Vilmetfor Tablets 50 mg + 1000 mg

Composition:

Each film-coated tablet contains 50 mg of vildagliptin and 1000 mg of metformin hydrochloride as active ingredients.

Indication:

Vilmetfor is indicated for the treatment of type 2 diabetes mellitus (T2DM).

Vilmetfor is indicated as an adjunct to diet and exercise to improve glycemic control in patients whose diabetes is inadequately controlled with metformin hydrochloride or vildagliptin alone, or in patients already being treated with the combination of vildagliptin and metformin hydrochloride as separate tablets.

Vilmetfor is also indicated for triple combination therapy with a sulfonylurea (SU) in addition to diet and exercise in patients who are inadequately controlled with metformin and a sulfonylurea alone.

Vilmetfor is also indicated as add-on therapy with insulin, in addition to diet and exercise, to improve glycemic control in patients for whom a stable dose of insulin and metformin alone do not provide adequate glycemic control.

Dosage:

Based on the patient’s current dose of metformin, treatment with Vilmetfor may be initiated at 50 mg/850 mg or 50 mg/1000 mg twice daily, one tablet in the morning and one in the evening. Doses exceeding the maximum daily dose of 100 mg of vildagliptin are not recommended.

For patients inadequately controlled on the maximum tolerated dose of metformin monotherapy: Vilmetfor should be given as 50 mg of vildagliptin twice daily (total daily dose 100 mg) in addition to the existing dose of metformin.

Patients already taking vildagliptin and metformin as separate tablets may switch to Vilmetfor containing the same doses of each component.

For patients inadequately controlled on the dual combination of metformin and a sulfonylurea: Vilmetfor should be administered as 50 mg of vildagliptin twice daily (total daily dose 100 mg) and a dose of metformin similar to the one already being taken. When used in combination with a sulfonylurea, a lower dose of the sulfonylurea may be considered to reduce the risk of hypoglycemia.

For patients inadequately controlled on the dual combination of insulin and the maximum tolerated dose of metformin: Vilmetfor should be administered as 50 mg of vildagliptin twice daily (total daily dose 100 mg) and a dose of metformin similar to the one already being taken.

Method of Administration:

For oral use only.

Taking Vilmetfor with or shortly after food may reduce gastrointestinal symptoms associated with metformin.

If a dose is missed, it should be taken as soon as remembered. Do not take a double dose on the same day.

Storage:

Store at a temperature not exceeding 25°C.