Vildalion-M 550/Vildalion-M 900/Vildalion-M 1050 Dosage/Direction for Use

Posology: Adults with normal renal function (GFR ≥90 mL/min): The dose of antihyperglycemic therapy with Vildagliptin + Metformin should be individualized on the basis of the patient's current regimen, effectiveness and tolerability while not exceeding the maximum recommended daily dose of 100 mg vildagliptin. Vildagliptin + Metformin may be initiated at either the 50 mg/850 mg or 50 mg/1000 mg tablet strength twice daily, one tablet in the morning and the other in the evening.
For patients inadequately controlled at their maximal tolerated dose of metformin monotherapy: The starting dose of Vildagliptin + Metformin should provide vildagliptin as 50 mg twice daily (100 mg total daily dose) plus the dose of metformin already being taken.
For patients switching from co-administration of vildagliptin and metformin as separate tablets: Vildagliptin + Metformin should be initiated at the dose of vildagliptin and metformin already being taken.
For patients inadequately controlled on dual combination with metformin and a sulphonylurea: The doses of Vildagliptin + Metformin should provide vildagliptin as 50 mg twice daily (100 mg total daily dose) and a dose of metformin similar to the dose already being taken. When Vildagliptin + Metformin is used in combination with a sulphonylurea, a lower dose of the sulphonylurea may be considered to reduce the risk of hypoglycemia.
For patients inadequately controlled on dual combination therapy with insulin and the maximal tolerated dose of metformin: The dose of Vildagliptin + Metformin should provide vildagliptin dosed as 50 mg twice daily (100 mg total daily dose) and a dose of metformin similar to the dose already being taken.
The safety and efficacy of vildagliptin and metformin as triple oral therapy in combination with a thiazolidinedione have not been established.
Special populations: Elderly (≥65 years): As metformin is excreted via the kidney, and elderly patients have a tendency to decreased renal function, elderly patients taking Vildagliptin + Metformin should have their renal function monitored regularly.
Renal impairment: A GFR should be assessed before initiation of treatment with metformin-containing products and at least annually thereafter. In patients at increased risk of further progression of renal impairment and in the elderly, renal function should be assessed more frequently, e.g., every 3-6 months.
The maximum daily dose of metformin should preferably be divided into 2-3 daily doses. Factors that may increase the risk of lactic acidosis should be reviewed before considering initiation of metformin in patients with GFR <60 mL/min.
If no adequate strength of Vildagliptin + Metformin is available, individual monocomponents should be used instead of the fixed dose combination. (See Table 1.)

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Hepatic impairment: Vildagliptin + Metformin should not be used in patients with hepatic impairment, including those with pre-treatment alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 times the upper limit of normal (ULN).
Pediatric population: Vildagliptin + Metformin is not recommended for use in children and adolescents (<18 years). The safety and efficacy of Vildagliptin + Metformin in children and adolescents (<18 years) have not been established. No data are available.
Method of administration: Oral use.
Taking Vildagliptin + Metformin with or just after food may reduce gastrointestinal symptoms associated with metformin.