Jardiance Duo

Jardiance Duo

empagliflozin + metformin

Manufacturer:

Boehringer Ingelheim

Distributor:

DKSH

Marketer:

Boehringer Ingelheim
Concise Prescribing Info
Contents
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
Indications/Uses
Adjunct to diet & exercise to improve glycaemic control in adult patients 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 patients w/ type 2 DM & established CV disease.
Dosage/Direction for Use
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. Switching from separate tab of empagliflozin & metformin Initiate based on current empagliflozin & metformin dose. Inadequately controlled on max tolerated metformin dose or in combination w/ insulin Empagliflozin 5 mg bd & current metformin dose. Renal impairment eGFR 60-89 mL/min Max: Metformin 3,000 mg & empagliflozin 25 mg daily, 45-59 mL/min Initially, metformin not >1,000 mg. Max: Metformin 2,000 mg daily, 30-44 mL/min Initially, metformin not >500 mg. Max: Metformin 1,000 mg daily.
Administration
Should be taken with food: Take w/ meals to reduce GI discomfort.
Contraindications
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, 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 (CrCl <30 mL/min or eGFR <30 mL/min/1.73 m2)] 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.
Special Precautions
Not to be used in patients w/ type 1 diabetes. Discontinue use if ketoacidosis, necrotizing infection, Fournier's gangrene are suspected & recurrent UTI occurs. Increased risk of lactic acidosis. Patients on very low carbohydrate diet, w/ acute illness, pancreatic disorders suggesting insulin deficiency, insulin dose reduction, alcohol abuse, severe dehydration, history of ketoacidosis. Heart failure; risk of vol depletion in patients w/ known CV disease, on antihypertensive therapy w/ history of hypotension; conditions leading to fluid loss eg, GI illness. Monitor ketones in situations known to predispose ketoacidosis eg, prolonged fasting due to acute illness or surgery. Assess renal function prior to & regularly thereafter. Perform routine serum vit B12 measurement at 2- to 3-yr intervals. Concomitant use w/ antihypertensives, diuretics & NSAIDs. Combination w/ glucagon like peptide-1 analogues. Discontinue treatment prior to, during or 48 hr after administration of iodinated contrast media & surgery. Counsel patients on routine preventative foot care. Hepatic insufficiency or injury. Avoid use during pregnancy. Not to be used during lactation. Not recommended in childn <18 yr. Not recommended in elderly ≥85 yr.
Adverse Reactions
Hypoglycaemia; GI symptoms. Vag moniliasis, vulvovaginitis, balanitis, other genital infection, UTI; taste disturbance; allergic skin reactions eg, rash, erythema, urticaria; increased urination; thirst; increased serum lipids.
Drug Interactions
Empagliflozin: Increased risk of dehydration & hypotension w/ thiazide & loop diuretics. Increased risk of hypoglycaemia w/ insulin & insulin secretagogues eg, sulfonylureas. Increased overall exposure w/ gemfibrozil, rifampicin or probenecid. Interference w/ 1,5-anhydroglucitol assay. Metformin: Increased risk of lactic acidosis w/ alcohol, 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 by nifedipine. Reduced efficacy w/ verapamil. Increased GI absorption & efficacy w/ rifampicin. Increased plasma conc w/ dolutegravir, crizotinib, olaparib, daclatasvir, vandetanib.
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 mg/850 mg FC tab
Packing/Price
60's
Form
Jardiance Duo 12.5 mg/500 mg FC tab
Packing/Price
60's
Form
Jardiance Duo 5 mg/500 mg FC tab
Packing/Price
60's
Form
Jardiance Duo 12.5 mg/1,000 mg FC tab
Packing/Price
60's
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