Xigduo XR

Per 5 mg/1,000 mg Dapagliflozin propanediol monohydrate 5 mg, metformin HCl 1,000 mg. Per 10 mg/1,000 mg Dapagliflozin propanediol monohydrate 10 mg, metformin HCl 1,000 mg

Adjunct to diet & exercise to improve glycaemic control in adult w/ type 2 DM when treatment w/ both dapagliflozin & metformin is appropriate. Reduce risk of hospitalization for heart failure in adult w/ type 2 DM & established CV disease or risk factors for CV disease.

Individualized dosage. Max: Dapagliflozin 10 mg & metformin XR 2,000 mg. Should be administered once daily.

Should be taken with food: Take w/ evening meal. Swallow whole, do not chew/crush/cut.

Hypersensitivity. Acute or chronic metabolic acidosis, including lactic acidosis or diabetic ketoacidosis, w/ or w/o coma; diabetic pre-coma; eGFR persistently <45 mL/min/1.73 m²; acute conditions w/ the potential to alter renal function eg, dehydration, severe infection, shock, or intravascular administration of iodinated contrast agents; acute or chronic disease which may cause tissue hypoxia eg, cardiac or resp failure, pulmonary embolism, recent MI, shock, acute significant blood loss, sepsis, gangrene, pancreatitis; during or immediately following surgery where insulin is essential, elective major surgery; hepatic impairment; acute alcohol intoxication, alcoholism. Lactation.

Should not be used in patients w/ type 1 DM or for the treatment of diabetic ketoacidosis. Risk of lactic acidosis & renal function abnormalities. Assess renal function prior to treatment initiation & periodically thereafter. Type 2 DM patient previously well controlled on Xigduo XR who develops laboratory abnormalities or clinical illness should be evaluated promptly for evidence of lactic acidosis. Avoid use in patients w/ clinical or laboratory evidence of hepatic disease. Discontinue treatment prior to, or at the time of radiologic study w/ intravascular iodinated contrast agent, & do not reinstitute until 48 hr afterwards & after renal function is stable. Discontinue treatment at least 48 hr prior to major surgery; do not restart until 48 hr following surgery once patient's condition is stable, oral intake is normal & renal function is normal. Caution in patients at risk for vol depletion &/or hypotension. No experience in clinical studies w/ dapagliflozin in NYHA class IV. Reports of UTI including urosepsis & pyelonephritis; Fournier's gangrene; increase in cases of lower limb amputation (primarily of the toe) w/ another SGLT2 inhibitor; acute kidney injury; ketoacidosis. Perform routine serum vit B₁₂ measurements at 2-3 yr intervals in patients predisposed to developing subnormal vit B₁₂ levels. Concomitant use w/ medications known to cause hypoglycaemia; excessive alcohol intake. Monitoring glycaemic control w/ 1,5-AG assay is not recommended. Effects on laboratory tests eg, increases from baseline in mean haematocrit values & serum P levels, small changes from baseline in mean lipid values. May impair ability to drive & use machines. Discontinue treatment when pregnancy is detected. Not to be used during lactation. Elderly.

Renal impairment, decreased CrCl, increased blood creatinine, UTI, vulvovaginal mycotic infection.

Metformin HCl: Potential interaction w/ cationic drugs that are eliminated by renal tubular secretion eg, amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, vancomycin. Pharmacokinetic parameters of both metformin & frusemide were affected when co-administered. Enhanced absorption w/ nifedipine. Thiazides & other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, OCs, phenytoin, nicotinic acid, sympathomimetics, Ca channel blocking drugs & INH may produce hyperglycaemia leading to loss of blood glucose control.

Antidiabetic Agents

A10BD15 - metformin and dapagliflozin ; Belongs to the class of combinations of oral blood glucose lowering drugs. Used in the treatment of diabetes.

P₁S₁S₃