The management of antidiabetic therapy should be individualized.
Monotherapy: The recommended dose of Galvus is 50 mg or 100 mg daily. The 50 mg dose should be administered once daily in the morning. The 100 mg dose should be administered as two divided doses of 50 mg given in the morning and evening.
Combination therapy: Combination therapy with other antidiabetic drugs such metformin, an SU, a TZD or insulin may be given if a tighter glycaemic control is required on the top of the maximum recommended daily dose of 100 mg Galvus monotherapy.
The recommended dose of Galvus is 50 mg or 100 mg daily in dual combination with metformin, or a TZD or insulin. The 50 mg dose should be administered once daily in the morning. The 100 mg dose should be administered as two divided dose of 50 mg given in the morning and evening.
The recommended dose of Galvus is 50 mg bid for triple combination with metformin and a SU.
When used in dual combination with a sulphonylurea, the recommended dose of vildagliptin is 50 mg once daily administered in the morning. In this patient population, vildagliptin 100 mg daily was no more effective than vildagliptin 50 mg once daily.
Special populations: Hepatic impairment: Galvus is not recommended in patients with hepatic impairment including patients with a pre-treatment ALT or AST >2.5x the upper limit of normal (ULN).
No dosage adjustment of Galvus is required in patients with mild renal impairment. In patients with moderate or severe renal impairment, the recommended dose of Galvus is 50 mg once daily.
Renal impairment: Galvus is, however, not recommended in patients with End Stage Renal Disease (ESRD) on haemodialysis due to limited experience in patients with End Stage Renal Disease (ESRD) on haemodialysis (see also Precautions).
There is limited data on the use of combination therapy in patients with renal and hepatic impairment. Therefore, the use of Galvus in combination therapy is not recommended in these patients.
Geriatrics: In patients treated with Galvus ≥65 years of age and ≥75 years of age, no differences were observed in the overall safety, tolerability, or efficacy between this elderly population and younger patients. No dosage adjustments are therefore necessary in the elderly patients.
Paediatric patients: Galvus has not been studied in patients under 18 years of age; therefore, the use of Galvus in paediatric patients is not recommended.
Method of administration: For oral use.
Galvus can be administered with or without meal.
If a dose of Galvus is missed, it should be taken as soon as the patient remembers. A double dose should not be taken on the same day.