Posology : מינונים

4.2    Posology and method of administration

Adults
The management of antidiabetic therapy should be individualized.
The recommended dose of Galvus is 50 mg or 100 mg daily for monotherapy.
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.

When used in combination with metformin, in combination with thiazolidinedione, in combination with metformin and a SU or in combination with insulin (with or without 

GAL API SEP22 V4                                         1                      EU SmPC 07.2022 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 sulfonylurea, 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 sulfonylurea, a lower dose of the sulfonylurea may be considered to reduce the risk of hypoglycaemia.

Daily doses higher than 100 mg are not recommended.

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
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 also sections 4.4, 5.1 and 5.2).

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 also sections 4.4 and 5.2).

Elderly (≥ 65 years)
No dose adjustments are necessary in elderly patients. (see also sections 5.1 and 5.2).

Pediatric population
Galvus is not recommended for use in children and adolescents (< 18 years) due to a lack of data on safety and efficacy.

Method of administration
Oral use
Galvus can be administered with or without a meal (see also section 5.2).