Adjunct to diet & exercise to improve glycaemic control in type 2 DM. As monotherapy or in dual combination w/ metformin, sulfonylurea (SU) or thiazolidinedione (TZD) when diet, exercise & monotherapy do not result in adequate glycaemic control. In triple combination in patients w/ uncontrolled use of sulfonylurea (SU) & metformin when diet, exercise & dual therapy do not provide adequate glycaemic control. In combination w/ insulin when maximal tolerated dose of insulin as an adjunct to diet & exercise do not provide adequate glycemic control. It is not recommended as initial therapy.
Individualized dosage. Monotherapy 50 mg once daily in the morning or 100 mg in 2 divided doses in the morning & in the evening. Dual combination therapy 50 mg once daily in the morning or 100 mg in 2 divided doses in the morning & in the evening in combination w/ metformin, TZD or insulin. Triple combination therapy 50 mg twice daily w/ metformin & SU. Patient w/ mderate or severe renal impairment 50 mg once daily.
Not to be used in patients w/ type 1 diabetes or for treatment of diabetic ketoacidosis. W/draw therapy if an increase in AST/ALT ≥3 x the ULN persist. Should not be reinitiated following withdrawal of treatment & LFT normalization. Perform LFTs prior to initiation & during treatment at 3-mth interval for the 1st yr & periodically thereafter. Contains lactose. Not recommended in patients w/ NYHA class IV; ESRD on haemodialysis; hepatic impairment including patients w/ pre-treatment ALT or AST >2.5 x the ULN. Not to be used during pregnancy & breast-feeding. Not recommended in patients <18 yr.