Jardiance Duo

Per 5 mg/1,000 mg FC tab Empagliflozin 5 mg, metformin HCl 1,000 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 & childn ≥10 yr w/ type 2 DM when treatment w/ both empagliflozin & metformin is appropriate, inadequately controlled w/ metformin or (empagliflozin - for Adults only) alone or in combination w/ other glucose-lowering products including insulin & already treated w/ empagliflozin & metformin co-administered as separate tab. Prevention of CV events by reducing risk of CV death in adults w/ type 2 DM & established CV disease.

Adult w/ normal renal function (GFR ≥90 mL/min) & ped ≥10 yr Individualised dosage. Recommended dose: 1 tab bid. Max daily dose: Empagliflozin 25 mg/metformin 2,000 mg. Patient not adequately controlled on metformin alone or in combination w/ other products Initially empagliflozin 5 mg bid + metformin similar to the dose being taken. May be increased up to 25 mg empagliflozin in patients tolerating total daily dose of empagliflozin 10 mg. Patient already treated w/ empagliflozin Same daily dose of empagliflozin being taken. Patient switching from separate tab of empagliflozin & metformin to Jardiance Duo Same daily dose of empagliflozin & metformin already being taken. Renal impairment w/ eGFR of 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: No dose adjustment.

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 precoma. Acute conditions w/ potential to alter renal function eg, dehydration, severe infection, shock, intravascular administration of iodinated contrast agents. Disease which may cause tissue hypoxia (especially acute disease or worsening of chronic disease) eg, decompensated heart & resp failure, recent MI, shock. Acute alcohol intoxication, alcoholism. Hepatic insufficiency. Severe renal failure (CrCl <30 mL/min or estimated GFR <30 mL/min/1.73 m²).

Discontinue if ketoacidosis, necrotizing fasciitis is suspected; 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. Consider temporary discontinuation for at least 3 days prior to surgery in patients who will undergo scheduled surgery; in clinical situations known to predispose to ketoacidosis; present conditions that alter renal function; until fluid loss is corrected in conditions that may lead to fluid loss; patients w/ complicated UTI. Temporarily discontinue metformin if dehydration (severe diarrhea or vomiting, fever or reduced fluid intake) occurs. Discontinue metformin in suspected symptoms of lactic acidosis; prior to iodinated contrast media administration or at the time of imaging procedure & not restarted until at least 48 hr provided that renal function has been re-evaluated & stable. Not to be used in patients w/ type 1 diabetes. Diabetic ketoacidosis; lactic acidosis. Complicated UTI including pyelonephritis & urosepsis. Patients on 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, & history of ketoacidosis; heart failure; for whom empagliflozin-induced drop in BP could pose a risk eg patients w/ known CV disease, on antihypertensive therapy w/ history of hypotension or ≥75 yr. Assess patients for ketoacidosis immediately if symptoms occur regardless of blood glucose level; estimated GFR before treatment & regularly (at least annually) thereafter. Monitor ketones; cardiac & renal (every 3-6 mth in patients at increased risk of renal impairment progression & elderly) function in patients w/ stable chronic heart failure; vol status (eg, physical exam, BP measurements, lab tests including haematocrit) & electrolytes; vit B₁₂ serum levels in case of suspicion of deficiency (eg, anaemia or neuropathy). Evaluate treated patients for necrotizing fasciitis w/ pain or tenderness, erythema, genital or perineal swelling, fever, malaise. Concomitant use w/ medicinal products that can acutely impair renal function eg, antihypertensives, diuretics & NSAIDs; medicinal products that can cause lactic acidosis. Avoid use during pregnancy. Discontinue breastfeeding during treatment. Childn <10 yr. Not recommended in elderly ≥85 yr. Elderly ≥75 yr (increased risk of vol depletion).

Vag moniliasis, vulvovaginitis, balanitis & other genital infections, UTI (including pyelonephritis & urosepsis), perineal necrotizing fasciitis (Fournier's gangrene); nausea, vomiting, diarrhoea, abdominal pain, loss of appetite, constipation; hypoglycaemia (when used w/ sulphonylurea or insulin), lactic acidosis, decrease/deficiency in vit B₁₂, ketoacidosis; abnormal LFTs, 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.

Empagliflozin: Additive diuretic effect & increased risk of dehydration & hypotension of thiazide & loop diuretics. Increased risk of hypoglycaemia w/ insulin & insulin secretagogues eg, sulphonylureas. Interference w/ 1,5-anhydroglucitol assay. Decreased blood lithium levels. Metformin: Increased risk of lactic acidosis w/ alcohol intoxication; medicinal products affecting renal function eg, NSAIDs including COX-2 inhibitors, ACE inhibitors, AIIA & diuretics, especially loop diuretics. Concomitant use w/ iodinated contrast agents. May reduce efficacy w/ organic cation transporter (OCT) 1 inhibitors eg, verapamil. May increase GI absorption & efficacy w/ OCT1 inducers eg, rifampicin. May decrease renal elimination w/ OCT2 inhibitors eg, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole. May alter efficacy & renal elimination w/ both 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.

NDD