Vildamaf-M

Vildamaf-M

COMPOSITION:

Each film coated tablet of Vildamaf-M contains:

Vildagliptin ……………………………………………. 50mf

Metformin HCl ………………….. 850mg & 1000mg

DESCRIPTION:

Vildagliptin: is a selective DPP-4 inhibitor for Type 2 diabetes, working by boosting incretin hormones (GLP-1, GIP) to increase glucose-dependent insulin release and decrease glucagon, improving blood sugar control with low hypoglycemia risk.

Metformin HCl:  is a white, crystalline powder, a biguanide drug used for Type 2 diabetes, known for its high-water solubility, low protein binding, and excretion as unchanged drug via the kidneys.

INDICATIONS:

Patients with type 2 diabetes mellitus (T2DM).

Vildamaf – M is indicated as an adjunct to diet and exercise in patients whose blood glucose is not adequately controlled on Metformin Hydrochloride or Vildagliptin alone, or in patients already being treated with a free combination of Metformin Hydrochloride and Vildagliptin.

Vildamaf – M is indicated in combination with a sulphonylureas (i.e. triple combination therapy) as an adjunct to diet and exercise in patients whose blood glucose is not adequately controlled on Metformin and a sulphonylureas alone.

Vildamaf – M is indicated in combination with insulin to improve glycemic control in patients whose blood glucose cannot be adequately controlled by diet, exercise and treatment with a stable dose of insulin and Metformin.

DOSAGE:

Antidiabetic treatment should be individualized on the basis of effectiveness and tolerability. When using Vildamaf – M, do not exceed the maximum recommended daily dose of 100 mg Vildagliptin.

The recommended starting dose of Vildamaf – M should be based on the current regimen of Vildagliptin and/or Metformin. Vildamaf – M should be given with meals to reduce the gastrointestinal adverse effects of Metformin.

Starting dose for patients inadequately controlled on Vildagliptin monotherapy Based on the usual starting dose of Metformin (daily dose: 500-1000 mg), Vildamaf – M should be initiated at the 50 mg/500 mg or 50 mg/850 mg tablet strength twice daily, with the dose of Metformin being gradually titrated based on an assessment of the therapeutic response.

Starting dose for patients inadequately controlled on Metformin monotherapy.

Based on the current dose of Metformin, Vildamaf – M should be initiated at the 50 mg/500 mg, 50 mg/850 mg or 50 mg/1000 mg tablet strength twice daily.

Starting dose for patients switching to Vildamaf – M from the free combination of Metformin and Vildagliptin.

Based on the current dose of Metformin or Vildagliptin, Vildamaf – M should be initiated at the 50 mg/500 mg, 50 mg/850 mg or 50 mg/1000 mg tablet strength.

Use in combination with insulin or sulphonylureas:

Based on the current dose of Metformin, Vildamaf – M should be taken at the 50 mg/500 mg, 50 mg/850 mg or 50 mg/1000 mg tablet strength twice daily.

When used in combination with a sulphonylureas, a lower dose of the sulphonylureas may be considered to reduce the risk of hypoglycaemia.

Patients with renal impairment:

Vildamaf – M should not be used in patients with renal failure or renal dysfunction (creatinine clearance (<60 ml/minute.

Patients with hepatic impairment:

Vildamaf – M is not recommended for use in patients with hepatic dysfunction, including patients with pre-treatment AST or ALT >2.5 x ULN.

Metformin is excreted via the kidneys, and elderly patients have a tendency to decreased renal function.

Storage Conditions:

– Keep the medicine in a dry place at a temperature below 30 °C.

– Keep the medicine out of the reach of children.

– Protect the medicine from direct sunlight.

– Do not use Vildamaf after expire date.