Per 50 mg/500 mg FC tab Vildagliptin 50 mg, metformin HCl 500 mg. Per 50 mg/850 mg FC tab Vildagliptin 50 mg, metformin HCl 850 mg. Per 50 mg/1,000 mg FC tab Vildagliptin 50 mg, metformin HCl 1,000 mg
Indications/Uses
Initial therapy in adults w/ type 2 DM inadequately controlled by diet & exercise alone. Type 2 DM inadequately controlled on metformin alone or who are already treated w/ combination of vildagliptin & metformin as separate tab. In combination w/ other antidiabetics including insulin when these do not provide adequate glycaemic control.
Max vildagliptin dose: 100 mg daily. Inadequately controlled on metformin monotherapy or dual combination therapy w/ insulin Initially vildagliptin 50 mg bd + current metformin dose. Switching from co-administration of vildagliptin & metformin as separate tab Initiate based on current vildagliptin & metformin dose. Inadequately controlled on dual combination therapy w/ metformin & sulphonylurea Vildagliptin 50 mg bd & current metformin dose. Treatment-naive patient Initially 50 mg/500 mg once daily & gradually titrated to max dose: 50 mg/1,000 mg bd.
Discontinue use if jaundice or other signs of liver dysfunction develop. Temporarily discontinue use if dehydration occurs. Not to be used in type 1 diabetes. Risk of lactic acidosis; skin lesions including blistering & ulceration; acute pancreatitis; hypoglycaemia. Severe & disabling arthralgia in patients taking DPP-4 inhibitors. Assess renal function prior to initiation & regularly thereafter. Monitor liver function during treatment at 3 mth interval & periodically thereafter. Discontinue use prior to, during & 48 hr after iodinated contrast agent administration; surgery. May affect ability to drive & use machines. Not to be used in hepatic impairment including those w/ pre-treatment ALT or AST >3x ULN. Renal impairment (CrCl between 30 & 90 mL/min). Not to be used during pregnancy & lactation. Not recommended in childn <18 yr. Elderly.
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