected; do not restart if confirmed

• Heart failure: Limited data in NYHA Class III–IV heart failure — avoid in unstable or decompensated heart failure

• History of pancreatitis: Use with heightened vigilance

• Not a substitute for insulin in insulin-requiring patients (e.g., during acute illness, surgery, or pregnancy)

Parameter Details

Overall safety Limited human data; animal studies do not indicate direct harm but insufficient for human safety assurance

Recommendation Not recommended unless benefit clearly outweighs risk

Preferred alternative Insulin (first-line for glycaemic control in pregnancy)

If used (specialist only) Monitor maternal glucose and fetal growth carefully

Monitoring Regular FBG, PPBG, HbA1c; fetal ultrasound for growth assessment

Parameter Details

Compatibility Unknown — insufficient human lactation data

Excretion in milk Unknown whether excreted in human breast milk

Recommendation Avoid during breastfeeding

Preferred alternatives Insulin, Metformin (if appropriate)

Infant monitoring (if used) Signs of hypoglycaemia, feeding behaviour, weight gain

Parameter Recommendation

Starting dose 20 mg once daily (same as adults)

Titration Slower titration generally not required

Special considerations Monitor renal function periodically; increased sensitivity to hypoglycaemia if combined with SU/insulin

Additional risks Falls secondary to hypoglycaemia; ensure adequate hydration

Interacting Drug Effect Management

Sulfonylureas ↑ Risk of hypoglycaemia Reduce SU dose by 20–30% when initiating Teneligliptin

Insulin ↑ Risk of hypoglycaemia Reduce insulin dose; monitor glucose closely

Digoxin Possible ↑ digoxin levels (P-gp substrate) Monitor digoxin levels if dose changes occur; clinical significance is minor

Interacting Drug Effect Management

Rifampicin ↓ Teneligliptin efficacy (CYP3A4/P-gp induction) Monitor glycaemic control; may need alternative antidiabetic

Carbamazepine, Phenytoin ↓ Teneligliptin efficacy (enzyme induction) Monitor glucose closely during concurrent use

Other antidiabetics Additive glucose-lowering effect Monitor HbA1c, FBG; adjust doses as needed

ACE inhibitors Possible ↑ risk of angioedema (rare, class effect) Monitor for facial/airway swelling

No significant interaction with: Warfarin, Statins, Amlodipine, common antihypertensives

• Nasopharyngitis / upper respiratory tract infection

• Headache

• Gastrointestinal upset (mild nausea, flatulence, constipation)

• Dizziness

• Hypoglycaemia (when combined with SU or insulin)

Adverse Effect Notes

Acute pancreatitis Rare; discontinue immediately if suspected (persistent severe abdominal pain)

Hypersensitivity reactions Rash, urticaria, angioedema (rare) — discontinue if severe

Hepatic enzyme elevation Monitor LFTs if hepatotoxicity symptoms appear

Severe hypoglycaemia Especially in combination with SU/insulin; may require hospitalisation

Bullous pemphigoid Rare; discontinue if blistering skin lesions develop

After initiation (1–2 weeks) Capillary glucose monitoring; assess for hypoglycaemia if on SU/insulin

3 months HbA1c to assess glycaemic response

Long-term HbA1c every 3–6 months; annual renal function; LFTs if symptoms suggest hepatotoxicity

If pancreatitis suspected Serum amylase, lipase; imaging if indicated

Single-ingredient (Teneligliptin 20 mg):

• Teneliglip®

• Tenepure®

• Tenlimac®

• Teneza®

• Tenglyn®

• Dynaglipt®

• Ziten®

• Tenliday®

FDC brands (Teneligliptin + Metformin):

• Tenepure-M®

• Teneza-M®

• Tenglyn-M®

• Ziten-M®

FDC brands (Teneligliptin + Dapagliflozin):

• Available under various brand names (recent approvals)

Note: Not currently listed under NLEM price control.

1. Renal safety advantage: Teneligliptin is a preferred DPP-4 inhibitor in CKD patients (including those on dialysis) as no dose adjustment is required at any eGFR level.

1. Cost-effectiveness: Among the most affordable DPP-4 inhibitors in the Indian market — significantly cheaper than Sitagliptin, Linagliptin, or Vildagliptin.

1. Low hypoglycaemia risk: When used as monotherapy or with Metformin, hypoglycaemia risk is minimal; reduce SU/insulin dose when adding Teneligliptin.

1. Once-daily, food-independent dosing: Improves adherence, especially in elderly and patients with erratic meal patterns.

1. Weight-neutral: Does not cause weight gain — suitable for overweight/obese T2DM patients.

1. Metformin intolerance: Good alternative first-line agent when Metformin causes intolerable GI side effects.

teneligliptin; DPP-4 inhibitor; type 2 diabetes; T2DM; renal-safe; CKD-friendly; once daily; cost-effective; weight-neutral; India formulary; gliptin

RxIndia v1.0 — 01 Jun 2025

• CDSCO approved product inserts

• Indian Pharmacopoeia

• API Textbook of Medicine (2023 edition)

• ICMR Guidelines for Management of Type 2 Diabetes (2018, updated 2022)

• AIIMS Drug Formulary

• RSSDI Clinical Practice Recommendations for Management of Type 2 Diabetes Mellitus

• Published Indian comparative cost-effectiveness studies

• AIIMS & PGI Hospital Dosing Protocols