Jardiance

Monotherapy or in combination w/ other glucose-lowering medicinal products including insulin for type 2 DM to improve glycaemic control when diet & exercise alone do not provide adequate glycaemic control in adults & childn ≥10 yr. Adjunct to diet, exercise & standard care therapy to reduce incidence of CV death in adult patients w/ type 2 DM & established CV disease who have inadequate glycemic control. Adult patients w/ heart failure (NYHA class II-IV) w/ or w/o type 2 DM to reduce risk of CV death & hospitalisation for heart failure. Reduce risk of sustained decline in eGFR, end-stage kidney disease, CV death & hospitalisation in adults w/ CKD at risk of progression.

Type 2 DM Adult Recommended starting dose: 10 mg once daily for monotherapy & add-on combination therapy w/ other medicinal products including insulin. Patient tolerating empagliflozin 10 mg once daily & need tighter glycaemic control May be increased to 25 mg once daily. Max daily dose: 25 mg. In combination w/ sulphonylurea or insulin Consider lower dose of sulphonylurea or insulin to reduce risk of hypoglycaemia. Childn ≥10 yr Recommended starting dose: 10 mg once daily. Paed patient tolerating empagliflozin 10 mg once daily & requiring additional glycaemic control May be increased to 25 mg once daily. Heart failure & CKD 10 mg once daily. Renal impairment (eGFR <45 mL/min/1.73 m²) Recommended dose: 10 mg & consider additional glucose lowering treatment if needed.

May be taken with or without food: Swallow whole w/ water.

Hypersensitivity.

Not to be used in patients w/ type 1 diabetes. Discontinue use if ketoacidosis; necrotizing fasciitis of the perineum (Fournier's gangrene) are suspected & promptly institute treatment. Ketoacidosis & glucosuria may be prolonged after discontinuation in some patients. Higher risk of ketoacidosis in patients on a 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; alcohol abuse; severe dehydration; history of ketoacidosis. Consider monitoring of ketones even if treatment has been interrupted in clinical situations known to predispose to ketoacidosis (eg, prolonged fasting due to acute illness or surgery). Patients for whom a BP drop could pose a risk (eg, patients w/ known CV disease, on anti-hypertensive therapy w/ a history of hypotension). May lead to modest BP decrease; carefully monitor vol status (eg, physical exam, BP measurements, lab tests including haematocrit) & electrolytes. Consider temporary treatment interruption until fluid loss is corrected; in patients w/ complicated UTI including pyelonephritis & urosepsis. May test +ve for glucose in urine lab assessments. Contains lactose; not to be taken by patients w/ rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Minor influence on the ability to drive & use machines. Not recommended to initiate treatment in patients on dialysis. Assess renal function prior to initiation & periodically during treatment; prior to initiation of any concomitant medicinal product that may have -ve impact on renal function. Not recommended in patients w/ severe hepatic impairment. Reported cases of hepatic injury. Avoid use during early pregnancy; not recommended during 2nd & 3rd trimester of pregnancy. Not to be used during breast-feeding. No data are available for childn w/ eGFR <60 mL/min/1.73 m² & <10 yr. Safety & effectiveness for the treatment of heart failure & CKD have not been established in childn <18 yr. Increased risk of vol depletion in elderly ≥75 yr.

Hypoglycaemia (when used w/ sulphonylurea or insulin). Vag moniliasis, vulvovaginitis, balanitis & other genital infection, UTI (including pyelonephritis & urosepsis); constipation; generalised pruritus, rash; increased serum lipids. Type 2 DM: Thirst; increased urination; urticaria (paed). Heart failure: Vol depletion.

May add to the diuretic effect of thiazide & loop diuretics, & may increase risk of dehydration & hypotension. Increased risk of hypoglycaemia w/ insulin & insulin secretagogues (eg, sulphonylureas). Not recommended to monitor glycemic control w/ 1,5-anhydroglucitol assay. May decrease blood lithium levels through increased renal lithium elimination. Potential risk of decreased efficacy w/ UGT enzyme inducers.

Antidiabetic Agents / Other Cardiovascular Drugs

A10BK03 - empagliflozin ; Belongs to the class of sodium-glucose co-transporter 2 (SGLT2) inhibitors. Used in the treatment of diabetes.

POM