Dapagliflozin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
Dapagliflozin is a highly potent, selective, and reversible inhibitor of sodium-glucose cotransporter 2 (SGLT2) that improves glycemic control in patients with type 2 diabetes mellitus by reducing renal glucose reabsorption leading to urinary excretion of excess glucose (glucuresis).
Dosage & Administration
5 mg orally once a day. May increase to 10 mg orally once a day in patients tolerating therapy with 5 mg and requiring additional glycemic control
Hypoglycemia may occur with concomitant use with insulin & insulin secretagogues eg sulfonylureas. Decrease in Cmax & AUC with rifampin. Increase in Cmax & AUC with mefenamic acid. Increased thiazide & loop diuretic effects; may increase risk of dehydration & hypotension. Pioglitazone.
Hypersensitivity to dapagliflozin propanediol or to any of the excipients. Moderate to severe renal impairment; end-stage renal disease; active bladder cancer. Pregnancy (2nd & 3rd trimester) & lactation.
Renal impairment, Female genital mycotic infections, Urinary tract infection, Increased urination, Male genital mycotic infections, Dyslipidemia, Constipation, Discomfort with urination, Extremity pain, Volume depletion, Hypersensitivity
Pregnancy & Lactation
Pregnancy Category-C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks
Precautions & Warnings
CV disease, history of hypotension, UTI, Children, Elderly. Unknown whether distributed in human breast milk; breastfeeding women should discontinue dapagliflozin or nursing taking into account the importance of the drug to the mother
Use in Special Populations
Renal Impairment: No dosage adjustment is indicated based on renal function. The efficacy is dependent on renal function. lt is not recommended for use in patients with moderate to severe renal impairment (patients with CrCI <60 mL/min or eGFR <60 mL/min/1.73 m2).
Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors