Schedule H

Oral

• Tablet: 50 mg

• Tablet (FDC with Metformin): 50 mg/500 mg

• Tablet (FDC with Metformin): 50 mg/850 mg

• Tablet (FDC with Metformin): 50 mg/1000 mg

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

Type 2 Diabetes Mellitus — in adults for glycaemic control

Indicated when diet and exercise alone are inadequate, either as monotherapy (when metformin is contraindicated or not tolerated) or in combination with other antidiabetic agents.

Monotherapy (when metformin unsuitable)

Parameter Recommendation

Starting dose 50 mg once daily

Titration May increase to 50 mg twice daily after 4 weeks based on glycaemic response

Usual maintenance dose 50 mg twice daily

Maximum dose 100 mg/day

Clinical notes Avoid monotherapy if baseline ALT or AST >2.5× ULN; modest HbA1c reduction (~0.5–0.8%); weight-neutral

Dual Therapy with Metformin (separate tablets or FDC)

Parameter Recommendation

Starting dose 50 mg twice daily added to existing metformin dose

Titration Not usually required; assess response at 12 weeks

Usual maintenance dose 50 mg twice daily (with metformin 500–1000 mg twice daily)

Maximum dose Vildagliptin 100 mg/day

Clinical notes FDC options available for improved compliance; maintain metformin at tolerated dose

Combination with Sulfonylurea

Parameter Recommendation

Starting dose 50 mg once daily (added to existing sulfonylurea)

Titration Generally not required

Usual maintenance dose 50 mg once daily

Maximum dose 50 mg/day when combined with SU

Clinical notes Consider reducing sulfonylurea dose to minimize hypoglycaemia risk

Triple Therapy (Metformin + Sulfonylurea + Vildagliptin)

Parameter Recommendation

Starting dose 50 mg once daily

Titration Not usually required

Usual maintenance dose 50 mg once daily

Maximum dose 50 mg/day

Clinical notes Higher hypoglycaemia risk; may need SU dose reduction; close glucose monitoring required

Add-on to Insulin (with or without Metformin)

Parameter Recommendation

Starting dose 50 mg twice daily

Titration Not required

Usual maintenance dose 50 mg twice daily

Maximum dose 100 mg/day

Clinical notes May require insulin dose reduction to avoid hypoglycaemia; monitor closely

Secondary Indications — Adults (Off-label)

Not applicable — No established off-label indications in Indian guidelines or specialist practice.

PAEDIATRIC DOSING (Specialist Only)

Primary Indications

Not applicable — Vildagliptin is NOT approved for use in children or adolescents below 18 years of age. Safety and efficacy have not been established in the paediatric population.

Secondary Indications — Paediatrics (Off-label)

Not applicable — No established off-label paediatric indications.

Age Restriction: Not recommended below 18 years of age. Use only in exceptional circumstances under paediatric endocrinologist supervision with documented justification.

50 No dose adjustment required

30–50 50 mg once daily

<30 (including ESRD) Avoid use — limited safety data; drug and metabolites are renally excreted

Haemodialysis Not recommended — not dialyzable

Peritoneal dialysis Not recommended — limited data

Note: When using FDC with metformin, metformin contraindications in renal impairment apply (avoid if eGFR <30).

Baseline ALT/AST >2.5× ULN Avoid use — do not initiate therapy

• Known hypersensitivity to vildagliptin or any excipient

• Severe hepatic impairment (Child-Pugh C)

• Baseline ALT or AST >3× upper limit of normal

• History of pancreatitis associated with DPP-4 inhibitor use

• Type 1 diabetes mellitus

• Diabetic ketoacidosis

• Concurrent use with GLP-1 receptor agonists (overlapping mechanism)

• Pre-existing liver disease or elevated transaminases — requires close LFT monitoring

• Heart failure (NYHA Class III–IV) — use with caution; increased monitoring advised

• Moderate renal impairment — dose reduction required

• Elderly patients — increased susceptibility to adverse effects

• History of pancreatitis (non-DPP-4 related) — monitor for recurrence

• Combination with sulfonylureas or insulin — increased hypoglycaemia risk

Parameter Recommendation

Risk category Limited human data; animal studies did not show teratogenicity; safety not established

Preferred alternatives Insulin (first choice); metformin (acceptable under specialist guidance in Indian obstetric practice)

When it may be used Only if potential benefit clearly outweighs risk — requires specialist diabetologist/obstetrician input

What to monitor Maternal glycaemic control (fasting and postprandial glucose, HbA1c); fetal growth via ultrasound

Parameter Recommendation

Compatibility Not recommended — excretion in human milk unknown

Expected drug levels in milk Unknown

Preferred alternatives Insulin (no systemic absorption in infant); metformin (low milk levels, generally acceptable)

What to monitor in infant If inadvertently used: feeding adequacy, weight gain, signs of hypoglycaemia

Parameter Recommendation

Starting dose 50 mg once daily (especially if renal function borderline or eGFR 30–50)

Titration Slower — assess response and tolerability over 4–8 weeks before increasing

Key risks Reduced renal reserve (check eGFR before dosing); higher risk of hepatic adverse events; hypoglycaemia (especially if combined with SU or insulin); falls and dehydration

Monitoring Renal function every 6 months; LFTs quarterly in first year; glucose monitoring if on combination therapy

Interacting Drug Mechanism / Effect Action

Sulfonylureas (glimepiride, gliclazide) Additive hypoglycaemic effect Monitor blood glucose closely; may need to reduce SU dose by 50%

Insulin Additive hypoglycaemic effect Monitor blood glucose; consider reducing insulin dose

ACE inhibitors (enalapril, ramipril) Possible increased risk of angioedema (rare, class effect) Use with awareness; monitor for facial/throat swelling

GLP-1 receptor agonists (liraglutide, dulaglutide) Overlapping incretin mechanism; no additional benefit Avoid combination — not recommended

Hepatotoxic agents (isoniazid, rifampicin, high-dose paracetamol, statins) Additive hepatotoxicity risk Monitor LFTs more frequently; avoid combination if baseline transaminases elevated

Interacting Drug Mechanism / Effect Action

Thiazide diuretics May blunt glucose-lowering effect Monitor glycaemic control; may need antidiabetic dose adjustment

Corticosteroids (prednisolone, dexamethasone) Antagonize hypoglycaemic effect Monitor blood glucose; may require temporary increase in antidiabetic therapy

Rifampicin Weak CYP induction; may slightly reduce vildagliptin efficacy Monitor glycaemic control during TB treatment

Beta-blockers (propranolol, metoprolol) May mask hypoglycaemic symptoms Educate patient on hypoglycaemia recognition; prefer cardioselective agents

Digoxin Minor interaction reported No dose adjustment; monitor if clinical concern arises

• Headache

• Dizziness

• Nasopharyngitis / upper respiratory tract infection

• Peripheral oedema (dose-related)

• Tremor

• Constipation

• Elevated liver enzymes (ALT/AST) — usually asymptomatic

Adverse Effect Clinical Significance

Hepatitis / Hepatotoxicity Elevated transaminases may progress to hepatitis; discontinue immediately if ALT/AST >3× ULN or jaundice develops; refer for hepatology evaluation

Acute pancreatitis Rare but serious; presents with severe abdominal pain radiating to back; discontinue immediately and do not rechallenge

Bullous pemphigoid Immune-mediated blistering skin disorder; requires dermatology referral and drug discontinuation

Angioedema Rare; may occur especially with concurrent ACE inhibitor use; requires immediate discontinuation

Severe hypoglycaemia Primarily when combined with SU or insulin; may require hospitalization

Long-term maintenance LFTs every 3 months during first year, then annually; HbA1c every 3–6 months; eGFR every 6–12 months (more frequently in elderly); monitor for symptoms of pancreatitis

Additional Educate patients to report unexplained nausea, vomiting, abdominal pain, dark urine, or jaundice

Monotherapy (50 mg tablet):

• Galvus (Novartis — originator)

• Jalra (USV)

• Zomelis (Emcure)

• Vysov (Ajanta)

• Vogli (Glenmark)

• Vilda (Torrent)

Fixed-Dose Combinations (Vildagliptin + Metformin):

• Galvus Met (Novartis)

• Jalra M (USV)

• Zomelis Met (Emcure)

• Vysov M (Ajanta)

• Vogli M (Glenmark)

NPPA Status: Not included in NLEM 2022; not currently under DPCO price control. Generic versions widely available at competitive prices.

• Hepatic monitoring is mandatory — check LFTs at baseline and every 3 months during the first year; do not initiate if ALT/AST >2.5× ULN

• Low hypoglycaemia risk as monotherapy — makes it suitable for elderly or patients with erratic eating patterns; however, risk increases significantly when combined with SU or insulin

• Dose reduction required in moderate renal impairment — use 50 mg once daily if eGFR 30–50; avoid if eGFR <30

• Do not combine with GLP-1 receptor agonists — overlapping incretin mechanism provides no additional benefit and may increase adverse effects

• Weight-neutral profile — useful in patients where weight gain is a concern; does not cause weight loss like SGLT2 inhibitors or GLP-1 agonists

• Consider alternatives if hepatic concerns — SGLT2 inhibitors (if no renal contraindication) may be preferable in patients with liver disease history

Vildagliptin; DPP-4 inhibitor; gliptin; type 2 diabetes; oral antidiabetic; hepatotoxicity monitoring; renal dose adjustment; low hypoglycaemia risk; weight-neutral; Schedule H

RxIndia v1.0 — 16 May 2025

• CDSCO — Approved drug information

• Indian Pharmacopoeia / National Formulary of India

• API Textbook of Medicine

• RSSDI Clinical Practice Guidelines for Management of Type 2 Diabetes

• Endocrine Society of India Guidelines

• AIIMS Endocrinology Protocols

• Goodman & Gilman's: The Pharmacological Basis of Therapeutics

• Harrison's Principles of Internal Medicine

• Indian manufacturer package inserts (Galvus, Jalra, Zomelis)