A fixed-dose combination (FDC) oral antidiabetic agent containing Metformin Hydrochloride (a biguanide) and Vildagliptin (a dipeptidyl peptidase-4 inhibitor). This combination provides complementary mechanisms of action to improve glycemic control in type 2 diabetes mellitus (T2DM) by reducing hepatic glucose production, increasing insulin sensitivity, and enhancing glucose-dependent insulin secretion while suppressing glucagon secretion. It is a second-line or add-on therapy when monotherapy with metformin is insufficient.
Adult: One tablet (Metformin 500mg + Vildagliptin 50mg) twice daily, with meals. The dose may be titrated based on glycemic control and tolerability, up to a maximum of Metformin 2000mg + Vildagliptin 100mg per day (e.g., two tablets twice daily of this strength).
Note: Swallow whole with a glass of water during or immediately after meals (breakfast and dinner) to reduce gastrointestinal side effects. Do not crush or chew. Maintain adequate fluid intake.
The combination works via two distinct pathways. Metformin decreases hepatic gluconeogenesis, increases peripheral glucose uptake and utilization, and may delay intestinal glucose absorption. Vildagliptin inhibits the enzyme dipeptidyl peptidase-4 (DPP-4), which degrades the incretin hormones glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). This inhibition increases active incretin levels, leading to enhanced glucose-dependent insulin secretion from pancreatic beta cells and suppressed glucagon secretion from alpha cells.
Pregnancy: Category C (US FDA). Not recommended during pregnancy. Insulin is the preferred therapy for glycemic control in pregnant women with diabetes. Limited human data; use only if potential benefit justifies potential fetal risk.
Driving: Usually no effect. However, patients should be cautioned about the risk of dizziness, which may affect the ability to drive or operate machinery, especially at initiation of therapy.
| Iodinated Contrast Media | Risk of lactic acidosis and acute renal failure. Metformin must be withheld. | High |
| Alcohol | Potentiates metformin's effect on lactate metabolism; increased risk of lactic acidosis and hypoglycemia. | High |
| Cimetidine | Increases metformin plasma concentration via competition for renal tubular secretion. | Moderate |
| Corticosteroids, Diuretics, Sympathomimetics | May lead to hyperglycemia, requiring dose adjustment. | Moderate |
| Sulfonylureas or Insulin | Increased risk of hypoglycemia; may require dose reduction of sulfonylurea/insulin. | Moderate |
| ACE Inhibitors, ARBs, NSAIDs | May alter renal function, affecting metformin excretion. | Moderate |
Same composition (Metformin (500mg) + Vildagliptin (50mg)), different brands: