Four Star
Concise Prescribing Info
Adjunct to diet & exercise in adults w/ insufficiently controlled type 2 DM given as monotherapy when metformin is considered inappropriate due to intolerance; in addition to other medicinal products for treatment of type 2 diabetes. Treatment of symptomatic chronic heart failure w/ reduced ejection fraction. Treatment of chronic kidney disease in adults.
Dosage/Direction for Use
10 mg once daily. Patient w/ severe hepatic impairment Initially 5 mg, may be increased to 10 mg if well tolerated.
May be taken with or without food.
Special Precautions
Patients at risk for vol depletion &/or hypotension. Carefully monitor vol status & electrolytes in cases of intercurrent conditions leading to vol depletion (eg, GI illness); temporary interruption of treatment for patients who develop vol depletion is recommended until depletion is corrected. Reports of acute kidney injury. Patients w/ increased risk of diabetic ketoacidosis (DKA). Discontinue immediately if DKA is suspected or diagnosed. Interrupt treatment in patients who are hospitalised for major surgical procedures or acute serious medical illness; monitoring of ketones is recommended in these patients. Should not be used in patients w/ type 1 diabetes. Discontinue use & prompt treatment should be instituted if Fournier's gangrene is suspected. Temporary interruption should be considered when treating pyelonephritis or urosepsis. Limited experience in NYHA class IV. No experience in treatment of CKD in patients w/o diabetes who do not have albuminuria. Increased cases of lower limb amputations in long-term, clinical studies in type 2 DM w/ another SGLT2 inhibitor. Counsel patients w/ DM on routine preventative foot care. Positive test for glucose in urine. Patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. Patients w/ severe hepatic impairment. Not recommended in patients w/ GFR <25 mL/min. Glucose lowering efficacy is reduced in patients w/ GFR <45 mL/min, & is likely absent in patients w/ severe renal impairment. Not recommended during 2nd & 3rd trimesters of pregnancy. Discontinue treatment once pregnancy is detected. Not to be used while breast-feeding. Elderly ≥65 yr. Childn <18 yr.
Adverse Reactions
Hypoglycaemia (when used w/ sulphonylurea or insulin). Vulvovaginitis, balanitis & related genital infections, UTI; dizziness; rash; back pain; dysuria, polyuria; increased haematocrit, decreased renal CrCl during initial treatment, dyslipidaemia.
Drug Interactions
Increased diuretic effect of thiazide & loop diuretics (increased risk of dehydration & hypotension). Hypoglycaemia w/ insulin & insulin secretagogues eg, sulphonylurea. Interference w/ 1,5-anhydroglucitol assay.
MIMS Class
Antidiabetic Agents / Other Cardiovascular Drugs
ATC Classification
A10BK01 - dapagliflozin ; Belongs to the class of sodium-glucose co-transporter 2 (SGLT2) inhibitors. Used in the treatment of diabetes.
Forxiga FC tab 10 mg
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