GALVUS MET 50/1000/MG TAB 60/TAB

Indications

Approved Uses

Adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with metformin alone is insufficient, or in patients already treated with vildagliptin and metformin as separate tablets; may also be used in combination with other antidiabetic agents (e.g., insulin) where appropriate per local labeling.

Dosage & Administration

Dosing by Condition

Type 2 diabetes mellitus (adults): individualize based on prior therapy; typical regimen is 1 tablet twice daily with meals; maximum vildagliptin 100 mg/day and metformin 2000 mg/day (i.e., for 50/1000 mg strength: 1 tablet BID).

Initial Dose

One tablet (vildagliptin 50 mg/metformin 1000 mg) twice daily with meals; adjust based on prior metformin dose and tolerability.

Maintenance Dose

One tablet (50mg/1000mg) twice daily.

Maximum Dose

100 mg vildagliptin/day and 2000 mg metformin/day (one 50 mg/1000 mg tablet twice daily).

Children's Dosage

Not recommended for use in children and adolescents under 18 years of age.

Dose Adjustment Notes

Assess eGFR before initiation and periodically; contraindicated if eGFR <30 mL/min/1.73 m²; do not initiate if eGFR 30-45 and reassess risk/benefit if eGFR falls below 45 during therapy; temporarily withhold around iodinated contrast or acute illness causing hypoxia/dehydration; titrate metformin component to minimize GI effects.

How to Take

Swallow the film‑coated tablet whole with water; take with meals (typically morning and evening meals) to reduce gastrointestinal adverse effects; do not crush/chew.

Side Effects

Common Side Effects

Common: gastrointestinal effects (nausea, diarrhea, abdominal pain, vomiting, flatulence), headache, dizziness; nasopharyngitis/upper respiratory symptoms may occur; hypoglycaemia is uncommon unless used with insulin or a sulfonylurea.

Side Effect Frequency

Most common adverse effects are gastrointestinal (e.g., nausea, diarrhea, abdominal pain) and headache/dizziness; hypoglycemia is uncommon unless combined with insulin/secretagogues; rare but serious risks include lactic acidosis (metformin, very rare) and pancreatitis/hepatitis/angioedema (vildagliptin, rare).

Safety & Warnings

Contraindications

Contraindicated in: hypersensitivity to metformin or vildagliptin; severe renal impairment (eGFR <30 mL/min/1.73 m²); acute or chronic metabolic acidosis including diabetic ketoacidosis (with or without coma); and hepatic impairment/active liver disease (including baseline ALT/AST >3× ULN-vildagliptin component).

Warnings & Precautions

Monitor renal function before start and periodically; counsel/monitor for lactic acidosis and stop if suspected; temporarily discontinue around iodinated contrast and major surgery/acute illness causing hypoxia or dehydration and restart when renal function stable; monitor liver enzymes (baseline and periodically, especially during first year) and stop if ALT/AST >3× ULN or hepatitis suspected; discontinue if pancreatitis suspected; caution in elderly and in conditions predisposing to hypoxia; not for type 1 diabetes or DKA; watch for bullous pemphigoid and hypersensitivity.

Age Restriction

Not approved under 18 years

Drug Interactions

Drug Interactions

Key interactions/management: alcohol (↑ lactic acidosis risk); iodinated contrast media (temporarily stop metformin and restart after renal function is stable, typically ≥48 h); drugs that reduce renal function or compete for renal tubular secretion (e.g., cimetidine and other cationic drugs) may ↑ metformin exposure; insulin/sulfonylureas (↑ hypoglycemia risk); agents that can worsen glycemic control (e.g., corticosteroids, thiazide/loop diuretics).

Interaction Severity

MAJOR: iodinated contrast media (withhold metformin in at-risk patients/when indicated; restart after renal function stable), excessive alcohol (↑ lactic acidosis risk). MODERATE: insulin/sulfonylureas (↑ hypoglycaemia risk), drugs that impair renal function or cause dehydration (e.g., NSAIDs, diuretics, ACEi/ARBs) (↑ metformin accumulation risk), cationic drugs cleared by tubular secretion (e.g., cimetidine) (↑ metformin levels).

Food Interaction

Take with food.

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Contraindicated

Children

Not recommended for use in children and adolescents under 18 years of age.

