Vilgalin Met

Vilgalin Met 50 mg/500 mg:

each film-coated tablet contains:

• Vildagliptin 50 mg
• Metformin hydrochloride BP 500 mg

Excipients q.s.

Dyes: titanium dioxide BP, iron oxide (yellow) USP NF

Vilgalin Met 50 mg/850 mg:

each film-coated tablet contains:

• Vildagliptin 50 mg
• Metformin hydrochloride BP 850 mg

Excipients q.s.

Dyes: titanium dioxide BP, iron oxide (yellow) USP NF

Vilgalin Met 50 mg/1000 mg:

each film-coated tablet contains:

• Vildagliptin 50 mg
• Metformin hydrochloride BP 1000 mg

Excipients q.s.

Dyes: titanium dioxide BP, iron oxide (yellow) USP NF

• as an adjunct to diet therapy and exercise, to improve glycemic control in type 2 diabetes mellitus when metformin or vildagliptin monotherapy is insufficiently effective;
• in combination with a sulfonylurea (triple therapy) as an adjunct to diet therapy and exercise to improve glycemic control in type 2 diabetes mellitus in patients previously treated with metformin and sulfonylurea derivatives without achieving adequate glycemic control;
• in combination with insulin as an adjunct to diet therapy and exercise to improve glycemic control in type 2 diabetes mellitus in patients previously treated with insulin therapy at a stable dose and metformin without achieving adequate glycemic control.

When using the drug for type 2 diabetes mellitus as an antihyperglycemic agent, its dose is selected individually, taking into account effectiveness and tolerability. When prescribing Vilgalin Met, the maximum daily dose of vildagliptin (100 mg) should not be exceeded.

The recommended starting dose of Vilgalin Met should be based on the patient’s condition and/or the appropriate dose of vildagliptin and/or metformin hydrochloride that the patient is currently taking. To avoid side effects of metformin hydrochloride on the gastrointestinal tract, Vilgalin Met should be taken with meals.
If a dose of Vilgalin Met is missed, it must be taken as soon as the patient remembers. A double dose should not be taken on the same day.

• For patients whose condition is not adequately controlled on metformin monotherapy, the initial dose of Vilgalin Met should be vildagliptin 50 mg twice daily (100 mg daily dose) plus the patient’s previous dose of metformin.
• For patients who are switching from combination treatment with vildagliptin and metformin as separate drugs, Vilgalin Met should be taken based on the dose of vildagliptin or metformin the patient is already taking.
• For patients whose condition is not adequately controlled on a dual combination with metformin and a sulfonylurea, the dose of Vilgalin Met should be vildagliptin 50 mg twice daily (100 mg daily dose) and the patient’s previous dose of metformin. If Vilgalin Met is taken in combination with a sulfonylurea, lower doses of the sulfonylurea should be considered to reduce the risk of hypoglycemia.
• For patients whose condition is not adequately controlled on a dual combination with insulin and the maximum tolerated dose of metformin, the dose of Vilgalin Met should be vildagliptin 50 mg twice daily (100 mg daily dose) and the patient’s previous dose of metformin.

The safety and effectiveness of vildagliptin and metformin as part of triple combination therapy with a thiazolidinedione have not been established.

Patients with impaired renal function:

Dose adjustment of Vilgalin Met may be required in patients with renal failure with a creatinine clearance of 60 – 90 ml/min (this can be calculated using the Cockcroft-Gault formula based on serum creatinine levels). Vilgalin Met is contraindicated in patients with creatinine clearance <60 ml/min.

Patients with impaired liver function:

It is not recommended to prescribe Vilgalin Met to patients with clinical or laboratory manifestations of liver failure, including in cases where, before starting treatment, ALT or AST activity is more than 3 times the upper limit of normal.

Elderly patients (≥ 65 years):

Since metformin is excreted by the kidneys, and in old age there is a tendency for their function to decline, it is necessary to regularly monitor the functional state of the kidneys during treatment with Vilgalin Met in patients of this age category. The dosage of Vilgalin Met for elderly patients ≥ 65 years of age should be adjusted based on renal function.

Pediatric patients:

The safety and effectiveness of Vilgalin Met in children have not been established. Therefore, it is not recommended to prescribe Vilgalin Met to patients under 18 years of age.