Jardiance Duo

Jardiance Duo

empagliflozin + metformin

Manufacturer:

Boehringer Ingelheim

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
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
Indications/Uses
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. Prevention of CV events & reduce risk of CV death in adults w/ type 2 DM & established CV disease.
Dosage/Direction for Use
Adult w/ normal renal function (GFR ≥90 mL/min) Individualised dose. Recommended dose: 1 tab bid. Max daily dose: 25 mg/2,000 mg. Patients not adequately controlled on metformin alone or in combination w/ other products Initially empaglifozin 5 mg bid + metformin similar to the dose being taken. May be increased up to 25 mg empaglifozin in patients tolerating a total daily dose of empaglifozin 10 mg. Patients already treated w/ empagliflozin Same daily dose of empagliflozin being taken. Patients switching from separate tab of empagliflozin & metformin to Jardiance Duo Same daily dose of empagliflozin & metformin already being taken. Renal impairment eGFR of 60-89 mL/min Max daily dose: 3,000 mg metformin; 25 mg empagliflozin, 45-59 mL/min Recommended dose: 1,000 mg metformin bid. Max daily dose: 2,000 mg metformin.
Administration
Should be taken with food: Take w/ meals to reduce GI discomfort.
Contraindications
Hypersensitivity. Any type of acute metabolic acidosis eg, lactic acidosis & diabetic ketoacidosis; diabetic pre-coma. Disease which may cause tissue hypoxia (especially acute disease or worsening of chronic disease) eg, decompensated heart failure, resp failure, recent MI, shock. Hepatic insufficiency, acute alcohol intoxication, alcoholism. Moderate (stage 3b) & severe renal failure or renal dysfunction (CrCl <45 mL/min or eGFR <45 mL/min/1.73 m2). 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 (especially acute disease or worsening of chronic disease) eg, decompensated heart failure, resp failure, recent MI, shock.
Special Precautions
Not to be administered in patients w/ type 1 diabetes. Discontinue if CrCl fall <45 mL/min or eGFR fall <45 mL/min/1.73 m2, diabetic ketoacidosis, necrotizing fasciitis is suspected. Assess patients for ketoacidosis immediately if symptoms occur regardless of blood glucose level. 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, & w/ history of ketoacidosis. Consider temporary discontinuation for at least 3 days prior to surgery for patients who undergo scheduled surgery; in clinical situations known to predispose to ketoacidosis; in present conditions that alter renal function; until fluid loss is corrected; in patients w/ complicated UTI. Monitor ketones, even in interrupted treatment. Lactic acidosis. Temporarily discontinue metformin if dehydration (severe diarrhea or vomiting, fever or reduced fluid intake) occurs. Concomitant use w/ medicinal products that can acutely impair renal function (eg, antihypertensives, diuretics & NSAIDs). Discontinue metformin in suspected symptoms of lactic acidosis; prior to iodinated contrast media administration or at the time of the imaging procedure & not restarted until at least 48 hr provided that renal function has been re-evaluated & stable. Evaluate treated patients who present w/ pain or tenderness, erythema, genital or perineal swelling, fever, malaise for necrotizing fasciitis. Assess GFR before treatment & regularly thereafter. Regularly monitor cardiac & renal function in patients (every 3-6 mth in elderly) w/ stable chronic heart failure. Patients for whom an empagliflozin-induced drop in BP could pose a risk eg, patients w/ known CV disease, on antihypertensive therapy w/ history of hypotension or patients ≥75 yr. Carefully monitor vol status (eg, physical exam, BP measurements, laboratory tests including hematocrit) & electrolytes. Discontinue therapy 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. Avoid use during pregnancy & discontinue during lactation. Increased risk of vol depletion in patients ≥75 yr. Not recommended in childn <18 yr & elderly ≥85 yr.
Adverse Reactions
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; hypoglycaemia, lactic acidosis, decreased vit B12 absorption, ketoacidosis; liver function tests 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.
Drug Interactions
Empaglifozin: Additive diuretic effect & increase the risk of dehydration & hypotension of thiazide & loop diuretics. May increase risk of hypoglycaemia w/ insulin & insulin secretagogues. eg, sulphonylureas. Interference w/ 1,5-anhydroglucitol (1,5-AG) assay. Metformin: Increased risk of lactic acidosis in acute alcohol intoxication or medicinal products that can affect renal function eg, NSAIDs including COX-2 inhibitors, ACE inhibitors, angiotensin II receptor antagonists & diuretics, especially loop diuretics. Concomitant use w/ iodinated contrast agents. May reduce efficacy w/ organic cation transporters (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.
MIMS Class
Antidiabetic Agents
ATC Classification
A10BD20 - metformin and empagliflozin ; Belongs to the class of combinations of oral blood glucose lowering drugs. Used in the treatment of diabetes.
Presentation/Packing
Form
Jardiance Duo FC tab 12.5 mg/1000 mg
Packing/Price
6 × 10's
Form
Jardiance Duo FC tab 5 mg/1000 mg
Packing/Price
6 × 10's
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