Jardiance

Jardiance

empagliflozin

Manufacturer:

Boehringer Ingelheim

Distributor:

DKSH
Concise Prescribing Info
Contents
Empagliflozin
Indications/Uses
Type 2 DM as monotherapy in adults inadequately controlled by diet & exercise alone & for whom metformin is inappropriate due to intolerance. Add-on combination therapy w/ other glucose-lowering drugs eg, insulin & when diet & exercise is inappropriate. Reduction of CV death risks in patients w/ type 2 DM & established CV disease.
Dosage/Direction for Use
Monotherapy & add-on combination therapy Initially 10 mg once daily. Patient tolerating empagliflozin 10 mg once daily Dose may be increased to max: 25 mg once daily.
Administration
May be taken with or without food: Swallow whole w/ water.
Contraindications
Hypersensitivity. Patients w/ severe renal impairment (eGFR <30 ml/min/1.73m2), end-stage renal disease & on dialysis.
Special Precautions
Not to be used in type 1 diabetes or diabetic ketoacidosis. Discontinue use if ketoacidosis, necrotizing infection, Fournier's gangrene are suspected. Patients w/ very low carbohydrate diet, acute illness, pancreatic disorders suggesting insulin deficiency, reduced insulin dose, alcohol abuse, severe dehydration & history of ketoacidosis. Vol-depletion risk in patients w/ CV disease, on antihypertensive therapy w/ history of hypotension or ≥75 yr; conditions leading to fluid loss eg, GI illness; complicated UTI eg, pyelonephritis or urosepsis; cardiac failure (NYHA class I-IV); +ve glucose urine test. Assess renal function prior to & periodically during treatment. Monitor ketones in situations known to predispose ketoacidosis eg, prolonged fasting due to acute illness or surgery. Interference w/ 1,5-anhydroglucitol assay. Counsel patients on routine prevention foot-care. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May affect ability to drive & use machines. Not to be initiated if eGFR persistently <45 mL/min/1.73 m2 or CrCl persistently <45 mL/min. Not to be used in patients w/ end-stage renal disease or on dialysis. Not recommended in severe hepatic impairment. Hepatic injury. Not recommended during 2nd & 3rd trimester of pregnancy. Not to be used during lactation. Childn & adolescents. Not recommended in elderly ≥85 yr.
Adverse Reactions
Hypoglycaemia. Vag moniliasis, vulvovaginitis, balanitis, other genital infection, UTI eg, pyelonephritis & urosepsis; thirst; generalised pruritus, allergic skin reactions eg, rash, urticaria; increased urination; increased serum lipids.
Drug Interactions
Increased risk of dehydration & hypotension w/ thiazide & loop diuretics. Increased risk of hypoglycaemia w/ insulin & insulin secretagogues eg, sulphonylureas. Decreased efficacy by UGT inducers.
MIMS Class
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 25 mg
Packing/Price
30's
Form
Jardiance FC tab 10 mg
Packing/Price
30's
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