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Jardiance

Jardiance

empagliflozin

Manufacturer:

Boehringer Ingelheim

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Empagliflozin
Indications/Uses
Adjunct to diet & exercise to improve glycaemic control in adults & ped ≥10 yr w/ type 2 DM. Reduce risk of CV death in adults w/ type 2 DM & established CV disease. Reduce risk of CV death & hospitalization for heart failure in adults w/ heart failure. Reduce risk of sustained decline in eGFR, end-stage kidney disease, CV death, & hospitalization in adults w/ CKD at risk of progression.
Dosage/Direction for Use
Adult & ped ≥10 yr Recommended dose: 10 mg once daily in the morning. Glycemic control in type 2 DM Dose may be increased to 25 mg once daily for additional glycaemic control.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Rare hereditary conditions.
Special Precautions
Discontinue treatment if ketoacidosis; perineal necrotizing fasciitis (Fournier's gangrene) is suspected. Consider temporary discontinuation of treatment for at least 3 days prior to surgery in patients who will undergo scheduled surgery; in clinical situations known to predispose to ketoacidosis eg, prolonged fasting due to acute illness or post-surgery (consider monitoring for ketoacidosis &/or ketones). Consider temporary treatment interruption until fluid loss is corrected; in patients w/ complicated UTI. Not to be used in patients w/ type 1 diabetes; severe infection & accident. Not recommended for use to improve glycemic control in patients w/ type 2 DM & those w/o established CV disease or risk factors w/ eGFR <30 mL/min/1.73 m2. Not recommended for treatment of CKD in patients w/ polycystic kidney disease or those requiring or w/ recent history of IV immunosuppressants or >45 mg prednisone or equiv for kidney disease. Ketoacidosis. Perineal necrotizing fasciitis (Fourier's gangrene). Complicated UTI including pyelonephritis & urosepsis. Bacterial & fungal infection on genital area & urinary tract. 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 & history of ketoacidosis; for whom empagliflozin-induced drop in BP could pose risk eg, patients w/ known CV disease, on antihypertensives w/ history of hypotension or patients ≥75 yr. Adults w/ eGFR <20 mL/min/1.73 m2 or on dialysis. Immediately assess patients for ketoacidosis if symptoms occur regardless of blood glucose level. Ensure risk factors for ketoacidosis are resolved prior to restarting treatment. Carefully monitor vol status (eg, physical exam, BP measurements, lab test including haematocrit) & electrolytes in case of conditions that may lead to fluid loss occur. Evaluate treated patients w/ pain or tenderness, erythema, genital or perineal area swelling, fever, malaise for necrotizing fasciitis. Assess renal function prior to initiation & periodically during treatment ie, at least yrly. Not to be taken by patients w/ rare hereditary conditions of galactose intolerance eg, galactosaemia. Not to be taken w/ alcohol beverage. Renal impairment. Avoid use during pregnancy. Discontinue breastfeeding during treatment. Ped patients <10 yr. Elderly ≥75 yr (increased risk of vol depletion).
Adverse Reactions
Vag moniliasis, vulvovaginitis, balanitis & other genital infections, UTI (including pyelonephritis & urosepsis), perineal necrotizing fasciitis (Fournier's gangrene); hypoglycaemia (when used w/ sulphonylurea or insulin), ketoacidosis; constipation; pruritus, allergic skin reactions (eg, rash, urticaria), angioedema; vol depletion; increased urination, dysuria; thirst; decreased GFR, increased blood creatinine, haematocrit & serum lipids.
Drug Interactions
Additive diuretic effect & increased risk of dehydration & hypotension w/ thiazide & loop diuretics. Increased risk of hypoglycaemia w/ insulin & insulin secretagogues eg, sulphonylureas. Interference w/ 1,5-anhydroglucitol (1,5-AG) assay. Decreased blood lithium levels.
MIMS Class
Antidiabetic Agents
ATC Classification
A10BK03 - empagliflozin ; Belongs to the class of sodium-glucose co-transporter 2 (SGLT2) inhibitors. Used in the treatment of diabetes.
Presentation/Packing
Form
Jardiance FC tab 10 mg
Packing/Price
3 × 10's
Form
Jardiance FC tab 25 mg
Packing/Price
3 × 10's
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