Vildagliptin with metformin

Dose should be individualised on the basis of the patient's current regimen, effectiveness and tolerability, without exceeding 100 mg vildagliptin daily; the combination may be initiated at either the 50 mg/850 mg or 50 mg/1000 mg strength twice daily. For patients inadequately controlled on their maximal tolerated dose of metformin monotherapy: the starting dose should provide vildagliptin 50 mg twice daily (100 mg total daily) plus the dose of metformin already being taken. For patients switching from co-administration of vildagliptin and metformin as separate tablets: initiate at the doses of each already being taken. For patients inadequately controlled on metformin plus a sulphonylurea, or on insulin plus maximal tolerated metformin: provide vildagliptin 50 mg twice daily and a metformin dose similar to that already being taken; with a sulphonylurea, consider a lower sulphonylurea dose to reduce hypoglycaemia risk. Safety and efficacy as triple oral therapy with a thiazolidinedione have not been established. The maximum daily metformin dose should preferably be divided into 2–3 daily doses. If no adequate fixed-dose strength is available, use the individual monocomponents instead. Assess GFR before initiation and at least annually thereafter (every 3–6 months in the elderly and those at increased risk of progressive renal impairment). Elderly (65 years and over): monitor renal function regularly. Hepatic impairment: should not be used, including pre-treatment ALT or AST greater than 3x the upper limit of normal. Paediatric: not recommended in children and adolescents under 18 years — safety and efficacy not established, no data available. Source: eMC SPC for Eucreas 50 mg/1000 mg film-coated tablets.