Xigduo XR

Adjunct to diet & exercise in the treatment of type 2 DM in adults. Prevention of new or worsening heart failure, CV death, or nephropathy in adults.

Administer once daily. Dapagliflozin: 10 mg once daily. Metformin: Initially, 500 mg once daily, which can be titrated to 2,000 mg once daily w/ gradual dose escalation. Patient w/ renal impairment (eGFR 30-44 mL/min/1.73 m²) Max recommended dose: 10 mg/1,000 mg once daily.

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

Hypersensitivity. Metabolic acidosis. Severe renal impairment (eGFR <30 mL/min/1.73 m²).

Not indicated for the treatment of patients w/ type 1 DM. Risk of lactic acidosis, especially in patients w/ renal impairment. Discontinue treatment if lactic acidosis is suspected; in case of CV collapse (shock), acute CHF & MI, or other conditions characterized by hypoxemia; acute conditions eg, dehydration, severe infections, & hypoperfusion. Temporarily discontinue therapy prior to or at time of radiologic studies w/ intravascular iodinated contrast materials, & do not reinstitute until 48 hr afterwards & only reinstitute after renal function has been re-evaluated & found to be stable. Temporarily suspend use for any surgical procedure (except minor procedures not associated w/ restricted intake of food & fluids) & should not be restarted until patient's oral intake has resumed & renal function has been evaluated as stable. Warn patients against excessive alcohol intake during treatment. Consider discontinuation or temporary interruption if ketoacidosis is suspected. Discontinue treatment if Fournier's gangrene is suspected. Patient w/ type 2 diabetes previously well-controlled on Xigduo XR who develops lab abnormalities or clinical illness (especially vague & poorly defined illness) should be evaluated promptly for evidence of ketoacidosis or lactic acidosis; if acidosis of either form occurs, immediately stop treatment & initiate other appropriate corrective measures. Metformin may reduce vit B₁₂ serum levels. Periodic vit B₁₂ monitoring could be necessary in patients w/ risk factors for vit B₁₂ deficiency. Risk of hypoglycemia in elderly, debilitated, or malnourished patients & those w/ adrenal or pituitary insufficiency or alcohol intoxication. Lower dose of insulin or insulin secretagogue may be required to reduce risk of hypoglycemia when used in combination w/ dapagliflozin. Reduced glucose-lowering efficacy of dapagliflozin in patients w/ eGFR <45 mL/min/1.73 m². Not recommended to initiate treatment in patients w/ eGFR <45 mL/min/1.73 m². Assess renal function prior to initiation of therapy & then periodically thereafter at least annually; 2-4 times a yr in patients w/ renal function where eGFR levels are approaching 45 mL/min/1.73 m² & in elderly. Avoid in patients w/ clinical or lab evidence of hepatic disease. Must not be used in 2nd & 3rd trimesters of pregnancy. Discontinue treatment when pregnancy is detected. Must not be used by a nursing woman. Safety & effectiveness have not been established in ped & adolescent patients. Caution in the elderly.

Dapagliflozin: Genital infection, UTI; back pain, pollakiuria & polyuria. Metformin: GI symptoms. Vit B₁₂ decrease/deficiency; taste disturbance.

Dapagliflozin: May reduce serum conc of lithium. Monitoring glycemic control w/ 1,5-AG assay is not recommended. Metformin: Increased peak plasma & whole blood conc & plasma & whole blood AUC w/ oral cimetidine. Potential interaction w/ cationic drugs (eg, amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, or vancomycin) that are eliminated by renal tubular secretion. Decreased AUC & C_max of glyburide. Increased plasma & blood C_max & AUC w/ furosemide. Decreased C_max, AUC & terminal half-life of furosemide. Increased plasma C_max & AUC w/ nifedipine. May lead to loss of glycemic control w/ drugs producing hyperglycemia eg, thiazides & other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, OCs, phenytoin, nicotinic acid, sympathomimetics, Ca channel blocking drugs & 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.

Rx