Zemidapa

As an adjunct to diet & exercise to improve glycemic control in adults w/ type 2 DM.

Adult 1 tab once daily.

May be taken with or without food.

Hypersensitivity to gemigliptin or dapagliflozin, or history of serious hypersensitivity reactions eg, angioedema or anaphylaxis to dipeptidyl peptidase-4 (DDP-4) inhibitor or Na glucose cotransporter 2 (SGLT2) inhibitor. Type 1 diabetes or diabetic ketoacidosis (DKA). Rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Hemodialysis.

Reports of pancreatitis, severe & disabling arthralgia, & bullous pemphigoid requiring hospitalization, in patients taking other DPP-4 inhibitors. Discontinue treatment if a severe hypersensitivity reaction is suspected. Increased risk of genital mycotic infections w/ dapagliflozin. Increased cases of lower limb amputation (primarily of the toe) in long-term clinical studies in type 2 DM w/ SGLT2 inhibitors; counsel patients on routine preventative foot care. Reports of Fournier's gangrene in patients taking SGLT2 inhibitors. Immediately discontinue if DKA is suspected or diagnosed. Interrupt treatment in patients who are hospitalized for major surgical procedures or acute serious medical illnesses; monitor ketones in these patients & restart treatment when ketone values are normal & patient's condition has stabilized. Not recommended to restart SGLT2 inhibitor treatment in patients w/ previous DKA while on SGLT2 inhibitor treatment, unless another clear precipitating factor is identified & resolved. Caution in patients at risk for vol depletion &/or hypotension; patients w/ NYHA class I, II cardiac status; patients w/ severe hepatic impairment; elderly ≥70 yr. Avoid in patients w/ NYHA class III, IV cardiac status. Evaluate renal function prior to treatment initiation & periodically thereafter. Not recommended in patients w/ eGFR <45 mL/min/1.73 m². Should not be used during pregnancy & lactation.

Increased lipase, chronic gastritis, dizziness, UTI, cough, diabetic nephropathy, gastritis, gingivitis, large intestine polyp, urticaria, dyspepsia.

Gemigliptin: Decreased exposure w/ strong CYP3A4 inducers eg, rifampicin (rifampin), dexamethasone, phenytoin, carbamazepine, rifabutin & phenobarb. Dapagliflozin: May add to the diuretic effect of thiazide & loop diuretics & may increase risk of dehydration & hypotension. Increased risk of hypoglycemia w/ insulin & insulin secretagogues eg, sulfonylureas. Decreased systemic exposure w/ rifampicin. Increased systemic exposure w/ mefenamic acid. Interference w/ 1,5-anhydroglucitol assay.

Antidiabetic Agents

A10BD30 - gemigliptin and dapagliflozin ; Belongs to the class of combinations of oral blood glucose lowering drugs. Used in the treatment of diabetes.

Rx