Jardiance Duo

Jardiance Duo

empagliflozin + metformin

Manufacturer:

Boehringer Ingelheim

Distributor:

Metro Drug

Marketer:

Boehringer Ingelheim
Concise Prescribing Info
Contents
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
Indications/Uses
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.
Dosage/Direction for Use
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.
Administration
Should be taken with food: Take w/ meals to reduce GI discomfort.
Contraindications
Hypersensitivity to empagliflozin or metformin. 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. Severe renal failure (CrCl <30 mL/min or eGFR <30 mL/min/1.73 m2).
Special Precautions
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. Acute & unstable heart failure. 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.
Adverse Reactions
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; hypoglycemia (when used w/ sulphonylurea or insulin), lactic acidosis, decreased vit B12 absorption, ketoacidosis; abnormal liver function tests, hepatitis; taste disturbance; pruritus, allergic skin reactions, angioedema; vol depletion; increased urination, dysuria; thirst; decreased GFR; increased blood creatinine, hematocrit & serum lipids.
Drug Interactions
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. 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, angiotensin II receptor antagonists & 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.
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 12.5 mg/1 g FC tab
Packing/Price
30's (P1,029.3/box)
Form
Jardiance Duo 12.5 mg/500 mg FC tab
Packing/Price
30's (P949.2/box)
Form
Jardiance Duo 5 mg/1 g FC tab
Packing/Price
30's (P1,027.5/box)
Form
Jardiance Duo 5 mg/500 mg FC tab
Packing/Price
30's (P699.9/box)
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