Jardiance Duo

Per 5 mg/500 mg FC tab Empagliflozin 5 mg, metformin HCl 500 mg. Per 5 mg/1 g FC tab Empagliflozin 5 mg, metformin HCl 1 g. Per 12.5 mg/500 mg FC tab Empagliflozin 12.5 mg, metformin HCl 500 mg. Per 12.5 mg/1 g FC tab Empagliflozin 12.5 mg, metformin HCl 1 g

Adjunct to diet & exercise to improve glycaemic control in adults w/ type 2 DM when treatment w/ both empagliflozin & metformin is appropriate. 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/ the current standard care.

Recommended dose: 1 tab bid. Adult w/ normal renal function (GFR ≥90 mL/min) Max daily dose: 25 mg/2,000 mg. 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. 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. Higher risk of ketoacidosis include patients on a very low carbohydrate diet, w/ an 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 if Fournier's gangrene is suspected. Assess GFR before treatment initiation & regularly thereafter. Patients for whom an empagliflozin-induced drop in BP could pose a risk, eg, patients w/ known CV disease, on anti-hypertensive therapy w/ a history of hypotension. Complicated UTI including pyelonephritis & urosepsis. Monitor vol status & electrolytes. Discontinue at the time of surgery under general, spinal or epidural anesth; 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 in pregnancy. Discontinue during lactation. Elderly ≥75 yr. Not recommended for childn <18 yr. Metformin: Increased risk of lactic acidosis prior to administration of iodinated contrast agents. Discontinue prior to or at the time of the imaging procedure & not restarted until at least 48 hr after, provided that renal function has been re-evaluated & found to be stable. 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; hypoglycemia (when used w/ sulphonylurea or insulin), lactic acidosis, decreased vit B₁₂ absorption, 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, hematocrit & serum lipids.

Interference w/ 1,5-anhydroglucitorl (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. Adversely affect renal function which may increase risk of lactic acidosis w/ NSAIDs, including selective cyclo-oxygenase (COX) II inhibitors, ACE inhibitors, AIIA & diuretics, especially loop diuretics. May reduced efficacy w/ verapamil. May increase GI absorption & efficacy w/ rifampicin. May decrease renal elimination w/ cimetidine, dolutegravir, ranolazine, trimethoprime, vandetanib, & isavuconazole. May alter efficacy & renal elimination w/ 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.

Rx