Glyxambi

Per 10 mg/5 mg FC tab Empagliflozin 10 mg, linagliptin 5 mg. Per 25 mg/5 mg FC tab Empagliflozin 25 mg, linagliptin 5 mg

Adjunct to diet & exercise to improve glycaemic control in adults w/ type 2 DM.

Initially empagliflozin 10 mg/linagliptin 5 mg once daily. Patient tolerating 10 mg/5 mg dose & requiring additional glycaemic control Dose may be increased to empagliflozin 25 mg/linagliptin 5 mg once daily.

May be taken with or without food.

Hypersensitivity. Patients on dialysis.

Discontinue use if diabetic ketoacidosis; necrotizing fasciitis; pancreatitis; bullous pemphigoid is suspected. Consider temporary discontinuation of treatment for at least 3 days prior to surgery in patients who will undergo scheduled surgery. Temporary interruption of treatment until fluid loss is corrected; in patients w/ complicated UTI. Not to be used in patients w/ type 1 diabetes; ketoacidosis; severe infection or accident. Diabetic ketoacidosis. Perineal necrotising fasciitis (Fournier's gangrene). Acute pancreatitis. Hypoglycaemia. Complicated UTI including pyelonephritis & urosepsis. Bacterial & fungal infection on genital area & urinary tract. May increase risk of severe joint pain. 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 pump failure), alcohol abuse, severe dehydration, & history of ketoacidosis; for whom empagliflozin-induced decrease in BP could pose a risk eg, those w/ known CV disease, on antihypertensive therapy w/ history of hypotension, or ≥75 yr. Immediately assess patients if symptoms of ketoacidosis occur regardless of blood glucose level. Consider monitoring for ketoacidosis & temporarily discontinue treatment in clinical situations known to predispose to ketoacidosis. Monitor vol status (eg, physical exam, BP measurements, lab tests including haematocrit) & electrolytes in case of conditions leading to fluid loss occur. Evaluate patients who present w/ pain or tenderness, erythema, genital or perineal area swelling, fever, malaise for necrotizing fasciitis. Assess renal function prior to initiation of treatment & periodically during treatment ie, at least yrly. Ensure risk factors for ketoacidosis are resolved prior to restarting treatment. In combination w/ sulphonylurea or insulin (consider dose reduction of sulphonylurea or insulin). Not to be taken w/ alcohol beverage. Not recommended in patients w/ estimated GFR <30 mL/min/1.73 m². Avoid use during pregnancy. Discontinue breast-feeding during treatment. Not recommended in childn <18 yr & elderly ≥85 yr. Elderly ≥75 yr (increased risk of vol depletion).

Vag moniliasis, vulvovaginitis, balanitis & other genital infections, UTI (including pyelonephritis & urosepsis), perineal necrotizing fasciitis (Fournier's gangrene), nasopharyngitis; hypersensitivity, angioedema, urticaria; hypoglycaemia (when used w/ sulphonylurea or insulin), ketoacidosis; increased urination, dysuria; cough; rash, pruritus, bullous pemphigoid; constipation, pancreatitis, mouth ulceration; vol depletion; thirst; decreased GFR, increased blood creatinine, lipase, amylase, haematocrit & serum lipids.

Increased risk of hypoglycaemia w/ insulin & sulphonylureas. Interference w/ 1,5-anhydroglucitol assay. Empagliflozin: Additive diuretic effect & increased risk of dehydration & hypotension of thiazide & loop diuretics. Decreased blood lithium levels. Decreased efficacy w/ uridine 5'-diphospho-glucuronosyltransferases enzyme inducers. Linagliptin: Decreased exposure w/ strong P-gp or CYP3A4 inducers (rifampicin).

Antidiabetic Agents

A10BD19 - linagliptin and empagliflozin ; Belongs to the class of combinations of oral blood glucose lowering drugs. Used in the treatment of diabetes.

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