Jardiance Duo

Adjunct to diet & exercise to improve glycaemic control in adults w/ type 2 DM when treatment w/ both empagliflozin & metformin is appropriate. Adjunct to diet & exercise to improve glycaemic control in childn ≥10 yr w/ type 2 DM when treatment w/ both empagliflozin & metformin is appropriate; inadequately controlled w/ metformin alone or in combination w/ insulin; already treated w/ empagliflozin & metformin co-administered as separate tab. Adults w/ type 2 DM & established CV disease to reduce the risk of CV death; should be used in conjunction w/ other measures to reduce CV risk in line w/ current standard of care.

Recommended dose: 1 tab bid. Adult w/ normal renal function (GFR ≥90 mL/min) Max daily dose: 25 mg for empagliflozin and 2,000 mg for metformin. Patient not adequately controlled on metformin alone or in combination w/ other products including insulin Empagliflozin 5 mg bid + metformin dose already being taken. Patient tolerating a total daily dose of empagliflozin 10 mg May be increased to empagliflozin 25 mg total daily dose. Patient already treated w/ empagliflozin Continue to take the same empagliflozin daily dose. Patient switching from separate tab of empagliflozin (10 mg or 25 mg total daily dose) & metformin Take the same daily dose of empagliflozin & metformin already being taken or the nearest therapeutically appropriate dose of metformin. Childn ≥10 yr (GFR ≥60 mL/min) Individualised dosage on the basis of the patient's current regimen, effectiveness, & tolerability. Recommended dose: 1 tab bid. Max daily dose: Empagliflozin 25 mg & metformin 2,000 mg. Adult patient w/ renal impairment eGFR 60-89 mL/min Max daily dose: 3,000 mg for metformin, 25 mg for empagliflozin, 45-59 mL/min Max daily dose: 2,000 mg for metformin, no dose adjustment required for empagliflozin, 30-44 mL/min Max daily dose: 1,000 mg for metformin, no dose adjustment required for empagliflozin.

Should be taken with food: Take w/ meals to reduce GI discomfort.

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

Not to be used in patients w/ type 1 diabetes. Reports of diabetic ketoacidosis; higher risk of ketoacidosis in patients on a very low carbohydrate diet, w/ acute illness, pancreatic disorders suggesting insulin deficiency (eg, type 1 diabetes, history of pancreatitis or pancreatic surgery), insulin dose reduction (including insulin pump failure), alcohol abuse, severe dehydration, w/ history of ketoacidosis. Temporarily discontinue in clinical situations known to predispose to ketoacidosis (eg, prolonged fasting due to acute illness or surgery). Discontinue & institute prompt treatment if Fournier's gangrene is suspected. Assess eGFR before treatment initiation & regularly thereafter. May be used in patients w/ stable chronic heart failure w/ regular monitoring of cardiac & renal function. Caution in patients for whom an empagliflozin-induced drop in BP could pose a risk, eg, patients w/ known CV disease, on anti-hypertensive therapy w/ history of hypotension, elderly ≥75 yr. Reported cases of complicated UTI including pyelonephritis & urosepsis. Carefully monitor vol status & electrolytes in case of conditions that may lead to fluid loss (eg, GI illness). Discontinue at the time of surgery under general, spinal or epidural anaesth; may be restarted no earlier than 48 hr following surgery or resumption of oral nutrition & provided that renal function has been re-evaluated & found to be stable. Avoid use during pregnancy unless clearly needed. Discontinue breastfeeding during treatment. No data available for childn w/ eGFR <60 mL/min/1.73 m² & <10 yr. Regularly monitor renal function in elderly. Metformin: Risk of lactic acidosis especially at acute worsening of renal function or cardiorespiratory illness or sepsis. Increased risk of lactic acidosis w/ administration of iodinated contrast agents. Discontinue metformin prior to or at the time of the imaging procedure & do not restart until at least 48 hr after, provided that renal function has been re-evaluated & found to be stable. Periodically monitor vit B₁₂ in patients w/ risk factors for vit B₁₂ deficiency.

Vag moniliasis, vulvovaginitis, balanitis & other genital infections, UTI (including pyelonephritis & urosepsis), necrotizing fasciitis of the perineum (Fournier's gangrene); nausea, vomiting, diarrhoea, abdominal pain, loss of appetite, constipation; hypoglycaemia (when used w/ sulphonylurea or insulin), lactic acidosis, vit B₁₂ decrease/deficiency, ketoacidosis; LFTs abnormalities, hepatitis; taste disturbance; pruritus, allergic skin reactions (eg, rash, urticaria, erythema), angioedema; vol depletion; increased urination, dysuria; thirst; decreased GFR; increased blood creatinine, haematocrit & serum lipids.

Interference w/ 1,5-anhydroglucitol (1,5-AG) assay. Empagliflozin: May add to the diuretic effect of thiazide & loop diuretics & increase risk of dehydration & hypotension. May increase risk of hypoglycaemia w/ insulin & insulin secretagogues eg, sulphonylureas. May decrease blood lithium levels. Metformin: Increased risk of lactic acidosis w/ alcohol intoxication; iodinated contrast agents; NSAIDs, including selective COX II inhibitors, ACE inhibitors, AIIA & diuretics, especially loop diuretics. Efficacy may be reduced w/ verapamil (OCT1 inhibitor). GI absorption & efficacy may be increased w/ rifampicin (OCT1 inducer). Renal elimination may be decreased w/ OCT2 inhibitors eg, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, & isavuconazole. Efficacy & renal elimination may be altered w/ inhibitors of both OCT1 & OCT2 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.

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