Lupizin

Insufficiently controlled type 2 DM as an adjunct to diet & exercise in adults as monotherapy when metformin is considered inappropriate due to intolerance or in addition to other medicinal products for treatment of type 2 diabetes. Symptomatic chronic heart failure w/ reduced ejection fraction in adults. CKD in adults.

Type 2 DM, heart failure, CKD 10 mg once daily. Patient w/ severe hepatic impairment Initially 5 mg, may be increased to 10 mg.

May be taken with or without food: Swallow whole.

Hypersensitivity.

Discontinue use when diabetic ketoacidosis or Fournier's gangrene is suspected or diagnosed. Interrupt treatment temporarily in patients who develop vol depletion until depletion is corrected; patients who are hospitalised for major surgical procedures or acute serious medical illnesses & monitor ketones accordingly. Not to be used in patients w/ type 1 diabetes. Increased risk of UTI. Increased cases of lower limb amputations. Patients for whom a dapagliflozin-induced drop in BP could pose a risk eg, patients on antihypertensive therapy w/ history of hypotension or elderly. Carefully monitor vol status (eg, physical exam, BP measurements, lab tests including hematocrit & electrolytes) in case of intercurrent conditions that may lead to vol depletion eg, GI illness. Consider factors in patient history that may predispose to ketoacidosis prior to initiating therapy. Counsel patients w/ diabetes on routine preventative foot care. Limited experience in NYHA class IV. No experience for CKD in patients w/o diabetes who do not have albuminuria. Has not been studied for CKD in patients w/ polycystic kidney disease, glomerulonephritis w/ flares (lupus nephritis or ANCA-associated vasculitis), ongoing or recent requirements of cytotoxic, immunosuppressive or other immunomodulating renal therapy, or in patients who received organ transplant. +ve test for glucose in urine. Not to be taken by patients w/ galactose intolerance, total lactase deficiency or glucose galactose malabsorption. Not recommended in patients w/ eGFR <15 mL/min/1.73 m². Limited experience in patients w/ eGFR <25 mL/min/1.73 m². Reduced glucose-lowering efficacy in patients w/ type 2 DM w/ eGFR <45 mL/min/1.73 m². Limited experience in hepatic impairment. Increased exposure in patients w/ severe hepatic impairment. Not recommended during 2nd & 3rd trimesters of pregnancy. Discontinue use when pregnancy is detected. Not to be used while breast-feeding. Safety & efficacy have not yet been established in childn <18 yr. Greater risk of vol depletion in elderly ≥65 yr.

Hypoglycaemia (when used w/ sulfonylurea or insulin). Vulvovaginitis, balanitis & related genital infections, UTI; dizziness; rash; back pain; dysuria, polyuria; increased haematocrit, decreased renal CrCl during initial treatment, dyslipidaemia.

May add to the diuretic effect of thiazide & loop diuretics & may increase risk of dehydration & hypotension. Risk of hypoglycaemia w/ insulin & insulin secretagogues eg, sulphonylureas. Interference w/ 1,5-anhydroglucitol assay.

Antidiabetic Agents

A10BK01 - dapagliflozin ; Belongs to the class of sodium-glucose co-transporter 2 (SGLT2) inhibitors. Used in the treatment of diabetes.

Rx