Xigduo XR

Per 5 mg/500 mg XR-FC tab Dapagliflozin propanediol 5 mg, metformin HCl extended-release 500 mg. Per 5 mg/1,000 mg XR-FC tab Dapagliflozin propanediol 5 mg, metformin HCl extended-release 1,000 mg. Per 10 mg/1,000 mg XR-FC tab Dapagliflozin propanediol 10 mg, metformin HCl extended-release 1,000 mg

Adjunct to diet & exercise to improve glycemic control in adults w/ type 2 DM when treatment w/ both dapagliflozin & metformin is appropriate.

Individualized dosage. Recommended dose: 10 mg dapagliflozin once daily. Starting dose: 500 mg metformin once daily which can be titrated to 2,000 mg once daily w/ gradual dose escalation. Max dose: 10 mg dapagliflozin/2,000 mg metformin extended-release as two 5 mg/1,000 mg tab once daily. Patient at risk for vol depletion Starting dose: 5 mg dapagliflozin.

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

Hypersensitivity. Diabetic ketoacidosis, diabetic pre-coma. Acute conditions w/ 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. Acute alcohol intoxication, alcoholism. Severe renal (eGFR <30 mL/min/1.73 m²) & hepatic impairment. Lactation.

Not indicated for type 1 diabetes. Not to be used for diabetic ketoacidosis. Risk of lactic acidosis. Concomitant use w/ drugs that can acutely impair renal function (eg, antihypertensives, diuretics & NSAIDs). Discontinue treatment if lactic acidosis is suspected. Assess renal function prior to treatment initiation & periodically thereafter at least annually & at least 2-4 times yrly in patients w/ renal function where eGFR levels are approaching 45 mL/min/1.73 m² & elderly. Avoid in patients w/ clinical or lab evidence of hepatic disease. Discontinue use if acute conditions associated w/ hypoxia or impacting renal function (eg, dehydration, severe infections & hypoperfusion) occurs. Temporarily discontinue use prior to, or at the time of intravascular administration of iodinated contrast agents & do not reinstitute until 48 hr afterwards, & only after renal function has been re-evaluated & found to be stable. Discontinue use 48 hr before elective surgery under general, spinal or peridural anaesth. Excessive alcohol intake. Assess patients presenting w/ signs & symptoms consistent w/ ketoacidosis including nausea, vomiting, abdominal pain, malaise & shortness of breath; consider temporary interruption or discontinuation of treatment if ketoacidosis is suspected. 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 & alcohol abuse). Interrupt treatment in patients who are hospitalized for major surgical procedures or acute serious medical illnesses. Promptly evaluate patients w/ type 2 DM who develop lab abnormalities or clinical illness for evidence of ketoacidosis or lactic acidosis. Immediately discontinue treatment & initiate appropriate corrective measures if acidosis occurs. May reduce vit B₁₂ serum levels; periodically monitor in patients w/ risk factors for vit B₁₂ deficiency. Consider temporary interruption of treatment in patients who develop vol depletion. Concomitant use w/ drugs known to cause hypoglycemia eg, insulin or insulin secretagogues, other glucose-lowering agents (eg, sulfonylureas) or ethanol. Debilitated or malnourished patients & those w/ adrenal or pituitary insufficiency or alcohol intoxication. Patients taking β-adrenergic blockers. Discontinue use & institute prompt treatment if Fournier's gangrene is suspected. Not recommended in patients w/ eGFR persistently <45 mL/min/1.73 m². ESRD. Pregnancy (2nd & 3rd trimester). Discontinue use & consider alternative therapies when pregnancy is detected. Childn & adolescent. Elderly.

Renal impairment, increased blood creatinine, decreased renal CrCl & UTI. Dapagliflozin: Vulvovag mycotic infection. Genital infection; back pain; pollakiuria & polyuria. Metformin: GI symptoms (eg, nausea, vomiting, diarrhea, abdominal pain & appetite loss). Vit B₁₂ decrease/deficiency; taste disturbance.

Dapagliflozin: Concomitant use w/ lithium may lead to reduced serum lithium conc. Metformin: Potential interaction w/ cationic drugs (eg, amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim or vancomycin). Plasma & whole blood conc may be increased w/ oral cimetidine. Decreased AUC & C_max of glyburide. Plasma, blood C_max & AUC may be increased w/ furosemide. Enhanced absorption by 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. May interfere 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.

POM