Xigduo XR

Substitution therapy for type II DM in adjunct to diet & exercise to improve glycemic control in adult patients already controlled w/ dapagliflozin & metformin XR given concurrently at the same dose level.

Once daily dosing. Max daily dose: Dapagliflozin 10 mg & metformin HCl 2,000 mg.

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

History of any serious hypersensitivity reaction. Acute or chronic metabolic acidosis, including diabetic ketoacidosis w/ or w/o coma. Diabetic pre-coma. Acute conditions w/ potential to alter renal function eg, dehydration, severe infection, shock. Acute or chronic disease causing tissue hypoxia eg, cardiac or resp failure, recent MI, acute alcohol intoxication, alcoholism. Severe renal impairment (eGFR <30 mL/min/1.73 m²), ESRD or patients on dialysis. Hepatic impairment.

Not indicated for type 1 DM. Not to be used for diabetic ketoacidosis. Lactic acidosis. Excessive alcohol intake. Patients w/ predisposing factors to ketoacidosis (eg, low β-cell function reserve from pancreatic disorders, insulin dose reduction, reduced caloric intake or increased insulin requirements due to infections, illness or surgery); loss of blood glucose control; risk for vol depletion, GI illness, heat stress, severe infections, known CV disease, history of hypotension, UTI, urosepsis, pyelonephritis; NYHA class IV. Assess for signs & symptoms consistent w/ ketoacidosis including nausea, vomiting, abdominal pain, malaise & shortness of breath. Discontinue use 48 hr before elective surgery under general, spinal or epidural anaesth. Temporarily discontinue in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials. Perform routine serum vit B₁₂ measurements at 2- to 3-yr intervals. Assess renal function prior to & periodically thereafter. Regularly evaluate serum electrolytes & ketones, blood glucose, pH, lactate, pyruvate & metformin levels. Acute or chronic excessive alcohol intake. Counsel patients on routine preventative foot care. May affect ability to drive & use machines. Concomitant use w/ antihypertensives, diuretics, NSAIDs; cationic drugs; drugs causing hypoglycemia eg, insulin & insulin secretagogues (eg, sulfonylureas). Not recommended in patients w/ eGFR <45 mL/min/1.73 m². Avoid use in patients w/ clinical or lab evidence of hepatic disease. Not be used in 2nd & 3rd trimesters of pregnancy & lactation. Childn & adolescent. Elderly.

Renal impairment, increased blood creatinine, decreased renal CrCl, UTI, genital infection, polyuria. Dapagliflozin: Vulvovag mycotic infection. Back pain. Metformin: Diarrhea, nausea/vomiting.

Dapagliflozin: Reduced serum lithium conc. Metformin: Potential competition in renal tubular secretion w/ cationic drugs eg, amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim or vancomycin. Increased plasma, blood C_max & AUC w/ furosemide, nifedipine. May lead to loss of glycemic control w/ thiazides & other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, OCs, phenytoin, nicotinic acid, sympathomimetics, Ca-channel blockers & INH. Interference w/ 1,5-anhydroglucitol assay.

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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