The use of antihyperglycaemic therapy in the management of type 2 diabetes should be individualized on the basis of effectiveness and tolerability. In using Galvus Met, do not exceed the maximum daily dose of vildagliptin (100 mg).
The recommended starting dose of Galvus Met should be based on the patient’s condition and/or current regimen of vildagliptin and/or metformin hydrochloride. Galvus Met should be given with meals to reduce the gastrointestinal side effects associated with metformin HCl.
Patients Inadequately Controlled on Vildagliptin Monotherapy: Based on the usual starting doses of metformin HCl (500 mg twice daily or 850 mg once daily), Galvus Met may be initiated at the 50 mg/500 mg tab strength twice daily and gradually titrated after assessing adequacy of therapeutic response.
Patients Inadequately Controlled on Metformin HCl Monotherapy: Based on the patient's current dose of metformin HCl, Galvus Met may be initiated at either 50 mg/500 mg, 50 mg/850 mg or 50 mg/1000 mg tab strength twice daily.
Patients Switching from Combination Therapy of Vildagliptin plus Metformin HCl as Separate Tablets: Galvus Met may be initiated with either the 50 mg/500 mg, 50 mg/850 mg or 50 mg/1000 mg tablet strength based on the dose of vildagliptin or metformin already being taken.
Starting Dose for Treatment Naive Patients: In treatment for naive patients, Galvus Met may be initiated at 50 mg/500 mg once daily and gradually titrated to a maximum dose of 50 mg/1000 mg twice daily after assessing adequacy of therapeutic response.
In Combination with SU or Insulin: 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.
Elderly: As metformin is excreted via the kidney, and elderly patients have a tendency to decreased renal function, elderly patients taking 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).
Patients with Renal Impairment: Galvus Met should not be used in patients with renal failure or renal dysfunction eg, serum creatinine levels ≥1.5 mg/dL (>135 micromol/L) in males and ≥1.4 mg/dL (>110 micromol/L) in females (see Contraindications and Precautions).
Patients with Hepatic Impairment: Galvus Met is not recommended in patients with clinical or laboratory evidence of hepatic impairment including patients with a pre-treatment ALT or AST >2.5 x ULN. (See Precautions.)