Patients w/ type 2 DM to improve glycemic control in combination w/ metformin, pioglitazone, sitagliptin (w/ or w/o metformin), gliclazide, glimepiride or glyburide (w/ or w/o metformin) or insulin (alone or w/ up to 2 antidiabetic medication) when the existing therapy, along w/ diet & exercise does not provide adequate glycemic control. Symptomatic chronic stable heart failure (NYHA functional class (II-III)) w/ reduced ejection fraction (left ventricular ejection fraction (LVEF) <40%), as an adjunct to standard of care therapy. CKD (eGFR 30-75 mL/min/1.73 m2) in reducing the risk of composite of ≥50% sustained eGFR decline, ESRD & renal or CV death.
Type 2 DM 10 mg once daily for add-on combination therapy w/ metformin, pioglitazone, sitagliptin (w/ or w/o metformin), gliclazide, glimepiride or glyburide (w/ or w/o metformin) or insulin (alone or w/ up to 2 antidiabetic medications). Combination w/ insulin secretagogue Lower dose of insulin secretagogue may be considered. Heart failure & CKD Recommended dose: 10 mg once daily. Severe hepatic impairment Initially 5 mg, may be increased to 10 mg if well tolerated.
Not to be used in type 1 DM or treatment of diabetic ketoacidosis. Consider temporary interruption of treatment when treating pyelonephritis or urosepsis; who develop vol depletion until the depletion is corrected. Monitor renal function prior to initiation of therapy & at least yrly thereafter; prior to initiation of concomitant medicinal products that may reduce renal function & periodically thereafter; w/ GFR <60 mL/min for at least 2-4 times yrly; vol status & electrolytes. Should not be initiated in patients w/ a GFR <60 mL/min & should be discontinued at GFR persistently <45 mL/min. Severe renal impairment (GFR <30 mL/min) or ESRD. CKD in patients w/o diabetes who do not have albuminuria. Not recommended in the treatment of heart failure in patients w/ type 1 DM. Heart failure in patients w/ severe renal impairment (GFR <30 mL/min). Assess patients who present w/ signs & symptoms consistent w/ ketoacidosis eg, nausea, vomiting, abdominal pain, malaise & shortness of breath. If ketoacidosis is suspected, discontinuation or temporary interruption of Forxiga should be considered & the patient should be promptly evaluated. Patients w/ predisposing factors to ketoacidosis; on anti-hypertensive therapy w/ history of hypotension; NYHA class IV; w/ already elevated haematocrit. In combination w/ glucagon-like peptide 1 (GLP-1) analogues. +ve test result for glucose in the urine. Rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption. Risk of hypoglycaemia when used in combination w/ sulphonylurea. Hepatic impairment. Not recommended during the 2nd & 3rd trimester of pregnancy; discontinue use if pregnancy is detected. Not to be used while breastfeeding. Childn <18 yr. Elderly.
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