COMPOSITION:
Each film-coated tablet contains
Linagliptin…………………. 5 mg
Metformin Hcl…………….. 500 mg
DESCRIPTION:
Linagliptin is a potent, reversible, and selective inhibitor of the enzyme DPP-4 (Dipeptidyl peptidase-4) which is involved in the inactivation of the incretin hormones- glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). These incretin hormones are rapidly degraded by the enzyme DPP-4. GLP-1 and GIP increase insulin biosynthesis and secretion from pancreatic beta cells in the presence of normal and elevated blood glucose levels. Furthermore, GLP-1 also reduces glucagon secretion from pancreatic alpha cells, resulting in a reduction in hepatic glucose production. Linagliptin binds to DPP-4 enzyme in a reversible manner and thus leads to an increase and a prolongation of active incretin levels. Linagliptin glucose-dependently increases insulin secretion and lowers glucagon secretion thus resulting in an overall improvement in glucose homeostasis.
Metformin is an antihyperglycemic agent that improves glucose tolerance in patients with type 2 diabetes, lowering both basal and postprandial plasma glucose. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization. Unlike sulfonylureas, metformin does not produce significant hypoglycemia in either patients with type 2 diabetes or normal subjects and does not cause hyperinsulinemia.
INDICATIONS & USAGE:
Linapaz M is a dipeptidyl peptidase-4 (DPP-4) inhibitor and biguanide combination product indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both linagliptin and metformin is appropriate.
DOSAGE & ADMINISTRATION:
As directed by the physician.
CONTRA-INDICATIONS:
Any patient with a known hypersensitivity to linagliptin or any of the components in the formulation, Severe ketosis, diabetic coma or history of diabetic coma, type 1 diabetic patients, patients with severe infection, surgery, severe trauma (blood sugar control should preferably be done by insulin).
Severe renal impairment (eGFR below 30 mL/min/1.73 m2), known hypersensitivity to metformin hydrochloride, acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin.