Jardiance Duo

Per 12.5 mg/500 mg FC tab Empagliflozin 12.5 mg, metformin HCl 500 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 inadequately controlled w/ metformin alone or in combination w/ other glucose-lowering products including insulin or already treated w/ empagliflozin & metformin co-administered as separate tab. Adults w/ type 2 DM & established CV disease to reduce incidence of CV death.

Adult w/ normal renal function (GFR ≥90 mL/min) Recommended dose: 1 tab bd. Max daily dose: Empagliflozin 25 mg & metformin 2,000 mg. Patient not adequately controlled on metformin bd alone or in combination w/ other products 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. Patient switching from separate tab of empagliflozin  (10 or 25 mg total daily dose) & metformin (dose taken bd) Same daily dose as current empagliflozin & metformin dose. Renal impairment eGFR 60-89 mL/min Max daily dose: Empagliflozin 25 mg & metformin 3,000 mg, 45-59 mL/min Empagliflozin: No dose adjustment. Metformin: Initially at most ½ of max dose. Max daily dose: 2,000 mg, 30-44 mL/min Empagliflozin: Not to be initiated. Metformin: Initially at most ½ of max dose. Max daily dose: 1,000 mg.

Should be taken with food.

Hypersensitivity. Acute metabolic acidosis (eg, lactic acidosis, diabetic ketoacidosis); diabetic pre-coma; acute conditions w/ potential to alter renal function (eg, dehydration, severe infection, shock, intravascular administration of iodinated contrast agents); acute or chronic disease which may cause tissue hypoxia (eg, decompensated heart & resp failure, recent MI, shock). Severe renal impairment (CrCl <30 mL/min or eGFR <30 mL/min/1.73 m²). Hepatic insufficiency, acute alcohol intoxication, alcoholism.

Not to be used in patients w/ type 1 diabetes. Monitor for & discontinue temporarily in clinical situations known to predispose to ketoacidosis. Risk of lactic acidosis. Temporarily interrupt treatment in patients w/ complicated UTIs. Patients for whom empagliflozin-induced drop in BP pose a risk eg, known CV disease, on antihypertensive therapy w/ history of hypotension or ≥75 yr. Assess GFR prior to treatment initiation & regularly thereafter. Monitor vol status & electrolytes in case of fluid loss. Concomitant use w/ medicinal products that impair renal function eg, antihypertensives, diuretics & NSAIDs. Discontinue treatment prior to, during or until at least 48 hr after administration of iodinated contrast media; during surgery. May influence ability to drive & use machines. Hepatic injury. Not recommended during pregnancy. Not to be used during lactation. Not recommended in childn <18 yr & elderly ≥85 yr.

Hypoglycaemia (in combination w/ insulin &/or sulphonylurea), UTI, genital tract infections & increased urination. Vag moniliasis, vulvovaginitis, balanitis, other genital infections; nausea, vomiting, diarrhoea, abdominal pain, loss of appetite; lactic acidosis, decreased vit B₁₂ absorption, ketoacidosis; LFT abnormalities, hepatitis; taste disturbance; pruritus, allergic reactions; vol depletion; increased urination, dysuria; thirst; decreased GFR, increased blood creatinine, haematocrit & serum lipids.

Empagliflozin: May add to the diuretic effect of thiazide & loop diuretics & may increase risk of dehydration & hypotension. May increase risk of hypoglycaemia w/ insulin & insulin secretagogues eg, sulphonylureas. Potential risk of decreased efficacy w/ UGT enzyme inducers. Metformin: Not recommended w/ alcohol or iodinated contrast agents due to increased risk of lactic acidosis. NSAIDs (including selective COX II inhibitors), ACE inhibitors, AIIAs & diuretics (especially loop diuretics) can adversely affect renal function which may increase risk of lactic acidosis. Efficacy may be reduced w/ coadministration of organic cation transporters (OCT) 1 inhibitors eg, verapamil. GI absorption & efficacy may be increased w/ OCT1 inducers eg, rifampicin. Renal elimination may be decreased w/ OCT2 inhibitors eg, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole. Efficacy & renal elimination may be altered w/ OCT1 & OCT2 inhibitors eg, crizotinib, olaparib.

Antidiabetic Agents

A10BD20 - metformin and empagliflozin ; Belongs to the class of combinations of oral blood glucose lowering drugs. Used in the treatment of diabetes.

POM