Galvus Met Dosage/Direction for Use

Antidiabetic treatment should be individualized on the basis of effectiveness and tolerability. When using Galvus Met, do not exceed the maximum recommended daily dose of 100 mg vildagliptin.
The recommended starting dose of Galvus Met should be based on the current regimen of vildagliptin and/or metformin.
Starting dose for patients inadequately controlled on vildagliptin monotherapy: Based on the usual starting dose of metformin (daily dose: 500-1000 mg), Galvus Met 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, Galvus Met 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 Galvus Met from the free combination of metformin and vildagliptin: Based on the current dose of metformin or vildagliptin, Galvus Met 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 sulphonylurea: Based on the current dose of metformin, Galvus Met 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 sulphonylurea, a lower dose of the sulphonylurea may be considered to reduce the risk of hypoglycaemia.
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 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<60 ml/min. Galvus Met is contraindicated in patients with GFR <30 ml/min because of its metformin component (see Contraindications).
The following dosing recommendations apply to metformin and vildagliptin, used separately or in combination, in patients with renal impairment. If no adequate strength of Galvus Met is available, individual components should be used instead of the fixed dose combination. (See table.)

Click on icon to see table/diagram/image

Patients with hepatic impairment: Galvus Met is not recommended for use in patients with hepatic dysfunction, including patients with pre-treatment AST or ALT >2.5 × ULN (see Precautions).
Elderly patients: Metformin is excreted via the kidneys, and elderly patients have a tendency to decreased renal function. Therefore, elderly patients taking metformin-containing products (such as Galvus Met) should have their renal function monitored regularly. Galvus Met should only be used in elderly patients with normal renal function (see Contraindications and Precautions).
Children and adolescents: The safety and efficacy of Galvus Met have not been established in patients under 18 years of age. Galvus Met is therefore not recommended for use in paediatric patients.
Method of administration: Oral use.
Galvus Met should be given with meals to reduce the gastrointestinal side effects associated with metformin hydrochloride.
If a dose of Galvus Met is missed, it should be taken as soon as the patient remembers. A double dose should not be taken on the same day.