Each film-coated extended-release tablet contains Empagliflozin 5 mg, 10 mg, 12.5 mg, or 25 mg in combination with Metformin Hydrochloride Extended Release 1000 mg.

Empagliflozin + Metformin Extended-Release Tablets combine two complementary antihyperglycemic agents in a convenient formulation for effective management of type 2 diabetes mellitus. Empagliflozin, an SGLT2 inhibitor, promotes urinary glucose excretion by reducing renal glucose reabsorption, while Metformin improves insulin sensitivity, suppresses hepatic glucose production, and decreases intestinal glucose absorption. The combination provides comprehensive glycemic control, supports weight neutrality, and offers the convenience of combination therapy to improve treatment adherence.

Empagliflozin + Metformin Extended-Release Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are inadequately controlled on Empagliflozin or Metformin alone, or who are already receiving both agents separately.

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 increases sodium delivery to the distal renal tubules, which may contribute to reductions in cardiac preload and afterload. Metformin is an antihyperglycemic agent that lowers both fasting and postprandial plasma glucose by decreasing hepatic glucose production, reducing intestinal glucose absorption, and improving peripheral insulin sensitivity and glucose utilization.

The maximum recommended daily dosage is Empagliflozin 25 mg and Metformin Hydrochloride 2000 mg. Tablets should be taken orally twice daily with meals, with gradual dose escalation to minimize gastrointestinal adverse effects associated with Metformin. Dosage should be individualized according to the patient's glycemic response, renal function, and previous therapy.

This combination is contraindicated in patients with severe renal impairment (eGFR below 30 mL/min/1.73 m²), end-stage renal disease, or those receiving dialysis. It is also contraindicated in patients with metabolic acidosis, including diabetic ketoacidosis, and in individuals with known hypersensitivity to Empagliflozin, Metformin, or any component of the formulation.