Xigduo XR

Per 5 mg/1,000 mg XR-FC tab Dapagliflozin 5 mg, metformin HCl extended-release 1,000 mg. Per 10 mg/1,000 mg XR-FC tab Dapagliflozin 10 mg, metformin HCl extended-release 1,000 mg

Adjunct to diet & exercise to improve glycemic control in adults w/ type 2 DM when appropriate. Prevention of new or worsening heart failure, CV death or nephropathy.

Recommended starting dose: Dapagliflozin 10 mg & metformin 500 mg once daily, may be titrated to 2,000 mg once daily. Patient at risk for vol depletion Initially Dapagliflozin 5 mg.

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

History of serious hypersensitivity. Metabolic acidosis. Severe renal impairment (estimated GFR <30 mL/min/1.73 m²).

Not to be used in patients w/ type 1 DM or diabetic ketoacidosis. Discontinue use prior to or during iodinated contrast administration & not to be reinstituted until 48 hr afterwards. Lactic acidosis; poorly controlled diabetes, ketosis, prolonged fasting, any conditions associated w/ hypoxia; CV collapse (shock), acute CHF & MI, other conditions associated w/ hypoxemia; acute conditions eg, dehydration, severe infections, hypoperfusion; risk of vol depletion, hypotension or electrolyte imbalance; patients w/ low β-cell function reserve; insulin dose reduction; reduced caloric intake; increased insulin requirements due to infection, illness, surgery or alcohol abuse; loss of blood glucose control. Assess renal function prior to & periodically thereafter. Evaluate serum electrolytes & ketones, blood glucose, pH, lactate, pyruvate & metformin levels. Hypoglycemia w/ insulin & insulin secretagogues eg, sulfonylureas. Concomitant use w/ antihypertensive, diuretics, NSAIDs; drugs causing lactic acidosis. Interference w/ 1,5-anhydroglucitol assay. Excessive alcohol intake. Not recommended in patients w/ estimated GFR persistently <45 mL/min/1.73 m². Severe renal impairment estimated GFR<30 mL/min/1.73 m² or ESRD. Clinical or lab evidence of hepatic impairment. Not to be used during 2nd & 3rd trimesters of pregnancy & lactation. Ped & adolescent patients. Elderly.

Dapagliflozin: Genital infection, UTI; back pain; pollakiuria & polyuria. Metformin: GI symptoms. Taste disturbance.

Dapagliflozin: Decreased exposure w/ rifampicin. Increased exposure w/ mefenamic acid. Metformin: Potential interaction in renal tubular secretion w/ cationic drugs eg, amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, vancomycin. Increased plasma C_max & AUC w/ furosemide, nifedipine. Hyperglycemia w/ thiazides, other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, OCs, phenytoin, nicotinic acid, sympathomimetics, Ca-channel blockers, INH.

Antidiabetic Agents

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

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