Glyxambi

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

Adjunct to diet & exercise to improve glycemic control in adults w/ type 2 DM when treatment w/ both empagliflozin & linagliptin is appropriate.

Recommended dose: 10/5 mg once daily in the morning. Patient tolerating Glyxambi May increase dose to 25/5 mg once daily.

May be taken with or without food.

Hypersensitivity.

Not recommended for patients w/ type 1 diabetes or for diabetic ketoacidosis. Immediately assess patients for ketoacidosis if symptoms (eg, nausea, vomiting, anorexia, abdominal pain, excessive thirst, difficulty breathing, confusion, unusual fatigue, sleepiness) occur. Consider monitoring of ketones even if treatment has been interrupted. Discontinue use if ketoacidosis; necrotizing fasciitis of the perineum (Fournier's gangrene) are suspected. Patients w/ history of pancreatitis. Discontinue use if pancreatitis is suspected; do not restart if acute pancreatitis is confirmed. May lead to a modest BP decrease. Patients w/ known CV disease; those on antihypertensive therapy w/ history of hypotension. Carefully monitor vol status & electrolytes in case of conditions that may lead to fluid loss. Consider temporary treatment interruption in patients w/ complicated UTI. Discontinue use if bullous pemphigoid is suspected. Combination w/ sulphonylurea or insulin. Assess renal function prior to initiation of treatment & periodically during treatment. Do not initiate in patients w/ & discontinue use if eGFR is persistently <45 mL/min/1.73 m². Not recommended in patients w/ severe hepatic impairment. Hepatic injury. Pregnancy. Discontinue breastfeeding during treatment. Not recommended in childn <18 yr & elderly ≥75 yr.

Vag moniliasis, vulvovaginitis, balanitis & other genital infections, UTI (including pyelonephritis & urosepsis), necrotizing fasciitis of the perineum (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; increased amylase, lipase, haematocrit, serum lipids, blood creatinine & decreased GFR.

May increase risk of hypoglycaemia w/ insulin or sulphonylureas. Not recommended to monitor glycemic control w/ 1,5-anhydroglucitol assay. Empagliflozin: May add to the diuretic effect of thiazide & loop diuretics & may increase risk of dehydration & hypotension. Concomitant use w/ lithium may decrease blood lithium levels through increased renal lithium elimination; monitor serum lithium conc more frequently w/ empagliflozin initiation or following dose changes. Risk of decreased efficacy w/ UGT enzyme inducers. Linagliptin: Decreased exposure w/ rifampicin; efficacy may be reduced when combined w/ strong P-gp or CYP3A4 inducers.

Antidiabetic Agents

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

POM