Zemidapa

Adjunct to diet & exercise to improve glycemic control in adults w/ type 2 DM when metformin & one of the monocomponents do not provide adequate glycaemic control; when already being treated w/ free combination of dapagliflozin & gemigliptin.

Adult 1 tab once daily.

May be taken with or without food.

Hypersensitivity or history of serious hypersensitivity reactions ie, angioedema or anaphylaxis to another dipeptidyl peptidase-4 (DPP-4) inhibitor or Na glucose cotransporter (SGLT) 2 inhibitor. Type 1 diabetes or diabetic ketoacidosis. Galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Hemodialysis.

Discontinue use if serious hypersensitivity reaction occurs; pancreatitis, bullous pemphigoid, Fournier's gangrene are suspected; diabetic ketoacidosis is suspected or diagnosed. Not to be used in patients w/ type 1 diabetes. Avoid use in patients w/ NYHA class III, IV cardiac status. History of pancreatitis; severe & disabling arthralgia; genital mycotic infections. Patients w/ NYHA class I, II cardiac status; at risk for vol-depletion &/or hypotension; w/ low β-cell function reserve, conditions leading to restricted food intake or severe dehydration, reduced insulin doses, increased insulin requirements due to acute medical illness, surgery or alcohol abuse; UTI, urosepsis & pyelonephritis; underlying bladder disorders. Body wt loss; +ve glucose urine test. Monitor vol status eg, physical exam, BP, haematocrit & electrolytes. Evaluate renal function prior to initiation & periodically thereafter. Counsel patients on routine preventative foot care. Hypoglycemia w/ insulin & insulin secretagogues eg, sulfonylurea. Concomitant use w/ antihypertensives. May affect ability to drive & use machines. Not recommended in patients w/ estimated GFR <45 mL/min/1.73 m². Severe hepatic impairment. Not to be used during pregnancy & lactation. Childn & adolescents <18 yr. Elderly.

Increased lipase, ALT, AST & blood creatine phosphokinase, decreased wt; chronic & erosive gastritis, gastritis, large intestine polyp, dyspepsia, constipation, GERD, nausea, epigastric discomfort; UTI, gingivitis, COVID-19, cystitis, nasopharyngitis, URTI; dizziness, headache; insomnia; cough; diabetic nephropathy, haematuria, pollakiuria; urticaria, pruritus; hypoglycaemia; myalgia, back pain, pain in extremity, arthralgia; genital & vulvovag pruritus; chest pain; hepatic steatosis.

Gemigliptin: Decreased C_max of metformin. Decreased AUC & C_max of pioglitazone. Increased AUC w/ ketoconazole. Decreased AUC & C_max w/ rifampicin. Not recommended w/ other strong CYP3A4 inducers eg, dexamethasone, phenytoin, carbamazepine, rifabutin, phenobarb. Dapagliflozin: Added diuretic effect of thiazide & loop diuretics. Increased risk of hypoglycemia w/ insulin & insulin secretagogues eg, sulfonylureas. Reduced serum lithium conc. 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.

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