Jardiance Duo

Per 5/500 mg FC tab Empagliflozin 5 mg, metformin HCl 500 mg. Per 12.5/500 mg FC tab Empagliflozin 12.5 mg, metformin HCl 500 mg. Per 12.5/850 mg FC tab Empagliflozin 12.5 mg, metformin HCl 850 mg. Per 12.5/1,000 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, metformin in combination w/ other glucose-lowering products including insulin, & already treated w/ empagliflozin & metformin co-administered as separate tab. Adults w/ type 2 DM & established CV disease to reduce incidence of CV death.

Individualized dosage. 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 inadequately controlled on metformin bd as monotherapy or in combination w/ other products including insulin Initially empagliflozin 5 mg bd & metformin similar to the dose already being taken. Patient tolerating total daily dose of empagliflozin 10 mg & who needs tighter glycemic control May increase to total daily dose of empagliflozin 25 mg. Patient switching from separate empagliflozin (10 or 25 mg total daily dose) & metformin (dose taken bd) tab Give the same daily 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: Starting dose: At most ½ of max dose. Max daily dose: 2,000 mg, 30-44 mL/min Empagliflozin: Should not be initiated. Metformin: Starting dose: At most ½ of max dose. Max daily dose: 1,000 mg.

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/ 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 failure, resp failure, recent MI, shock). Severe renal failure (CrCl <30 mL/min) or eGFR <30 mL/min/1.73 m². Hepatic insufficiency, acute alcohol intoxication, alcoholism.

Do not use in patients w/ type 1 diabetes. Discontinue treatment if ketoacidosis is suspected; consider monitoring & temporary discontinuation in clinical situations predisposing to ketoacidosis (eg, prolonged fasting due to acute illness or surgery); consider monitoring of ketones even if treatment has been interrupted. Increased risk of lactic acidosis. Temporarily discontinue use in case of dehydration. Concomitant use w/ medicinal products that can acutely impair renal function (eg, antihypertensives, diuretics & NSAIDs). Discontinue use prior to or at the time of imaging procedure in patient w/ eGFR >60 mL/min/1.73 m² & 48 hr before iodinated contrast media administration in patients w/ moderate renal impairment; do not reinstitute until at least 48 hr afterwards. Discontinue use & institute prompt treatment if necrotizing fasciitis of the perineum (Fournier's gangrene) is suspected. Assess GFR before treatment initiation & regularly thereafter. Temporarily discontinue use in the presence of conditions that alter renal function. Regularly monitor cardiac & renal function in patients w/ stable chronic heart failure. Contraindicated in patients w/ acute & unstable heart failure. Patients for whom empagliflozin-induced BP drop could pose risk (eg, those w/ known CV disease, on antihypertensive therapy w/ history of hypotension or patients ≥75 yr). Carefully monitor vol status (eg, physical exam, BP measurements, lab tests including haematocrit) & electrolytes in case of conditions that may lead to fluid loss (eg, GI illness). Consider temporary treatment interruption until fluid loss is corrected; & in patients w/ complicated UTI. Discontinue treatment at the time of surgery under general, spinal or epidural anaesth; may restart therapy no earlier than 48 hr following surgery or oral nutrition resumption provided that renal function has been re-evaluated & stable. Monitor vit B₁₂ serum levels in case vit B₁₂ deficiency (eg, anaemia or neuropathy) is suspected. Minor influence on the ability to drive & use machines; avoid hypoglycaemia particularly in combination w/ sulphonylurea &/or insulin. Hepatic injury. Not recommended during pregnancy. Not to be used during breastfeeding. Not recommended for childn <18 yr. Increased risk of vol depletion in elderly ≥75 yr.

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

Empagliflozin: May increase risk of dehydration & hypotension w/ thiazide & loop diuretics. May increase risk of hypoglycaemia w/ insulin & insulin secretagogues (eg, sulphonylureas). Not recommended to monitor glycemic control w/ 1,5-anhydroglucitol assay. May decrease blood lithium levels. Potential risk of decreased efficacy w/ UGT enzyme inducers. Metformin: Increased risk of lactic acidosis w/ alcohol intoxication; intravascular iodinated contrast agents; NSAIDs including selective COX II inhibitors, ACE inhibitors, AIIA & diuretics especially loop diuretics. Efficacy may be reduced w/ OCT1 inhibitors (eg, verapamil). GI absorption & efficacy may be increased w/ OCT1 inducers (eg, rifampicin). Increased plasma conc w/ OCT2 inhibitors (eg, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole). Efficacy & renal elimination may be altered 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.

POM