Jardiance Duo

Jardiance Duo

empagliflozin + metformin

Manufacturer:

Boehringer Ingelheim

Marketer:

Boehringer Ingelheim
Concise Prescribing Info
Contents
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
Indications/Uses
Adults w/ type 2 DM as an adjunct to diet & exercise to improve glycaemic control in patients inadequately controlled on their maximally tolerated dose of metformin alone; in patients already being treated w/ the combination of empagliflozin & metformin as separate tab.
Dosage/Direction for Use
Individualised dosage. Max daily dose: 25/2,000 mg. Patient not adequately controlled on metformin alone Initially empagliflozin 5 mg twice daily + metformin similar to the dose already being taken. May be increased to a total daily dose of empagliflozin 25 mg in patients tolerating a total daily dose of empagliflozin 10 mg. Patient switching from separate tab to Jardiance Duo Same daily dose of empagliflozin & metformin already being taken. Recommended dose: 1 tab twice daily.
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. Acute alcohol intoxication, alcoholism. Major surgery. Hepatic insufficiency. Moderate & severe renal failure or renal dysfunction (CrCl <60 mL/min or eGFR <60 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.
Special Precautions
Should not be used 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); if necrotizing fascitiis is suspected; in cases of recurrent UTI. Patients on very low carbohydrate diet, w/ acute illness, pancreatic disorders suggesting insulin deficiency, insulin dose reduction, alcohol abuse, severe dehydration & w/ history of ketoacidosis. Temporarily discontinue use in case of dehydration. Increased risk of lactic acidosis. Discontinue metformin prior to or at the time of the imaging procedure & not restarted until at least 48 hr after. Evaluate for necrotizing fasciitis in patients w/ pain or tenderness, erythema, swelling in the genital or perineal area, fever, malaise. Assess GFR before treatment initiation & regularly thereafter. Regularly monitor of cardiac & renal function in patients w/ stable chronic heart failure. Contraindicated in patients w/ acute & unstable heart failure. Carefully monitor vol status & 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 & not restarted until at least 48 hr, provided that renal function has been re-evaluated & found to be stable. Elevated haematocrit. Positive test for glucose in the urine. Regularly examine the feet & counsel all diabetic patients on routine preventative footcare. Perform routine serum vit B12 measurement at 2- to 3-yr intervals. Pregnancy. Discontinue breast feeding during treatment. Not recommended for use in childn < 18 yr. Elderly ≥85 yr; increased risk of vol depletion in elderly ≥75 yr.
Adverse Reactions
Hypoglycaemia; GI symptoms. Vag moniliasis, vulvovaginitis, balanitis & other genital infection, UTI (including pyelonephritis & urosepsis); thirst; taste disturbance; pruritus (generalised), rash; increased urination; serum lipid increased.
Drug Interactions
Empagliflozin: Increased risk of dehydration & hypotension w/ thiazide & loop diuretics. Increased risk of hypoglycaemia w/ insulin & insulin secretagogues eg, sulfonylureas. Metformin: Increased risk of lactic acidosis w/ alcohol intoxication, intravascular iodinated contrast media, NSAIDs (including selective COX II inhibitors), ACE inhibitors, AIIA & diuretics (especially loop diuretics). Reduced efficacy w/ inhibitors of OCT1 (eg, verapamil). Increased GI absorption & efficacy w/ inducers of OCT1 (eg, rifampicin). Increased metformin plasma conc w/ inhibitors of OCT2 (eg, cimetidine, dolutegravir, ranolazine, trimethoprime, vandetanib, isavuconazole). May alter efficacy & renal elimination of metformin w/ inhibitors of both OCT1 & OCT2 (eg, crizotinib, olaparib).
MIMS Class
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 12.5/850 mg FC tab
Packing/Price
3 × 10's
Form
Jardiance Duo 12.5/500 mg FC tab
Packing/Price
3 × 10's
Form
Jardiance Duo 12.5/1,000 mg FC tab
Packing/Price
3 × 10's
Form
Jardiance Duo 5/500 mg FC tab
Packing/Price
3 × 10's
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