Elderly

Use with caution; monitor renal function regularly as elderly patients are at higher risk of renal impairment and lactic acidosis; dose selection should be conservative; avoid in patients ≥80 years unless renal function is confirmed to be normal

Kidney Impairment

eGFR ≥60: usual dosing (max metformin 2000 mg/day; vildagliptin 100 mg/day). eGFR 45-59: continue with monitoring; do not exceed metformin 2000 mg/day; vildagliptin max 100 mg/day. eGFR 30-44: do not initiate; if continuing, limit metformin to ≤1000 mg/day and reduce vildagliptin to 50 mg/day. eGFR <30: contraindicated.

Liver Impairment

Avoid/contraindicated in hepatic impairment or active liver disease; do not initiate (and discontinue) if ALT or AST >3× ULN.

Storage & Patient Advice

Storage Conditions

Do not store above 30°C.

Missed Dose

Take the missed dose as soon as remembered with food; if it is near the time of the next dose, skip the missed dose and resume the regular schedule; do not double doses.

Stopping the Medicine

Do not stop GALVUS MET unless directed by the prescriber; stopping can worsen glycemic control-seek medical advice before discontinuation.

Overdose

Overdose may cause metformin-associated lactic acidosis (e.g., severe nausea/vomiting/abdominal pain, malaise, hypothermia, hypotension, bradyarrhythmias, hyperventilation); treat as emergency-supportive care and consider hemodialysis to remove metformin; vildagliptin overdose data are limited-supportive management.

Patient Counseling

Take with meals (morning/evening) and swallow whole; avoid excessive alcohol; seek urgent care for symptoms of lactic acidosis (e.g., severe weakness, muscle pain, rapid breathing, abdominal pain, persistent vomiting, feeling cold) and report jaundice/dark urine (possible hepatic injury); inform clinicians before contrast imaging/surgery or during severe illness/dehydration; monitor glucose as directed and keep scheduled HbA1c, kidney and (as advised) liver tests; hypoglycaemia risk increases if used with insulin or sulfonylurea.

Monitoring Requirements

Monitor HbA1c about every 3 months until controlled then every 6 months; renal function (eGFR) at baseline and at least annually (more often if elderly/at risk); liver function tests at baseline and periodically (and more frequently early in therapy per local labeling); periodic vitamin B12 with long-term metformin; self-monitor blood glucose as clinically indicated (especially if combined with insulin/sulfonylurea).

Pharmacology

Mechanism of Action

Vildagliptin inhibits DPP-4, increasing endogenous incretins (GLP-1, GIP) to enhance glucose-dependent insulin secretion and suppress glucagon; metformin decreases hepatic gluconeogenesis, reduces intestinal glucose absorption, and improves peripheral insulin sensitivity (via AMPK-related pathways).

Onset of Action

Vildagliptin achieves DPP-4 inhibition within hours (peak effect ~1-3 hours); metformin’s glucose-lowering begins within days, with full glycaemic effect typically over 1-2 weeks (HbA1c impact assessed over ~8-12 weeks).

Duration of Effect

Approximately 12 hours per dose, supporting twice-daily administration for the vildagliptin component (with metformin providing continuous background effect).

Half-Life

Vildagliptin: ~3 hours. Metformin: ~6 hours plasma half-life (with a longer apparent half-life in whole blood due to erythrocyte distribution).

Bioavailability

Vildagliptin oral bioavailability ~85%; metformin absolute bioavailability ~50-60% (fasting; reduced by food).

Metabolism

Vildagliptin: primarily metabolized by hydrolysis (non-CYP) to inactive metabolites. Metformin: not metabolized; excreted unchanged.

Excretion

Metformin: primarily renal excretion, largely unchanged (via glomerular filtration and active tubular secretion). Vildagliptin: predominantly eliminated via the kidneys (majority in urine, largely as metabolites), with a smaller fecal component.

Protein Binding

Vildagliptin: ~9.3%; Metformin: negligible

Product Information

Available Dosage Forms

Film-coated tablet.

Composition per Dose

Each film-coated tablet: Vildagliptin 50mg + Metformin hydrochloride 1000mg

OTC Alternatives

No OTC alternative

Diabetes Type

Type 2

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