Adults: When used as monotherapy, in combination with metformin, in combination with thiazolidinedione, in combination with metformin and a sulphonylurea, or in combination with insulin (with or without metformin), the recommended daily dose of vildagliptin is 100 mg, administered as one dose of 50 mg in the morning and one dose of 50 mg in the evening.
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.
When used in combination with a sulphonylurea, a lower dose of the sulphonylurea may be considered to reduce the risk of hypoglycaemia.
Doses higher than 100 mg are not recommended.
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.
The safety and efficacy of vildagliptin as triple oral therapy in combination with metformin and a thiazolidinedione have not been established.
Additional information on special populations: Elderly (≥65 years): No dose adjustments are necessary in elderly patients (see Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions).
Renal impairment: No dose adjustment is required in patients with mild renal impairment (creatinine clearance ≥50 ml/min). In patients with moderate or severe renal impairment or with end-stage renal disease (ESRD), the recommended dose of Galvus is 50 mg once daily (see Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions and Precautions).
Hepatic impairment: Galvus should not be used in patients with hepatic impairment, including patients with pre-treatment alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3x the upper limit of normal (ULN) (see Pharmacology: Pharmacokinetics under Actions and Precautions).
Paediatric population: Galvus is not recommended for use in children and adolescents (< 18 years). The safety and efficacy of Galvus in children and adolescents (< 18 years) have not been established. No data are available (see Pharmacology: Pharmacodynamics under Actions).
Method of administration: Oral use: Galvus can be administered with or without a meal (see Pharmacology: Pharmacokinetics under Actions).