The dose of antihyperglycaemic therapy with Galvus Met 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. Galvus Met may be initiated at either the 50 mg/500 mg, 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 Galvus Met 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: Galvus Met 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 Galvus Met 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 Galvus Met is used in combination with a sulphonylurea, a lower dose of the sulphonylurea may be considered to reduce the risk of hypoglycaemia.
For patients inadequately controlled on dual combination therapy with insulin and the maximal tolerated dose of metformin: The dose of Galvus Met 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.
For treatment naive patients, Galvus Met may be initiated at 50mg/500mg once daily and gradually titrated to a maximum dose of 50mg/1000mg twice daily after assessing the adequacy of therapeutic response.
The safety and efficacy of vildagliptin and metformin as triple oral therapy in combination with a thiazolidinedione have not been established.
Taking Galvus Met with or just after food may reduce gastrointestinal symptoms associated with metformin (see also Pharmacology: PHARMACOKINETICS under Actions).
Patients with renal impairment: A GFR should be assessed before initiation of treatment with metformin-containing products (such as Galvus Met) and at least annually thereafter. In patients at an increased risk of further progression of renal impairment and in the elderly, renal function should be assessed more frequently, e.g. every 3 to 6 months.
The maximum daily dose of metformin should preferably be divided into 2 to 3 daily doses. Factors that may increase the risk of lactic acidosis (see PRECAUTIONS) should be reviewed before considering initiation of metformin-containing products (such as Galvus Met) in patients with GFR<60ml/min.
If no adequate strength of Galvus Met is available, individual monocomponents should be used instead of the fixed dose combination. (See Table 1.)
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Patients with hepatic impairment: Galvus Met should not be used in patients with hepatic impairment, including those with pre-treatment aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times the upper limit of normal (ULN) (see CONTRAINDICATIONS, PRECAUTIONS and ADVERSE REACTIONS).
Elderly (≥65 years): As metformin is excreted via the kidney, and elderly patients have a tendency to decreased renal function, elderly patients taking metformin-containing products (such as Galvus Met) should have their renal function monitored regularly (see PRECAUTIONS and Pharmacology: PHARMACOKINETICS under Actions).
Paediatric patients (< 18 years): Galvus Met is not recommended for use in children and adolescents (< 18 years). The safety and efficacy of Galvus Met in children and adolescents (< 18 years) have not been established. No data are available.