Glyhart

Monotherapy or in combination w/ other antidiabetics [eg, metformin &/or sulfonylurea, thiazolidinedione, dipeptidyl peptidase-4 inhibitor &/or insulin or glucagon-like peptide 1 receptor agonist (PR exenatide)] in patients w/ type 2 DM as an adjunct to diet & exercise. Patients w/ type 2 DM & established CV disease or multiple CV risk factors to reduce risk of hospitalization for heart failure. Heart failure in patients w/ reduced ejection fraction.

Type 2 DM (to improve glycemic control & reduce risk of hospitalization for heart failure) & heart failure Adult 10 mg once daily. When used as initial combination therapy to improve glycemic control in type 2 DM, recommended starting doses are dapagliflozin 10 mg & metformin 500 mg once daily. Severe hepatic impairment Initially 5 mg once daily, may be increased to 10 mg if well tolerated. Patient at risk for vol depletion Starting dose of 5 mg may be appropriate.

May be taken with or without food.

Hypersensitivity. Patients w/ eGFR <30 mL/min/1.73 m², ESRD or patients on dialysis.

Discontinue use if diabetic ketoacidosis is suspected or diagnosed; acute kidney injury occurs; necrotizing fasciitis of the perineum (Fournier's gangrene) is suspected. Not to be initiated to improve glycemic control in patients w/ eGFR persistently <60 mL/min/1.73 m² & should be discontinued at eGFR persistently <45 mL/min/1.73 m². Not to be used for diabetic ketoacidosis or in patients w/ history of diabetic ketoacidosis. Not indicated & should not be used in patients w/ type 1 diabetes. May cause intravascular vol depletion & renal impairment. May increase risk for genital mycotic infections in males (eg, balanitis) & females (eg, vulvovag mycotic infection); UTI. Patients w/ factors predisposing them to ketoacidosis including insulin deficiency from any cause (including insulin pump failure, history of pancreatitis or pancreatic surgery), insulin dose reduction, reduced caloric intake or increased insulin requirements due to infections, low carbohydrate diet, acute illness, surgery, previous ketoacidosis, dehydration & alcohol abuse. Consider temporarily discontinuing use for at least 3 days prior to surgery. Assess & correct vol status prior to initiation of therapy. Monitor for signs & symptoms of hypotension & renal function after initiating therapy. Evaluate renal function prior to initiation of treatment & periodically thereafter. Regularly examine feet & advise all patients w/ diabetes on routine preventative foot care. Not to be taken by patients w/ galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. May increase risk of hypoglycemia in combination w/ insulin or insulin secretagogue. +ve urine glucose tests. Monitoring glycemic control w/ 1,5-anhydroglucitol (1,5-AG) assay is not recommended as measurements of 1,5-AG in patients taking treatment. Caution in driving vehicle or operating machinery under conditions where risk of hypoglycemia is present. Not recommended during 2nd & 3rd trimesters of pregnancy & lactation. Not recommended in childn <18 yr. Elderly.

Female genital mycotic infections, nasopharyngitis, & UTI.

May potentially result in hypoglycemia w/ insulin & insulin secretagogues. Increased AUC & C_max of bumetanide. Increased AUC of glimepiride; simvastatin; valsartan. Increased C_max & AUC w/ mefenamic acid. Decreased C_max of pioglitazone. Decreased C_max & AUC w/ rifampicin.

Antidiabetic Agents

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

Rx