Dafgludin

Supplement to diet & exercise to help adults & childn ≥10 yr w/ type 2 DM achieve better glycemic control. Reduce chance of heart failure hospitalization in patients w/ type 2 DM who also have several CV risk factors or existing CV disease; risk for CV mortality & heart failure hospitalization in patients w/ heart failure (NYHA class II-IV) who have a lower ejection fraction; risk of end-stage kidney disease, CV death, hospitalization for heart failure, & prolonged reduction in estimated GFR in patients w/ CKD at risk of progression.

1 tab once daily. Max recommended daily dose of dapagliflozin 10 mg & metformin HCl 2,000 mg may be exceeded, however dose may be changed based on effectiveness & tolerability. Patient w/ heart failure & chronic renal disease Recommended dapagliflozin dose: 10 mg once daily. Patient ≥10 yr who is not currently taking dapagliflozin Starting dapagliflozin dose: 5 mg once daily.

Should be taken with food: Take in the morning. Do not chew/cut/crush. Swallow whole.

History of severe allergic reaction. Diabetic ketoacidosis & other forms of acute or chronic metabolic acidosis, w/ or w/o coma. ESRD, dialysis patients, or severe renal impairment (eGFR <30 mL/min/1.73 m²).

Use is not advised in patients w/ type 1 DM; polycystic kidney disease or those who need or have recently received immunosuppressive therapy for renal disease; eGFR <45 mL/min/1.73 m²; liver impairment. Discontinue treatment in patients w/ history of liver disease, alcoholism, or heart failure, & those who will receive intra-arterial iodinated contrast at time of or before an iodinated contrast imaging procedure; re-evaluate eGFR 48 hr following imaging procedure, & resume therapy if renal function is stable. Avoid treatment for at least 3 days before undergoing major surgery or extended fasting procedures; start treatment once patient is clinically stable & has resumed oral intake. Post-marketing cases of metformin-associated lactic acidosis, including fatal cases. Consider ketone monitoring in patients at risk for ketoacidosis. Assess for ketoacidosis regardless of presenting blood glucose levels & discontinue use if ketoacidosis is suspected; monitor for resolution of ketoacidosis before restarting therapy. Assess & correct vol status in elderly, patients w/ renal impairment or low systolic BP, & those on diuretics before initiating treatment; monitor for signs & symptoms of vol depletion during therapy. Evaluate for signs & symptoms of UTI & treat promptly, if indicated. Consider lower dose of concomitant insulin or insulin secretagogue. Institute prompt treatment if necrotizing fasciitis of the perineum (Fournier's gangrene) is suspected. May lower vit B₁₂ levels; measure hematological parameters annually. Monitor for genital mycotic infections & treat if indicated. May lead to +ve urine glucose tests & interference w/ 1,5-anhydroglucitol (1,5-AG) assay. Use is not advised during 2nd & 3rd trimesters of pregnancy & during nursing. Possibility of unwanted pregnancy in premenopausal women. Safety & efficacy in childn <10 yr have not been proven. Frequently evaluate renal function in the elderly.

Lactic acidosis, diabetic ketoacidosis (in patients w/ type 1 DM & other ketoacidoses), vol depletion, urosepsis & pyelonephritis, hypoglycemia in concomitant use w/ insulin & insulin secretagogues, necrotizing fasciitis of the perineum (Fournier's gangrene), lowered vit B₁₂ conc, genital mycotic infections.

Risk for lactic acidosis may be increased w/ topiramate or other carbonic anhydrase inhibitors (eg, zonisamide, acetazolamide or dichlorphenamide). Risk of hypoglycemia may be increased w/ insulin or insulin secretagogues (eg, sulfonylurea). Certain drugs including thiazides & other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, OCs, phenytoin, nicotinic acid, sympathomimetics, Ca channel blockers & INH tend to produce hyperglycemia & may lead to loss of glycemic control. May decrease serum lithium conc. Metformin HCl: Systemic exposure to metformin & risk for lactic acidosis may be increased w/ drugs that interfere w/ common renal tubular transport systems involved in the renal elimination of metformin eg, organic cationic transporter-2 (OCT2)/multidrug & toxin extrusion (MATE) inhibitors eg, ranolazine, vandetanib, dolutegravir, & cimetidine. Potentiated effect on lactate metabolism w/ alcohol.

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