Each film-coated tablet contains Empagliflozin with Sitagliptin Phosphate Monohydrate equivalent to Sitagliptin and Metformin Hydrochloride Sustained Release in the following strengths: 10 mg + 100 mg + 500 mg, 10 mg + 100 mg + 1000 mg, 25 mg + 100 mg + 500 mg, and 25 mg + 100 mg + 1000 mg.

Empagliflozin + Sitagliptin + Metformin SR Tablets combine three complementary antihyperglycemic agents in a single formulation to provide comprehensive glycemic control in adults with type 2 diabetes mellitus. Empagliflozin promotes urinary glucose excretion by inhibiting SGLT2, Sitagliptin enhances incretin activity through DPP-4 inhibition to improve glucose-dependent insulin secretion, and Metformin reduces hepatic glucose production while improving insulin sensitivity. This triple combination helps improve fasting and postprandial blood glucose control while simplifying treatment with once-daily dosing.

Empagliflozin + Sitagliptin + Metformin SR Tablets are indicated for the treatment of adults with type 2 diabetes mellitus who remain inadequately controlled on metformin monotherapy. They are used as an adjunct to diet and exercise to improve glycemic control.

Empagliflozin selectively inhibits sodium-glucose co-transporter-2 (SGLT2), reducing renal glucose reabsorption, lowering the renal threshold for glucose, and increasing urinary glucose excretion. It also promotes sodium excretion, which may contribute to cardiovascular and renal benefits. Sitagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor that prolongs the activity of incretin hormones, thereby increasing glucose-dependent insulin secretion and reducing glucagon secretion. Metformin is an antihyperglycemic agent that decreases hepatic glucose production, reduces intestinal glucose absorption, and enhances peripheral insulin sensitivity, resulting in improved glycemic control.

The recommended starting dose of Empagliflozin is 10 mg once daily, which may be increased to 25 mg once daily in patients requiring additional glycemic control and tolerating therapy. Sitagliptin is administered at 100 mg once daily. The maximum recommended daily dose of Metformin is 2550 mg in adults and 2000 mg in pediatric patients aged 10–16 years. The combination tablet should be taken once daily with the morning meal and swallowed whole without crushing or chewing.

This combination is contraindicated in patients with severe renal impairment, end-stage renal disease, or those undergoing dialysis. It is also contraindicated in patients with metabolic acidosis, including diabetic ketoacidosis, and in individuals with known hypersensitivity to Empagliflozin, Sitagliptin, Metformin, or any component of the formulation.