Not to be used in patients w/ type 1 diabetes or for treatment of diabetic ketoacidosis. Risk of lactic acidosis; decreased vit B12
serum levels; hypoglycemia. Monitor renal function prior to initiation, at least once a yr w/ normal renal function, 2-4 times a yr w/ serum creatinine levels at the ULN, in elderly & regularly thereafter. Concomitant use of medications affecting renal function or metformin HCl disposition. Temporary discontinuation in patients undergoing radiologic studies involving intravascular administration of iodinated contrast agent; surgical procedure. Discontinue treatment in case of hypoxemia. Avoid excessive alcohol intake. Perform LFTs prior to initiation & during treatment at 3-mth interval for the 1st yr & periodically thereafter. W/draw therapy if an increase in AST or ALT ≥3 x the ULN persist. Should not be reinitiated following withdrawal of treatment & LFT normalization. Monitor for skin disorders. May be temporarily w/held in case of loss in glycemic control. Not to be used in patients w/ CrCl <60 mL/min. Not recommended in patients w/ hepatic impairment including w/ pre-treatment ALT or AST >2.5 x ULN. Not to be used during pregnancy & breast-feeding. Not recommended in childn & adolescents <18 yr. Elderly ≥75 yr.