Vildamet® 50/500 Tablet: Each film-coated tablet contains Vildagliptin INN 50 mg and Metformin HCl USP 500 mg.
Vildamet® 50/850 Tablet: Each film-coated tablet contains Vildagliptin INN 50 mg and Metformin HCl USP 850 mg.
Vildamet® 50/1000 Tablet: Each film-coated tablet contains Vildagliptin INN 50 mg and Metformin HCl USP 1000 mg.
Vildamet® is a fixed dose combination of two antihyperglycemic agents with different mechanisms of action. Vildagliptin is a member of the dipeptidyl peptidase 4 (DPP-4) inhibitor class and metformin hydrochloride is a member of the biguanide.
Mode of action:
Vildagliptin inhibits dipeptidyl peptidase 4 (DPP-4), the enzyme responsible for the inactivation of the incretin hormones which are released into the circulation in response to food intake. Inhibition of DPP-4, results in higher levels of active incretin hormones, stimulating insulin release and reducing glucagon release in a glucose dependent manner.
Metformin HCl decreases hepatic glucose production, decreases intestinal absorption of glucose and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.
Pharmacokinetics:
Vildagliptin is rapidly absorbed with peak plasma concentrations observed at 1.75 hours. vildagliptin can be given with or without food. The absolute bioavailability is 85%. The plasma protein binding of vildagliptin is low (9.3%), and vildagliptin distributes equally between plasma and red blood cells. Vildagliptin is not metabolized by cytochrome P450 enzymes. Approximately 85% of the dose excreted into the urine and 15% of the dose recovered in the faeces.
The absolute bioavailability of Metformin HCl at fasting condition is approximately 50-60%. Food decreases the extent and slightly delays the absorption of Metformin HCl. Metformin HCl is negligible bound to plasma proteins in contrast to sulfonylureas. The elimination half-life is approximately 17.6 hours.
Vildamet® is indicated for the treatment of type 2 diabetes mellitus patients who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral Metformin HCl alone or who are already treated with the combination of vildagliptin and Metformin HCl as separate tablets.
Based on the patient’s current dose of Metformin HCl, combination of Vildagliptin & Metformin HCl may be initiated at either 50 mg/500 mg or 50 mg/850 mg or 50 mg/1000 mg twice daily, 1 tablet in the morning and the other in the evening. The recommended daily dose is 100 mg Vildagliptin plus 2000 mg Metformin HCl. Patients receiving Vildagliptin and Metformin HCl from separate tablets may be switched to combination of Vildagliptin & Metformin HCl containing the same doses of each component.
In pharmacokinetic studies, no interactions were seen with pioglitazone, Metformin HCl, glibenclamide, digoxin, warfarin, amlodipine, ramipril, valsartan or simvastatin. As with other oral antidiabetic medicinal products the glucose-lowering effect of Vildagliptin may be reduced by certain active substances, including thiazides, corticosteroids, thyroid products and sympathomimetics. Glucocorticoids, beta-2 agonists, diuretics and ACE inhibitors may alter blood glucose.
Over dosage Symptoms of overdose may include lactic acidosis, muscle pain, fever, oedema.
Pregnancy: There are no adequate data on the use of Vildagliptin & Metformin HCl in pregnant women; hence the potential risk for human is unknown.
Lactation: It is not known whether Vildagliptin is excreted in human milk. Due to lack of human data, Vildagliptin & Metformin HCl should not be used during lactation.
Lactic acidosis can occur due to Metformin HCl accumulation. If metabolic acid.
Keep out of reach of children. Store in a dry, well ventilated premises at temperatures up to 30 C, away from extraneous odors, contamination, and intense light.