As an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin phosephate and metformin HCI.

Recommended: Take KIASITA M 500 orally twice daily with meals.

• Assess renal function prior to initiation and periodically thereafter.
• KIASITA M is contraindicated in patients with an estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m2.
• KIASITA M is not recommended in patients with an eGFR between 30 and less than 45 mL/min/1.73 m2 because these patients require a lower dosage of sitagliptin.

There have been postmarketing reports of worsening renal function, including acute renal failure, sometimes requiring dialysis. Before initiation of therapy with KIASITA M and at least annually thereafter, renal function should be assessed. In patients in whom development of renal dysfunction is anticipated, particularly in elderly patients, renal function should be assessed more frequently and KIASITA M discontinued if evidence of renal impairment is present. KIASITA M is contraindicated in patients with severe renal impairment.

Sitagliptin Phosphate and Metformin Hydrochloride should not be used in patients with type 1 diabetes and must not be used for the treatment of diabetic ketoacidosis. Use of DPP-4 inhibitors has been associated with a risk of developing acute pancreatitis.