Dapazin

Adjunct to diet & exercise to improve glycemic control in adults w/ type 2 DM.

Type 2 DM (to improve glycemic control) Initially 5 mg once daily, may be increased to 10 mg once daily in patients tolerating dapagliflozin 5 mg once daily who require additional glycemic control.

May be taken with or without food: Take in the morning.

History of serious hypersensitivity reaction eg, anaphylactic reactions or angioedema. Patients who are being treated for glycemic control w/o established CV disease or multiple CV risk factors w/ severe renal impairment (eGFR <30 mL/min/1.73 m²); on dialysis or w/ ESRD.

Not recommended for patients w/ type 1 DM or for the treatment of diabetic ketoacidosis; patients w/ eGFR 30-<45 mL/min/1.73 m². Vol depletion; patients w/ impaired renal function (eGFR <60 mL/min/1.73 m²), elderly, or patients on loop diuretics may be at increased risk for vol depletion or hypotension. Assess vol status & renal function before initiating therapy in patients w/ ≥1 of these characteristics. Monitor for signs & symptoms of hypotension, & renal function after initiating therapy. Ketoacidosis in patients w/ DM. Assess patients on treatment who present w/ signs & symptoms consistent w/ severe metabolic acidosis for ketoacidosis regardless of presenting blood glucose levels. Discontinue use, evaluate patient & institute prompt treatment if ketoacidosis is suspected. Consider factors in patient history that may predispose to ketoacidosis, including pancreatic insulin deficiency from any cause, caloric restriction, & alcohol abuse before initiating treatment; temporarily discontinuing treatment for at least 3 days prior to surgery for patients who undergo scheduled surgery; monitoring for ketoacidosis & temporarily discontinuing treatment in other clinical situations known to predispose to ketoacidosis (eg, prolonged fasting due to acute illness or post-surgery). Ensure risk factors for ketoacidosis are resolved prior to restarting treatment. Educate patients on signs & symptoms of ketoacidosis & instruct patients to discontinue use if signs & symptoms occur. Serious UTI including urosepsis & pyelonephritis requiring hospitalization. Increased risk for UTI w/ SGLT2 inhibitors treatment. Evaluate patients for signs & symptoms of UTI & treat promptly, if indicated. Hypoglycemia in concomitant use w/ insulin & insulin secretagogues. Reports of necrotizing fasciitis of the perineum (Fournier's gangrene) in patients w/ DM receiving SGLT2 inhibitors, including dapagliflozin. Assess patients on treatment presenting w/ pain or tenderness, erythema, or swelling in the genital or perineal area, along w/ fever or malaise for necrotizing fasciitis; start treatment immediately w/ broad-spectrum antibiotics if suspected & surgical debridement if necessary; discontinue use, closely monitor blood glucose levels, & provide appropriate alternative therapy for glycemic control. Increased risk of genital mycotic infections; monitor patients w/ a history of genital mycotic infections & treat appropriately. Use alternative methods to monitor glycemic control as treatment will lead to +ve urine glucose tests & interference w/ 1, 5-anhydroglucitol (1, 5-ag) assay. Not recommended during the 2nd & 3rd trimesters of pregnancy & during lactation.

Severe hypoglycemia & diabetic ketoacidosis. Female/male genital mycotic infections, nasopharyngitis, UTI, back pain, increased urination, nausea, flu, dyslipidemia, constipation, discomfort w/ urination, pain in extremity.

Increased risk of hypoglycemia when combined w/ insulin or insulin secretagogue.

Antidiabetic Agents

A10BK01 - dapagliflozin ; Belongs to the class of sodium-glucose co-transporter 2 (SGLT2) inhibitors. Used in the treatment of diabetes.

Rx