Jardiance Duo

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.

Adult 1 tab bd. Max: Empagliflozin 25 mg & metformin 2,000 mg daily. Treatment-naive 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 dose being taken. May be increased to total daily dose: 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.

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

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 causing tissue hypoxia eg, cardiac or resp failure, recent MI, shock, pulmonary embolism, acute significant blood loss, sepsis, gangrene, pancreatitis; during or immediately following surgery where insulin is essential, elective major surgery. Patients w/ CKD stage 4 or 5 (severe renal impairment eg, on dialysis; eGFR <30 mL/min/1.73 m² or CrCl <30 mL/min) or eGFR persistently <45 mL/min/1.73 m² or CrCl persistently <45 mL/min (CKD stage 3B). Hepatic impairment, acute alcohol intoxication, alcoholism. Lactation.

Not to be used in type 1 diabetes. Discontinue use if ketoacidosis, necrotizing fasciitis of the perineum (Fournier's gangrene) are suspected; in cases of recurrent UTI. Increased risk of lactic acidosis. Patients on very low carbohydrate diet, acute illness, pancreatic disorders suggesting insulin deficiency, insulin dose reduction, alcohol abuse, severe dehydration & history of ketoacidosis; acute & unstable heart failure. Vol-depletion risk in patients w/ CV disease, on antihypertensive therapy w/ history of hypotension; conditions leading to fluid loss eg, GI illness. Monitor ketones in situations predisposing ketoacidosis eg, prolonged fasting due to acute illness or surgery. Assess GFR prior to & at least annually thereafter. Periodic monitoring of serum vit B₁₂ levels. Discontinue use prior to, during & until 48 hr after administration of iodinated contrast media; during surgery. Counsel patients on routine preventive foot care. Concomitant use w/ antihypertensives, diuretics & NSAIDs. Combination w/ glucagon like peptide-1 analogues. Hepatic injury. Avoid use during pregnancy. Not to be used during lactation. Not recommended in childn <18 yr. Not recommended in elderly ≥75 yr.

Hypoglycaemia; GI symptoms. Vag moniliasis, vulvovaginitis, balanitis, other genital infection, UTI eg, pyelonephritis & urosepsis; vit B₁₂ deficiency; taste disturbance; constipation; allergic skin reactions eg, rash, erythema, urticaria; increased urination; thirst; increased serum lipids.

Empagliflozin: Increased risk of dehydration & hypotension w/ thiazide & loop diuretics. Increased risk of hypoglycaemia w/ insulin & insulin secretagogues eg, sulfonylureas. Interference w/ 1,5-anhydroglucitol assay. Decreased blood lithium levels. Metformin: Increased risk of lactic acidosis w/ alcohol; NSAIDs including selective COX-II inhibitors, ACE inhibitors, AIIA, loop diuretics. Monitor blood glucose w/ glucocorticoids, local & systemic tetracosactides, β₂-agonists, danazol, high-dose chlorpromazine. Decreased blood glucose levels w/ ACE inhibitors. Affected glucose control w/ Ca-channel blockers. Potentiated antihyperglycaemic action w/ β-blockers. Reduced clearance w/ cimetidine. Increased elimination rate of vit K antagonists. Enhanced absorption w/ nifedipine. Reduced efficacy w/ verapamil. Increased GI absorption & efficacy w/ rifampicin. Increased plasma conc w/ dolutegravir, crizotinib, olaparib, daclatasvir, vandetanib.

Antidiabetic Agents

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

B