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. Symptomatic chronic heart failure w/ reduced ejection fraction in adults.
Dosage/Direction for Use
Type 2 DM 10 mg once daily. Heart failure 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. Reports of acute kidney injury. Patients w/ increased risk of diabetic ketoacidosis. Interrupt treatment in patients who are hospitalised for major surgical procedures or acute serious medical illnesses. Discontinue immediately if diabetic ketoacidosis is suspected or diagnosed. Should not be used in patients w/ type 1 diabetes. Discontinue use if Fournier's gangrene is suspected. Temporary interruption should be considered when treating pyelonephritis or urosepsis. Limited experience in NYHA class IV. Increased cases of lower limb amputations in long-term, clinical studies in type 2 DM w/ another SGLT2 inhibitor. Positive test for glucose in urine. Rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Patients w/ severe hepatic impairment. Not recommended during 2nd & 3rd trimesters of pregnancy. Not to be used during lactation. Elderly ≥65 yr. Childn <18 yr. Treatment of DM: Should not be initiated in patients w/ GFR <60 mL/min. Discontinue in patients w/ GFR persistently <45 mL/min. Treatment of heart failure: Patients w/ severe renal impairment (GFR <30 mL/min).
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.
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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