Adjunct to diet & exercise to improve glycemic control in patients w/ type 2 DM as monotherapy; or in dual combination w/ metformin, sulfonylurea or thiazolidinedione when diet, exercise & monotherapy do not result in adequate control; or in triple combination w/ sulfonylurea & metformin when diet & exercise plus dual therapy w/ these agents do not provide adequate glycemic control. In combination w/ insulin (w/ or w/o metformin) when diet, exercise & stable dose of insulin do not result in adequate glycemic control. Initial combination therapy w/ metformin in patients w/ type 2 DM whose diabetes is not adequately controlled by diet & exercise alone.
Individualized dosage Adult 50 mg once to bid. Max daily dose: 100 mg. Monotherapy & in combination w/ metformin/thiazolidinedione/insulin (w/ or w/o metformin) 50 or 100 mg daily. In dual combination w/ sulfonylurea 50 mg once daily. Triple combination w/ metformin & sulfonylurea 100 mg daily. Moderate to severe renal impairment or ESRD 50 mg once daily.
Not a substitute for insulin. Not for use in patients w/ type 1 diabetes & diabetic ketoacidosis. Perform LFT prior initiation & monitor during treatment at 3-mth intervals during the 1st yr & periodically thereafter. Monitor w/ a 2nd liver function evaluation in patients who develop increased transaminase levels. W/draw therapy if an increase in AST/ALT ≥3 x ULN persist. Discontinue in patients who develop jaundice or other signs suggestive of liver dysfunction. Heart failure (NYHA functional class IV). Not recommended in patients w/ hepatic impairment w/ pre-treatment ALT/AST >2.5 x ULN. Pregnancy & lactation. Childn <18 yr.
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