Per 5 mg/500 mg FC tab Empagliflozin 5 mg, metformin HCl 500 mg. Per 12.5 mg/500 mg FC tab Empagliflozin 12.5 mg, metformin HCl 500 mg. Per 12.5 mg/850 mg FC tab Empagliflozin 12.5 mg, metformin HCl 850 mg. Per 12.5 mg/1,000 mg FC tab Empagliflozin 12.5 mg, metformin HCl 1,000 mg
Adjunct to diet & exercise to improve glycaemic control in adults w/ type 2 DM when treatment w/ both empagliflozin & metformin is appropriate; inadequately controlled w/ metformin or empagliflozin alone, or in combination w/ other glucose-lowering products including insulin; already treated w/ empagliflozin & metformin co-administered as separate tab. Reduction of CV death risks in adults w/ type 2 DM & established CV disease.
Dosage/Direction for Use
Adult 1 tab bd. Max: Empagliflozin 25 mg & metformin 2,000 mg daily. Treatment-naïve patient Initially 5 mg/500 mg bd. Max: Empagliflozin 25 mg & metformin 2,000 mg daily. Patient switching from separate tab of empagliflozin & metformin Same daily dose as current empagliflozin & metformin dose.Patient inadequately controlled on max tolerated metformin dose alone or in combination w/ other product including insulin Initially empagliflozin 5 mg bd & metformin dose similar to the dose already being taken. May be increased to total daily dose of empagliflozin 25 mg if additional glycaemic control is needed. Renal impairment eGFR 60-89 mL/min Max: Metformin 3,000 mg & empagliflozin 25 mg daily, 45-59 mL/min Metformin: Initially at most ½ of max dose. Max: 2,000 mg daily. Empagliflozin: No dose adjustment, 30-44 mL/min Metformin: Initially at most ½ of max dose. Max: 1,000 mg daily. Empagliflozin: Not recommended.
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