Treatment of adults w/ insufficiently controlled type 2 DM as an adjunct to diet & exercise, as monotherapy when metformin is considered inappropriate due to intolerance or contraindications; or in addition to other medicinal products for the treatment of diabetes.
Do not use in patients w/ type 1 DM or for treatment of diabetic ketoacidosis. Not a substitute for insulin. Potential risk of dehydration, particularly in relation to GI side effects; avoid fluid depletion. Not recommended in patients w/ severe GI disease eg, severe gastroparesis. Risk of acute pancreatitis. Increased risk of hypoglycaemia in combination w/ sulphonylurea or insulin. Avoid driving & using machines in the presence of hypoglycaemia. Not recommended in patients w/ end stage renal disease (<15 mL/min/1.73 m2). Not recommended during pregnancy. Should not be used during breast-feeding. Safety & efficacy in childn <18 yr have not been established.
May impact absorption rate of concomitantly administered oral medicinal products. May slightly alter drug exposure of some PR formulations. Increased exposure w/ sitagliptin leading to enhanced effects on blood glucose levels.
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